Classifications

• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/30—Dietetic or nutritional methods, e.g. for losing weight
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • A23L35/00—Foods or foodstuffs not provided for in groups A23L5/00 - A23L33/00; Preparation or treatment thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
  • A61K31/19—Carboxylic acids, e.g. valproic acid
  • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
  • A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
  • A61K31/733—Fructosans, e.g. inulin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/06—Fungi, e.g. yeasts
  • A61K36/062—Ascomycota
  • A61K36/064—Saccharomycetales, e.g. baker's yeast
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/55—Linaceae (Flax family), e.g. Linum
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
  • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23F—COFFEE; TEA; THEIR SUBSTITUTES; MANUFACTURE, PREPARATION, OR INFUSION THEREOF
  • A23F3/00—Tea; Tea substitutes; Preparations thereof

Definitions

• the present invention in general, relates to compositions that mimic fasting while still providing nutrients to a subject.
• fasting mimicking diets have been found to provide a number of health benefits.
• FMDs fasting mimicking diets
• Such fasting mimicking diets have also been found useful to promote regeneration, apoptosis of senescent cells, and other therapeutic benefits.
• Many categories of fasting type diets have become popular. These include generally behavioral fasting, physiologic fasting, molecular or cellular fasting, and combinations thereof.
• Behavioral fasting requires no consumption of food and nutrients, but often may include water consumption. Behavioral fasting can have harmful effects on a subject that result from loss of nutrition, which among other issues, may result in loss of lean muscle mass and bone density, and other possibly detrimental effects.
• Physiologic fasting involves attempts to simulate fasting by adjusting food intake to restrict carbohydrates, which induces ketosis in the body. This is accomplished by limiting carbohydrate intake, while consuming protein and high amounts of fat. Ketosis is a metabolic state characterized by elevated levels of ketone bodies in the blood or urine (7). Physiologic ketosis results from low glucose availability, which occurs when carbohydrates are limited. (0006] Ketones are always present in blood, and levels of Ketones increase when glucose reserves are low, which signals the liver to shift from metabolizing primarily carbohydrates to metabolizing fatty acids (2).
• acetyl-Coenzyme A When the liver begins to metabolize fatty acids into acetyl-Coenzyme A, and some acetyl-CoA molecules are converted into ketone bodies that include acetoacetate, beta-hy dr oxybutyrate, and acetone (2, 3).
• ketone bodies thereafter function as an energy source that replaces the lowered and/or unavailable glucose that is usually derived from carbohydrates ( ).
• the ketone bodies are released from the liver and into the blood for use by peripheral tissues including the brain (3).
• physiologic fasting is not actual fasting, because if too much protein is consumed, gluconeogenesis occurs and cells will recognize the protein as nutrient, and will not enter a fasting state (5, 6, 7).
• the third general type of fasting is known as molecular and/or cellular fasting. This provides a precisely engineered nutrient profile to sustain the body during a prolonged fast of one or more days.
• Such cellular molecular fasting provides nutrients to a subject to prevent loss of muscle and bone mass, but which constrains such nutrients to levels that are undetected by cells of a subject such that cellular molecular fasting is induced.
• the FMD is based upon this approach, and includes many variations that enable the many therapeutic benefits that result from time restricted, intermittent fasting, without the potentially undesired discomfort or detrimental loss of bone density or lean muscle mass (6, 7, 50, 51, 52).
• Metabolic syndrome is defined by co-occurrence of 3 out of 5 of the following conditions: abdominal obesity, elevated fasting glucose, elevated blood pressure, high serum triglycerides, and low levels of high-density cholesterol (HDL) (S). Affecting 47 million Americans (9), it is associated with a major increase in the risk of cardiovascular disease, and allcause mortality (10). Although prolonged fasting or very low calorie fasting-mimicking diets (FMDs) can ameliorate the incidence of diseases such as cancer and multiple sclerosis in mice (77- 13), randomized trials to assess fasting’s ability to reduce risk factors for aging and major age- related diseases have not been carried out (14-16).
• FMDs fasting or very low calorie fasting-mimicking diets
• Prolonged fasting in which only water is consumed for 2 or more days, reduces pro-growth signaling and activates cellular protection mechanisms in organisms ranging from single cell yeast to mammals (77). This is achieved in part by temporarily reducing glucose and circulating insulin-like growth factor 1 (IGF-1), a hormone well-studied for its role in metabolism, growth, and development, as well as for its association with aging and cancer (18-23). In fact, severe growth hormone receptor and IGF-1 deficiencies are associated with a reduced risk of cancer, diabetes and overall mortality in humans (24, 25). 0010] Mice fed periodically with the FMD show extended health-span and multi-system regeneration, reduced inflammation and cancer incidence, and enhanced cognitive performance (12). Despite its potential for disease prevention and treatment, prolonged fasting is difficult to implement in human subjects and may exacerbate pre-existing nutritional deficiencies, making it not feasible and/or safe for children, the elderly, frail individuals, and even for the majority of healthy adults.
• IGF-1 insulin-like growth factor 1
• a fasting mimicking diet (hereafter “FMD”) is provided.
• the FMD molecular and/or cellular fasting products and methods are enabled by a precisely engineered nutrient profile that sustains the body during such fasting, which prevents loss of muscle and bone mass, over any duration of fasting contemplated herein.
• FMDs that incorporate such precision engineered products that have the predetermined nutrient profiles disclosed herein, enable time-restricted and/or intermittent fasts over the 24-hour time period, as well as during fasts performed over hourly, daily, weekly, and other time periods.
• Such a precision engineered FMD-supplied profile of carbohydrates, protein, fats, and nutrients are precisely adjusted to predetermined ratios and levels. These ratios and levels as described in detail elsewhere herein are engineered to fall below the detection threshold of the nutrient sensors in the cells. This causes the cells to enter into a true fasting state that is nearly identical to when they are exposed to a water only, behavioral type of fast.
• the precise formulation of specific ratios and levels of carbohydrates, protein, fats, and nutrients establishes the precision engineered food constituents provided by the FMD and FMD portions and packages, which enables sustainable molecular and/or cellular fasting without detrimental consequences.
• the fasting mimicking diet (FMD) is found to be more practical and safer than fasting while providing ingredients at levels expected to enhance the effects of fasting to affect markers or risk factors for aging and diseases.
• the FMD is based on a diet previously tested in animals and designed to achieve effects similar to those caused by fasting on IGF-1, IGFBP1, glucose, and ketone bodies but not restricted to those (24).
• the FMD provides between 3000 kilojoules (hereafter “kJ”) and 4600 kJ per day, as well as high micronutrient nourishment, to each human subject (72).
• kJ 3000 kilojoules
• 4600 kJ 4600 kJ per day
• a fasting mimicking diet package providing daily meal portions for a predetermined number of days.
• the fasting mimicking diet package includes a kale cracker composition, a first vegetable broth composition, a mushroom soup composition, a tomato soup composition, a quinoa-containing minestrone soup composition, a bean-containing minestrone soup composition, and a pumpkin soup composition.
• the daily meal portions are packaged into meal servings or into a total daily serving to be divided into meals.
• another fasting mimicking diet package providing daily meal portions for a predetermined number of days.
• the fasting mimicking diet package includes a nut-containing nutrition bar, a cocoa-containing nutrition bar, a first olive-containing composition, a kale cracker composition, a vegetable soup composition, and a first vegetable broth composition, a tea composition that includes spearmint, an energy drink composition, a micronutritional composition, and an algal oil composition.
• the daily meal portions are packaged into meal servings or into a total daily serving to be divided into meals.
• An additionally contemplated fasting mimicking diet package provides a one-day FMD that includes three meal portions to be consumed over a single day period of fasting.
• the FMD package includes breakfast, lunch and dinner meal portions.
• the breakfast meal portion includes a nut containing nutrition bar composition, two micronutritional vegetable powder with vitamin and mineral supplements, and two algal oil composition nutritional supplements.
• the lunch meal portion includes a soup composition and a kale cracker composition.
• the dinner meal portion that completes the one-day FMD package includes another soup composition, an olive containing composition, and i of another nutrition bar composition.
• At least one of the breakfast, lunch, and dinner meal portions may also optionally include an energy drink composition and a tea composition that includes spearmint, hibiscus, and/or lemon or other constituents.
• Another variation may include alternative nutrition bars and/or soups as described elsewhere herein.
• the fasting mimicking diet packages set forth herein can be used to alleviate symptoms of chemotherapy, promote cell regeneration, alleviate symptoms of aging, treat or prevent diabetes, treat or prevent metabolic disorder, treat or prevent hypertension, induce senescent cell apoptosis, and help prevent cancer when administered to a subject identified has having symptoms of these ailments.
• FIGURE 1 A is a schematic illustration of a fasting mimicking diet package.
• FIGURE IB Consort Diagram.
• Consort Diagram of 102 contacted subjects of which 100 were enrolled into the study two arms.
• FMD fasting-mimicking diet
• FIGURES 2A, 2B, 2C, 2D, 2E, 2F, 2G, 2H, 21, 2J, 2K, 2L, 2M, 2N, and 20 Change analysis of metabolic variables during the randomization. Effects on aging/disease markers and risk factors in all subjects that completed the randomized analysis in either the control arm or in the FMD arm (5-7 days after the third cycle of FMD). The A change represents a comparison to baseline. All data are presented as mean ⁇ SD. Between-arm comparisons were calculated using two-tailed two-sample equal variance t-tests. For some of the 100 enrolled participants, the nurses were unable to collect all the samples/measurements from all subjects. We therefore excluded subjects with incomplete measurements from a particular marker group. See Table 2 for details.
• FIGURES 3A, 3B, 3C, 3D, 3E, 3F, 3G, 3H, 31, and 3J Post-hoc analysis of metabolic variables in subgroups identified by severity of risk factors. Subjects from both study arms who completed three FMD cycles were post-hoc stratified based on being either in normalrisk or at-risk subgroups for factors associated with age-related diseases and conditions. The A change shown represents comparisons to baseline. All data are presented as mean ⁇ SD. Between- arm comparisons were calculated using two-tailed two-sample equal variance t-tests. One-way analysis of variance was used for the BMI groups. See Table 4 for details.
• FIGURE 4 Subject self-reported adverse effects based on Common Terminology Criteria for Adverse Effects.
• FIGURE 5 Comparison of participants that completed the trial vs. dropouts.
• FIGURES 6A through 6J Baseline to 3 months before/after comparison of individual subjects in the control cohort and all subjects that completed the FMD.
• FIGURES 7A through 7G Nutritional Information of nutritional bar constituents of the Fasting Mimicking Diet.
• FIGURE 8 is Table 1 which provides the baseline characteristics of the Subjects.
• FIGURE 9 is Table 2 which provides study arm-specific biomarkers of adherence and changes in risk factors.
• FIGURE 10 is Table 3 which provides comparisons of changes in risk factors by baseline subgroups.
• FIGURE 11 is Table 4 which provides post hoc analysis of risk factors for age- related diseases and conditions, diabetes and cardio- vascular disease in at-risk subjects.
• FIGURE 12 is Table 5 which provides a Complete Metabolic Panel.
• FIGURE 13 A and 13B are Table 6 which provides Arm-specific Markers of
• FIGURE 14 is Table 7 which provides Changes in Risk factors and Metabolic markers of Adherence after the first FMD.
• FIGURE 15 is Table 8 which provides Changes in Risk factors and Metabolic markers of Adherence 3 months after Intervention.
• FIGURE 16 is another illustration of a one-day fasting mimicking diet package.
• FIGURES 17A through 17H Nutritional Information of nut containing nutritional bar compositions of the Fasting Mimicking Diet providing alternative variations of FIG. 7E.
• FIGURE 18 illustrates Nutritional Information of micronutritional vegetable powder with vitamin and mineral supplements of the FMD, which are modified from that of FIG. 7H.
• FIGURE 19 depicts a variation of the FMD algal oil composition nutritional supplement of FIG. 7G.
• FIGURE 20 provides Nutritional Information for a modified kale cracker composition of the FMD, similar to that of FIG. 7F.
• FIGURES 21A through 211 Nutritional Information of soup composition constituents of the Fasting Mimicking Diet providing alternative variations of the soup compositions of FIGS. 7A, 7B, and 7C.
• FIGURES 22 and 23 show Nutritional Information for olive containing compositions of the FMD.
• FIGURE 24 provides examples of tea composition that include spearmint, hibiscus, and/or lemon or other constituents.
• FIGURES 25 and 26 depict Nutritional Information of energy drink compositions of the FMD, as alternative examples of that shown in FIG. 7D.
• FIGURE 27 is a table of results of a one-day fast meal plan protocol directed to test subjects consuming an FMD breakfast, lunch, and dinner, for a single day, and being tested at predetermined times to measure their respective blood glucose and ketone levels.
• FIGURE 28 reflects average blood ketone level measurements of test subjects at predetermined, selected times during the one-day fast protocol of FIG 27.
• FIGURE 29 shows average blood glucose level measurements of the same test subjects of FIGS. 26 and 27 and at the same selected times.
• the term “subject” refers to a human or animal, including all mammals such as primates (particularly higher primates), sheep, dog, rodents (e.g., mouse or rat), guinea pig, goat, pig, cat, rabbit, and cow.
• fasting mimicking and enhancing diet means a diet that mimics the effects of fasting typically by providing a subject with at most 50-75 % of their normal caloric intake, but with a nutritional component so that fasting is mimicked while a subject is not completely starved. However, if the fasting mimicking diet composition is maintained, based on our current and previous findings, partial disease prevention and treatment effects are anticipated even if 100% of the normal caloric intake is provided to subjects.
• fasting mimicking and enhancing diet is sometimes simply referred to as a “fasting mimicking diet.”
• such a fasting mimicking diet is ketogenic since it causes an increase in ketone bodies and stimulates ketone body-based metabolism, so it can also be referred to as a ketogenic FMD.
• FMD affects IGF-1, AKT and TOR signaling by regulation of growth hormone signaling upstream of IGF-1. It also affects the levels of glucose, the release of insulin, and the levels of the hunger hormone leptin. Low levels of IGF - 1, leptin, insulin, and glucose, and higher levels of ketone bodies and IGFBP1 cooperate to promote the beneficial effects of the FMD.
• a diet package for administering a fasting mimicking diet is provides.
• the fasting mimicking diet package provides daily meal portions for a predetermined number of days. Typically, the predetermined number of days is from 1 to 10 days (i.e., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 days).
• the predetermined number of days is 5 or 6 days.
• the fasting mimicking diets set forth herein provide a subject at most, in increasing order of preference, 75%, 50%, 40%, 30%, or 10% of the subject’s normal caloric intake or the daily recommended caloric intake for a subject.
• the fasting mimicking diet provides at least, in increasing order of preference, 5%, 10%, or 20% of the subject’s normal caloric intake or the daily recommended caloric intake for a subject.
• the subject’s normal caloric intake is the number of kilocalories (hereafter “kcal”) that the subject consumes to maintain his/her weight.
• the subject’s normal caloric intake may be estimated by interviewing the subject or by consideration of a subject’s weight. As a rough guide, subject’s normal caloric intake is on average 2600 kcal/day for men and 1850 kcal/day for women. In certain instances, the fasting mimicking diet provides the subject with 700 to 1200 kcal/day.
• the fasting mimicking diet provides a male subject of average weight with about 1100 kcal/day and a female subject of average weight with 900 kcal/day.
• the diet from the diet package is administered on consecutive days.
• the daily meal portions provided for only one day a week for at least a month.
• the fasting mimicking diet package provides daily meal portions for a predetermined number of days as set forth above.
• the fasting mimicking diet package includes a kale cracker composition, a first vegetable broth composition, a mushroom soup composition, a tomato soup composition, a quinoa-containing minestrone soup composition, a bean-containing minestrone soup composition, and a pumpkin soup composition.
• the daily meal portions are packaged into meal servings or into a total daily serving to be divided into meals.
• the fasting mimicking diet package further includes a nut-containing nutrition bar, a cocoa-containing nutrition bar, a first olive-containing composition, a first vegetable broth composition, a tea composition that includes spearmint, an energy drink composition, a micronutritional composition, and an algal oil composition.
• the fasting mimicking diet package further includes a second olive-containing composition, a second vegetable broth composition, a tea composition that includes spearmint and lemon, and a tea composition that includes hibiscus.
• the fasting mimicking diet package includes daily meal portions that provide less than 40 grams of sugar for day 1, less than 30 grams of sugar for days 2 to 5 and any remaining days, less than 28 grams of protein for day 1, less than 18 grams of protein for days 2 to 5 and any remaining days, 20-30 grams of monounsaturated fats or more to reach the desired caloric intake (i.e., a predetermined caloric intake) for day 1, 6-10 grams of polyunsaturated fats or more to reach the desired caloric intake for day 1, 2-12 grams of saturated fats or more to reach the desired caloric intake for day 1, 10-15 grams of monounsaturated fats or more to reach the desired caloric intake for days 2 to 5 and any remaining days, 3-5 grams of polyunsaturated fats or more to reach the desired caloric intake for days 2 to 5 and any remaining days, 1-6 grams of saturated fats or more to reach the desired caloric intake for days 2 to 5, or any remaining days, and a micronutrient
• the fasting mimicking diet package includes daily meal portions 8-10 kcal per kilogram body weight for each diet day.
• the fasting mimicking diet provides less than 30 grams of sugar for each diet day, less than 18 grams of protein for each diet day, 9-15 grams of monounsaturated fats or more to reach the desired caloric intake for each diet day, and 2.5-4.5 grams of polyunsaturated fats or more to reach the desired caloric intake for each diet day and 1-5.5 grams of saturated fats or more to reach the desired caloric intake for each diet day.
• Higher levels of the fats listed above can be provided for higher FMD formulation providing up to 100% of the normal caloric intake to subjects.
• the fasting mimicking diet package includes daily meal portions that provide 5-8 kcal per kilogram body weight for each diet day.
• the fasting mimicking diet provides less than 20 grams of sugar for each diet day, less than 12 grams of protein for each diet day, and 6.5-10 grams of monounsaturated fats or more to reach the desired caloric intake for each diet day, 2.5-4.5 grams of polyunsaturated fats or more to reach the desired caloric intake for each diet day and 1.5-4 grams of saturated fats or more to reach the desired caloric intake for each diet day.
• the fasting mimicking diet package includes daily meal servings that provide 0-3 kcal per kilogram body weight for each diet day.
• the fasting mimicking diet provides less than 5 grams of sugar for each diet day, less than 3 grams of protein for each diet day, and less than 2.5 grams of monounsaturated fats for each diet day, less than 1 grams of polyunsaturated fats for each diet day and less than 1 grams of saturated fats for each diet day.
• the nutritional requirements for the fasting mimicking diet set forth above can be realized by a diet package with certain specific meal components.
• the fasting mimicking diet package 10 provides daily meal portions for a predetermined number of days are set forth above (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 days).
• the fasting mimicking diet package 10 includes a kale cracker composition (item 12), a first vegetable broth composition (item 14), a mushroom soup composition (item 16), a tomato soup composition (item 18), a quinoa-containing minestrone soup composition (item 20), a beancontaining minestrone soup composition (item 22), and a pumpkin soup composition (item 24).
• the daily meal portions are packaged into meal servings or into a total daily serving to be divided into meals.
• the fasting mimicking diet package further includes a nut-containing nutrition bar (item 26), a cocoa-containing nutrition bar (item 28), a first olive-containing composition (item 30), a first vegetable broth composition (item 32), a tea composition that includes spearmint (item 34), an energy drink composition (item 36), a micronutritional composition (item 38), and a algal oil composition (item 40).
• the fasting mimicking diet package further includes a second olive-containing composition (item 42), a second vegetable broth composition (item 44), a tea composition that includes spearmint and lemon (item 46), and a tea composition that includes hibiscus (item 48).
• a second olive-containing composition item 42
• a second vegetable broth composition item 44
• a tea composition that includes spearmint and lemon item 46
• a tea composition that includes hibiscus e.g., hibiscus
• diet package 10 includes a nut-containing nutrition bar (item 26), a cocoa-containing nutrition bar (item 28), a first olivecontaining composition (item 30), a kale cracker composition (item 12), a vegetable soup composition (item 14), a first vegetable broth composition (item 14), a tea composition that includes spearmint (item 34), an energy drink composition (item 36), a micronutritional composition (item 38), and a algal oil composition (item 40).
• the daily meal portions are packaged into meal servings or into a total daily serving to be divided into meals.
• This diet package also includes daily meal portions for a predetermined number of days as set forth above with the daily meal portions being packaged into meal servings or into a total daily serving to be divided into meals.
• the fasting mimicking diet package further includes a mushroom soup composition (item 16), a tomato soup composition (item 18), a quinoa-containing minestrone soup composition (item 20), and a pumpkin soup composition.
• the fasting mimicking diet package further includes a second olive-containing composition (item 42), a second vegetable broth composition (item 44), a bean-containing minestrone soup composition (item 22), a tea composition that includes spearmint and lemon (item 46), and a tea composition that includes hibiscus (item 48).
• the fasting mimicking diet packages includes specific meal components.
• compositions are as follows.
• the nut-containing nutrition bar includes almond meal and macadamia nuts.
• the cocoa-containing nutrition bar includes almond butter, almonds, and brown rice crispy (e.g., brown puffed rice).
• the mushroom soup composition includes brown rice powder, carrots, inulin, and mushrooms.
• the bean-containing minestrone soup composition includes white beans, cabbage, and potatoes.
• the first vegetable broth composition includes carrots, maltodextrin, celery, spinach, and tomatoes.
• the second vegetable broth composition includes carrots, maltodextrin, celery, spinach, soy lecithin, and tomatoes.
• the energy drink composition includes glycerin and water.
• the algal oil composition includes schizocatrium algae oil.
• the micronutrient composition includes beet root powder, calcium carbonate, carrots, collard leaf, kale leaf, and tomatoes.
• the micronutrient composition includes Vitamin A (hereafter “Vit”), Vit C, Ca, Fe, Vit D3, Vit E, Vit K, Vit Bl, Vit B2, Vit B3, Vit B5, Vit B6, Vit B7, Vit B9, Vit B 12, Cr, Cu, I, Mg, Mn, Mo, Se, and Zn.
• the nut-containing nutrition bar (L-Bar Nut based, available from L-Nutra Inc.) includes almond meal and macadamia nuts.
• the nut-containing nutrition bar includes almond meal preferably in an amount of 20 to 35 weight %; coconut preferably in an amount of 2 to 10 weight %; coconut oil preferably in an amount of 1 to 8 weight %; flax seed meal preferably in an amount of 1 to 8 weight %; honey preferably in an amount of 10 to 30 weight %; macadamia nuts preferably in an amount of 10 to 30 weight %; pecans preferably in an amount of 10 to 25 weight %; salt preferably in an amount of 0.1 to 0.8 weight %; and optionally vanilla preferably in an amount of 0.3 to 1.5 weight %.
• the cocoa-containing nutrition bar (L-Bar ChocoCrisp, available from L-Nutra Inc.) includes almond butter, almonds, and brown rice crispy (PGP 10235).
• the cocoa-containing nutrition bar (L-Bar ChocoCrisp) includes almond butter preferably in an amount of 10 to 25 weight %; almonds preferably in an amount of 3 to 12 weight %; brown rice crispy (PGP 10235) preferably in an amount of 10 to 25 weight %; brown rice syrup preferably in an amount of 2 to 8 weight %; chocolate liquor preferably in an amount of 1 to 4 weight %, cocoa butter preferably in an amount of 0.4 to 1.6 weight %; cocoa powder preferably in an amount of 4 to 12 weight %; fiber syrup SF75 preferably in an amount of 18 to 38 weight %, flax seed oil preferably in an amount of 1 to 3 weight %; salt preferably in an amount of 0.1 to 0.4 weight % and sugar preferably in an amount of 1
• the first olive-containing composition incudes olives, olive oil, and sea salt.
• the first olive-containing composition includes lactic acid preferably in an amount of 0.3 to 1 weight %; oil (olive) preferably in an amount of 2 to 6 weight %; olives (raw, green pitted) preferably in an amount of 50 to 97 weight %; salt (reg., kosher, sea salt) preferably in an amount of 0.8 to 3 weight %; and thyme preferably in an amount of 0.1 to 0.5 weight %.
• the second olive-containing composition incudes olives, olive oil, and garlic.
• the second olive-containing composition includes garlic preferably in an amount of 0.1 to 0.6 weight %; lactic acid preferably in an amount of 0.3 to 1 weight %; oil (olive) preferably in an amount of 2 to 6 weight %; olives (raw, green pitted) preferably in an amount of 50 to 97 weight %; salt (reg., kosher, sea salt) preferably in an amount of 0.8 to 3 weight %; thyme preferably in an amount of 0.1 to 0.5 weight %.
• the kale cracker composition includes kale, almonds, tapioca flour, and optionally sesame seeds.
• the kale cracker composition includes almonds preferably in an amount of 15 to 40 weight %; black pepper preferably in an amount of 0.1 to 0.4 weight %; chia seeds preferably in an amount of 3 to 10 weight %; chili pepper preferably in an amount of 0.4 to 1.2 weight %; cumin seeds preferably in an amount of 0.3 to 0.9 weight %; flax seeds preferably in an amount of 3 to 10 weight %; garlic preferably in an amount of 0.02 to 0.04 weight %; kale preferably in an amount of 2 to 6 weight %; oil (sun flower) preferably in an about of 2 to 7 weight %; onion (powder, minced) typically in an amount of 0.3 to 0.9 weight%; oregano preferably in an amount of 0.01 to 0.06 weight %; salt preferably in an amount of 1 to 4 weight
• the kale cracker composition includes kale, flax seeds golden, sesame seeds, and sunflower seeds.
• the apple cider vinegar preferably in an amount 1 to 3 weight %; black pepper preferably in an amount of 0.4 to 1.3 weight %; cashews preferably in an amount of 4 to 13 weight %; dill weed preferably in an amount of 0.4 to 1.3 weight %; flax seeds golden preferably in an amount of 13 to 40 weight %; hemp seeds preferably in an amount of 0.7 to 2 weight %; kale preferably in an amount of 14 to 42 weight %; onion, white, dried, (powder, minced) preferably in an amount of 0.5 to 1.6 weight %; pumpkin seeds preferably in an amount of 0.7 to 2 weight %; salt (reg.
• kosher, sea salt preferably in an amount of 0.7 to 2 weight %; Sesame seeds preferably in an amount of 2 to 8 weight %; sunflower seeds preferably in an amount of 10 to 30 weight %; and yeast extract preferably in an amount of 1 to 5 weight %.
• the vegetable soup composition includes onions, tomatoes, spinach, green tree extract, optionally rice flour, optionally brown rice powder, optionally carrots, and optionally inulin, leeks
• the vegetable soup composition includes basil (whole leaf, dried) preferably in an amount of 0.3 to 0.9 weight %; brown rice powder (whole grain) preferably in an amount of 3 to 12 weight %; carrot (dehydrated, puffed, powder, pieces) preferably in an amount of 4 to 14 weight %; green tea extract preferably in an amount of 0.02 to 0.06 weight %; inulin preferably in an amount of 5 to 15 weight %; leeks (granules -10+40) preferably in an amount of 1 to 5 weight %; oil (olive) preferably in an amount of 1 to 6 weight %; onion (powder, minced) preferably in an amount of 4 to 15 weight %; parsley preferably in an amount of 0.3 to 0.8 weight %; red bell peppers preferably in
• the vegetable soup composition includes carrots, inulin, leeks, onions and rice flour.
• the vegetable soup composition includes basil, whole leaf, dried preferably in an amount of 0.3 to 1 weight %; carrot (dehydrated, puffed, powder, pieces) preferably in an amount of 4 to 12 weight %; inulin preferably in an amount of 6 to 18 weight %; leeks in an amount of 1 to 5 weight %; oil (olive) preferably in an amount of 1 to 3 weight %; Onion, white, dried, (powder, minced) preferably in an amount of 10 to 30 weight %; parsley preferably in an amount of 0.3 to 1 weight %; potato preferably in an amount of 1 to 5 weight %; red pepper preferably in an amount of 1 to 6 weight %; rice flour in an amount of 13 to 40 weight %; salt (reg.
• the mushroom soup composition includes mushrooms, green tea extract, optionally brown rice powder, optionally carrots, and optionally inulin.
• the mushroom soup composition includes brown rice powder (whole grain) preferably in an amount of 10 to 30 weight %; carrot (dehydrated, puffed, powder, pieces) preferably in an amount of 3 to 12 weight %; green tea extract preferably in an amount of 0.02 to 0.06 weight %; inulin preferably in an amount of 3 to 12 weight %; mushrooms (European mix, powder, pieces) preferably in an amount of 6 to 18 weight %; oil (olive) preferably in an amount of 1 to 6 weight %; onion preferably in an amount of powder, minced) preferably in an amount of 3 to 12 weight %; parsley preferably in an amount of 0.1 to 0.5 weight %; rice flour preferably in an amount of 18 to 50 weight %; salt preferably in an amount of 2 to 8 weight %; yeast extract preferably in an amount of 0.5 to 1.5
• the mushroom soup composition includes carrots, inulin, mushrooms, onions, and rice flour.
• the mushroom soup composition includes carrot (dehydrated, puffed, powder, pieces) preferably in an amount of 7 to 22 weight %; inulin preferably in an amount of 7 to 22 weight %; mushrooms (European mix), (powder & pieces)dehydrated preferably in an amount of 7 to 22 weight %; oil (olive) preferably in an amount of 0.6 to 2 weight %; Onion, white, dried, (powder, minced) preferably in an amount of 7 to 22 weight %; parsley preferably in an amount of 0.3 to 0.9 weight %; potato preferably in an amount of 0.6 to 2 weight %; rice flour preferably in an amount of 15 to 45 weight %; salt (reg. , kosher, sea salt) preferably in an amount of 6 to 18 weight %; and yeast extract preferably in an amount of 0.7 to 2.2 weight %.
• salt reg. , kosher, sea salt
• the tomato soup composition includes tomatoes, green tea extract, optionally inulin, and optionally onions.
• the tomato soup composition (new) includes basil (whole leaf, dried) preferably in an amount of 0.2 to 0.7 weight %; brown rice powder (whole grain) preferably in an amount of 1 to 5 weight %; green tea extract preferably in an amount of 0.02 to 0.06 weight %; inulin preferably in an amount of 7 to 20 weight %; oil (olive) preferably in an amount of 3 to 9 weight %; onion preferably (powder, minced) preferably in an amount of 4 to 12 weight %; parsley preferably in an amount of 0.1 to 0.6 weight %; rice flour preferably in an amount of 18 to 50 weight %; salt preferably in an amount of 2 to 9 weight %; tomatoes (fruit powder, sun dried, granules) preferably in an amount of 12 to 36 weight %; and yeast extract preferably in an amount of 0.5 to 3 weight %
• the tomato soup composition includes tomatoes, inulin, olives, onions, potatoes, and rice flour.
• the tomato soup composition includes basil, whole leaf, dried preferably in an amount of 0.3 to 1 weight %; inulin preferably in an amount of 6 to 18 weight %; oil (olive) preferably in an amount of 4 to 14 weight %; onion, white, dried, (powder, minced) preferably in an amount of 8 to 24 weight %; parsley preferably in an amount of 0.3 to 0.9 weight %; potato preferably in an amount of 6 to 18 weight %; rice flour preferably in an amount of 9 to 27 weight %; salt (reg.
• the quinoa-containing minestrone soup composition includes quinoa, green tea extract, optionally olive oil, optionally cabbage, optionally potatoes, optionally rice flour, and optionally tomatoes and optionally no turmeric.
• the quinoacontaining minestrone soup composition includes basil (whole leaf, dried preferably in an amount of 0.7 to 2 weight %; broccoli powder preferably in an amount of 0.6 to 2 weight %; cabbage white (flakes) preferably in an amount of 3 to 10 weight %; carrot (dehydrated, puffed, powder, pieces) preferably in an amount of 3 to 10 weight %; celery preferably in an amount of 1 to 4 weight %; celery seeds (powder) preferably in an amount of 0.07 to 0.2 weight %; garlic preferably in an amount of 0.7 to 2 weight %; green tea extract preferably in an amount of 0.02 to 0.06 weight %; inulin preferably in an amount of 1 to 5 weight % ; leeks (granules -10+40), preferably in an amount of 0.7 to 2 weight %; oil (olive) preferably in an amount of 0.6 to 2 weight %; onion (powder, minced) preferably in an amount of 2 to 8 weight %; peroxineum a
• the quinoa-containing minestrone soup includes quinoa, cabbage, potatoes, and rice flour.
• the quinoa-containing minestrone soup includes basil, whole leaf, dried preferably in an amount of 0.7 to 2.2 weight %; broccoli powder preferably in an amount of 0.7 to 2.2 weight %; cabbage white (flakes) preferably in an amount of 0.6 to 2.2 weight %; carrot (dehydrated, puffed, powder, pieces) preferably in an amount of 3 to 10 weight %; celeriac preferably in an amount of 2 to 6 weight %; celery seeds powder preferably in an amount of 0.6 to 1.8 weight %; garlic preferably in an amount of 1 to 3 weight %; Onion, white, dried, (powder, minced) preferably in an amount of 3 to 9 weight %; peas preferably in an amount of 3 to 10 weight %; potato preferably in an amount of 6 to 20 weight %; quinoa preferably in an amount of 8 to 23
• the bean-containing minestrone soup composition includes white beans (e.g., great northern beans), great tea extract, optionally cabbage, and optionally potatoes.
• the bean-containing minestrone soup composition includes beans (great northern) preferably in an amount of 3 to 10 weight %; cabbage white (flakes) preferably in an amount of 2 to 8 weight %; carrot (dehydrated, puffed, powder, pieces) preferably in an amount of 2 to 8 weight %; celery preferably in an amount of 1 to 4 weight %; green tea extract preferably in an amount of 0.02 to 0,06 weight %; inulin preferably in an amount of 2 to 10 weight %; leeks (granules - 10+40) preferably in an amount of 2 to 7 weight %; oil (olive) preferably in an amount of 2 to 7 weight %; onion (powder, minced) preferably in an amount of 2 to 7 weight %; parsley preferably in an amount of 0.2 to 1 weight %; peas preferably in an amount of 3 to 9 weight %; potato preferably in an amount of 15 to 45 weight %; rice flour preferably in an amount of 6 to 18 weight %;
• the bean-containing minestrone soup composition includes brown beans, carrots, peas, potato, and rice flour.
• the bean-containing minestrone soup composition includes carrot (dehydrated, puffed, powder, pieces) preferably in an amount of 4 to 14 weight %; celeriac preferably in an amount of 1 to 5 weight %; celery preferably in an amount of 0.5 to 1.6 weight %; leeks preferably in an amount of 2 to 8 weight %; oil (olive) preferably in an amount of 2 to 8 weight %; Onion, white, dried, (powder, minced) preferably in an amount of 3 to 10 weight %; parsley preferably in an amount of 0.5 to 1.5 weight %; peas preferably in an amount of 5 to 18 weight %; potato preferably in an amount of 8 to 24 weight %; rice flour preferably in an amount of 5 to 18 weight %; salt (reg.
• the pumpkin soup composition includes pumpkin, green tree extract, optionally rice flour, optionally carrots, and optionally brown rice powder.
• the pumpkin soup composition includes (new) includes brown rice powder (whole grain) preferably in an amount of 3 to 9 weight %; carrot (dehydrated, puffed, powder, pieces) preferably in an amount of 2 to 8 weight %; green tea extract preferably in an amount of 0.02 to 0.06 weight %; inulin preferably in an amount of 2 to 10 weight %; oil (olive) preferably in an amount of 1 to 7 weight %; onion (powder, minced) preferably in an amount of 1.0 to 3 weight %; pumpkin powder preferably in an amount of 20 to 60 weight %; rice flour preferably in an amount of 15 to 45 weight %; salt preferably in an amount of 2 to 10 weight %; and yeast extract preferably in an amount of 0.3 to 1 weight %.
• the first vegetable broth includes carrots, maltodextrin, celery, spinach, and tomatoes.
• the first vegetable broth includes carrot (dehydrated, puffed, powder, pieces) preferably in an amount of 6 to 18 weight %; celery preferably in an amount of 3 to 10 weight %; garlic preferably in an amount of 3 to 10 weight %; maltodextrin preferably in an amount of 8 to 25 weight %; oil (canola) preferably in an amount of 0.5 to 2 weight %; onion (powder, minced) preferably in an amount of 6 to 18 weight %; parsley preferably in an amount of 3 to 10 weight %; potato preferably in an amount of 1 to 3 weight %; salt preferably in an amount of 7 to 21 weight %; spinach (leaf, powder) preferably in an amount of 3 to 10 weight %; tomatoes (fruit powder, sun dried, granules) preferably in an amount of 6 to 18 weight %; and yeast extract
• the second vegetable broth includes carrots, chicken flavoring, maltodextrin, celery, spinach, soy lecithin, and tomatoes.
• the second vegetable broth composition includes carrot (dehydrated, puffed, powder, pieces) preferably in an amount of 3 to 10 weight %; celery preferably in an amount of 3 to 12 weight %; garlic preferably in an amount of 3 to 9 weight %; maltodextrin preferably in an amount of 8 to 25 weight %; oil (canola) preferably in an amount of 0.5 to 2 weight %; onion preferably in an amount of powder, minced) preferably in an amount of 3 to 12 weight %; parsley preferably in an amount of 3 to 10 weight %; potato preferably in an amount of 1 to 6 weight %; salt preferably in an amount of 8 to 25 weight %; soy lecithin preferably in an amount of 0.5 to 3 weight %; spinach (leaf, powder) preferably in an amount of 0.5 to 3 weight %; spinach (leaf, powder)
• the energy drink composition includes glycerin preferably in an amount of 20 to 60 weight %; water (purified) preferably in an amount of 40 to 80 weight %.
• the tea composition that includes spearmint includes spearmint leaves organic preferably in an amount of 70 to 100 weight %.
• the tea composition that includes lemon and spearmint includes lemon myrtle organic preferably in an amount of 3 to 12 weight %; lemon peel organic preferably in an amount of 10 to 25 weight %; spearmint leaves organic preferably in an amount of 50 to 95 weight %.
• the tea composition that includes hibiscus includes hibiscus tea leaves organic preferably in an amount of 80 to 100 weight %.
• the algal oil composition includes schizocatrium algae oil (DHA Omega-3) preferably in an amount of 80 to 100 weight %.
• DHA Omega-3 schizocatrium algae oil
• the nutrient replenishment composition (NR-1) includes beet root powder, calcium carbonate, carrots, collard leaf, kale leaf, and tomatoes.
• the nutrient replenishment composition (NR-1) includes ascorbic acid preferably in an amount of 1 to 3 weight %; beet root powder preferably in an amount of 6 to 20 weight %; beta carotene preferably in an amount of 0.05 to 0.15 weight %; calcium carbonate preferably in an amount of 6 to 20 weight %; carrot (dehydrated, puffed, powder, pieces) preferably in an amount of 6 to 20 weight %; cholecaliciferol preferably in an amount of 0.00 weight %; chromium Picolinate preferably in an amount of 0.00 weight %; collard leaf powder preferably in an amount of 6 to 20 weight %; cupric sulfate preferably in an amount of 0.01 to 0.06 weight %; cyanocobalamin, 0.00; Dl-alpha
• each of the components of the fasting mimicking diet package and therefore the fasting mimicking diet is substantially gluten free (e.g., each component has less than 20 ppm gluten) or very low gluten (e.g., each component has 20-100 ppm).
• each of the components are provided in a serving size from 20 to 60 g.
• the nutcontaining nutrition bar is provided in a serving size from 30 to 60 g; cocoa-containing nutrition bar is provided in a serving size from 15 to 40 g; the olive containing composition (sea salt version) in a serving size from 10 to 20 g; the olive containing composition (garlic version) in a serving size from 10 to 20 g; kale cracker composition is provides in a serving size from 30 to 60 g;
• the kale cracker compositions are provided in a serving size from 20 to 50 g;
• the vegetable soup compositions are provided in a serving size from 20 to 50 g;
• the mushroom soup compositions are provided in a serving size from 20 to 50 g;
• the tomato soup compositions are provided in a serving size from 20 to 50 g;
• the bean-containing minestrone soup compositions are provided in a serving size from 20 to 50 g; the quinoa-containing minestrone soup compositions are provided in a serving size from 20 to 50 g;
• the pumpkin soup compositions
• Figures 7A-H provide nutritional information for each of the meal components. It should be appreciated that variations of these values can vary by +/- 30 percent. In other variations, the meal components are provide is sufficient amounts to meet the caloric and nutritional requirements in these figures.
• the table set forth below provides a schedule of administration for two FMD meal plans to be administered to a subject.
• the Prolon(r) Meal plan (available from L-Nutra Inc.) is useful for weight loss, treating or preventing hypertension, metabolic disease, diabetes, and the like.
• the Chemolieve(r) (also available from L-Nutra Inc.) meal plan is useful for alleviating the side effect of chemotherapy. Therefore, the diet packages set forth herein can include instruction providing the schedules and instructions for administering the FMD to treat various conditions as set forth in the methods below.
• a method for inducing differential effects on disease factors and markers associated with aging includes a step of identifying a subject in need of modifying disease factors and markers associated with aging. Expression of the factors and marker might be decreased or increased depending on which direct results in a health benefit.
• the fasting mimicking diet provided by the diet packages set forth above is administered to a subject for a predetermined period of time as set forth above.
• diseases factors and markers are insulin-like growth factor- 1, blood glucose, systolic or diastolic blood pressure, insulin-like growth factor- 1, blood glucose, systolic blood pressure, diastolic blood pressure, cholesterol, CRP, triglycerides, or abdominal/visceral fats.
• a method of promoting and inducing beneficial long- lasting effects on disease factors and markers associated with aging includes a step of identifying a subject in need of modifying disease factors and markers associated with aging. Expression of the factors and marker might be decreased or increased depending on which direct results in a health benefit.
• the fasting mimicking diet provided by the diet packages set forth above is administered to a subject for a predetermined period of time as set forth above. Examples of such disease factors and markers are insulin-like growth factor-1, blood glucose, systolic blood pressure, diastolic blood pressure, cholesterol, CRP, triglycerides, or abdominal/visceral fats.
• a method for promoting and inducing stem-cell based regeneration of multiple organs and systems includes a step of identifying a subject in need of promoting and inducing stem-cell based regeneration of multiple organs and systems.
• the fasting mimicking diet provided by the diet packages set forth above is administered to a subject for a predetermined period of time as set forth above.
• Examples of stem-cell based regeneration of multiple organs and systems include, but are not limited to, neurogenesis, hematopoiesis, or promotion of pancreatic beta-cells.
• a method for promoting and inducing stem cell-based rejuvenation of multiple organs and systems includes a step of identifying a subject in need of promoting and inducing stem-cell based rejuvenation of multiple organs and systems.
• the fasting mimicking diet provided by the diet packages set forth above is administered to a subject for a predetermined period of time as set forth above.
• Examples of stem cell-based regeneration of multiple organs and systems include, but are not limited to, neurogenesis, hematopoiesis, or promotion of pancreatic beta-cells.
• a graphical summary of these data is presented in Fig. 2. In conclusion, 3 cycles of the FMD reduced body weight, trunk and total body fat, blood pressure and IGF-1 in comparison to a standard diet.
• the 25% dropout rate for participants during the FMD is higher than the 10% dropout rate observed during control diet in arm 1, but this is expected considering that subjects in control diet group only dropped out because of scheduling conflicts since they were was allowed to remain on their own diet.
• body weight p ⁇ 0.0001
• BMI p ⁇ 0.0001
• absolute lean body mass p ⁇ 0.0001
• waist circumference p ⁇ 0.0001
• fasting glucose p ⁇ 0.0001
• IGF-1 p ⁇ 0.0001
• diastolic blood pressure p ⁇ 0.0003
• triglycerides p ⁇ 0.0001
• LDL LDL
• Fasting glucose did not change from baseline levels for participants with baseline levels ⁇ 99 mg/dl but was reduced by
• a post hoc analysis also allowed us to analyze subjects with elevated risk factors or metabolic markers associated with metabolic syndrome and age-related diseases, such as high BMI, blood pressure, fasting glucose, triglycerides, CRP, cholesterol and IGF-1.
• the FMD had more pronounced effects on all these markers in at-risk participants than in those subjects who had risk factor values within the normal range, with the exception of HDL.
• Some of these metabolic markers namely CRP, systolic/diastolic blood pressure, and serum lipids, have been proposed as markers of biological aging (33).
• IGF-1 and glucose have been strongly implicated in aging and age-related diseases (12, 25, 34).
• Eligible participants were randomly assigned, using a random -number generator, to either arm 1 or arm 2 of the study. All participants completed a health habits questionnaire. Prespecified outcome measures included safety and feasibility, and evaluation of changes in metabolic risk factors for diabetes and cardiovascular disease and metabolic markers associated with age- related diseases and mortality; these outcomes were measured at baseline, during and after completion of the intervention. Lab examinations included height, weight, body composition (including total and trunk body fat, soft lean tissue, and bone mineral content) measured by dual energy x-ray absorptiometry (DEXA), oscillometric blood pressure measurements and over-night fasting blood draw through venipuncture.
• DEXA dual energy x-ray absorptiometry
• the fasting mimicking diet is a plant-based diet designed to attain fasting-like effects on the serum levels of IGF-1, IGFBP1, glucose and ketone bodies while providing both macro- and micronutrients to minimize the burden of fasting and adverse effects (72).
• Day 1 of the FMD supplies -4600 kJ (11% protein, 46% fat, 43% carbohydrate), whereas days 2-5 provide -3000 kJ (9% protein, 44% fat, 47% carbohydrate) per day.
• the FMD comprises proprietary formulations of vegetable-based soups, energy bars, energy drinks, chip snacks, tea, and a supplement providing high levels of minerals, vitamins and essential fatty acids (Fig. 7). All items to be consumed per day were individually boxed to allow the subjects to choose when to eat while avoiding accidentally consuming components of the following day.
• pre-post changes in markers within risk subgroups were tested using paired t-test; pre-post changes over risk subgroups were compared using two-sample t-test or analysis of variance.
• the FMD molecular and/or cellular fasting products and methods are enabled by precision-engineered nutrient profiles that sustain the body during fasting, and which are arranged to specifically prevent loss of lean muscle and bone mass, over fasting durations that may span several hours, a single day, a week, and during other periods of time.
• periodic and intermittent fasting may be accomplished by the FMD packages disclosed herein during single day fasts wherein a subject fasts for one day and then resumes normal feeding the next.
• Such intermittent fasting may utilize the disclosed FMD packages for “5-2” fasts wherein a subject eats normally for five days, then fasts for two days using the novel FMD packages of the disclosure (57).
• a refinement includes use of the new FMD packages during a single fast that alternates with normal eating a first day, followed by fasting the following, second day, and which is repeated for as subsequent days as may be desired or appropriate.
• the described FMD packages are used during single day intermittent fasts wherein eating occurs in a short window of time and fasting is accomplished over longer-periods.
• a subject engages in an “8-16” intermittent fast, and utilizes the contemplated FMD package to eat normally during a first, short, eight-hour window, while fasting during the second antecedent or subsequent 16-hour window of time, which occurs over a single day.
• Similar approaches utilize the disclosed one-day fast FMD packages herein for shorter 2, 4, 6, 10 and other eating time periods, and the longer 22, 20, 18, 14, and other fasting time periods (50, 51, 52).
• novel molecular cellular fasting, FMD products of this disclosure enable a subject to benefit from a single day fast and/or an intermittent fast accomplished during a 24-hour period of time.
• FMDs that incorporate such precision engineered products that have the predetermined nutrient profiles disclosed herein enable time-restricted and/or intermittent fasts over the 24-hour time period, as well as during fasts performed over hourly, daily, weekly, and other time periods (50, 51, 52).
• Such a precision engineered FMD-supplied profile of carbohydrates, protein, fats, and nutrients are precisely adjusted to predetermined ratios and levels. These ratios and levels as described in detail elsewhere herein are engineered to fall below the detection threshold of the nutrient sensors in the cells. This causes the cells of a subject to enter into a true fasting state that is nearly identical to when they are exposed to a water only, behavioral type of fast.
• the precise formulation of specific ratios and levels of carbohydrates, protein, fats, and nutrients establishes the precision engineered food constituents provided by the FMD and by the FMD portions and packages, which enables sustainable molecular and/or cellular fasting without detrimental consequences.
• An exemplary one-day fast diet package 200 includes multiple constituents and/or compositions, which may be grouped into meal portions, such as meal portions 205, 210, and/or 215 or others, which may be for example and without limitation be consumed at one time and together, or which may be consumed in meal portions that are spaced apart over time during a single day.
• meal portions may be grouped as a breakfast meal portion 205, a lunch meal portion 210, and/or a dinner meal portion 215 for consumption separately during the contemplated single day fast period of time.
• meal portions 205, 210, and 215 may incorporate discrete and sub-packaged meal items or components or constituents.
• meal portion 205 which may in one example be a breakfast meal portion, further includes a nut-containing nutrition bar composition 220, a micronutritional vegetable powder composition that incorporates vitamin and mineral supplements 225 (herein also sometimes referred to as an “NR-1” supplement), an algal oil composition 230, and other possible items such as teas or other constituents 235 and 240.
• NR-1 vitamin and mineral supplements
• meal portion 215, which may be a dinner meal portion will include a second soup composition 270, one of either the kale cracker composition 275 and/or an olive containing composition 280, a second nut-containing nutrition bar composition 285, and teas and other possibly predetermined items or constituents 290.
• Figures 17 through 26 further illustrate many various and interchangeable constituents and/or compositions, which may be utilized in the contemplated one-day fast diet package, and which may be grouped into meal portions as described further below.
• Participant enrollment and participation for this one-day fast diet package study was prepared informally for initial analyses. Subjects were recruited and participated during November, 2021 with an informal protocol based on inclusion of four males and four females that are generally healthy, 31 to 56 years of age, and generally known to be without any major medical condition or chronic diseases, mental illness, drug dependency, hormone replacement therapy [DHEA, estrogen, thyroid, testosterone], pregnant or nursing female, special dietary requirements or food allergies, alcohol dependency, or medications known to affect body weight.
• DHEA hormone replacement therapy
• DHEA estrogen, thyroid, testosterone
• pregnant or nursing female special dietary requirements or food allergies, alcohol dependency, or medications known to affect body weight.
• Pre-specified outcome measures during the one-day fast and consumption of the contemplated diet package compositions included only blood glucose and ketone testing. This testing was accomplished with consumer test equipment that included a Precision Xtra(R) Blood Glucose & Ketone Monitoring System, available from Abbott at https://abbott.com as SKU or product number 9881465. Each glucose and ketone test utilized this equipment and corresponding blood ketone and glucose test strips that are compatible for use with the Precision Xtra(r) System. Five test data points were recorded for each participant over a one-day fast test period of time spanning 24 hours. The recorded test data is reflected in Figure 27, which is described in more detail below.
• the participants were instructed to consume the one-day fast FMD meal portions at predetermined times, and no other foods during the 24 hour period of the one-day fast.
• the one- day fast FMD package was provided with meal portions that grouped the FMD package constituents into three meal portions, one each for breakfast, lunch, and dinner.
• the one-day FMD is a plant-based diet designed, among other benefits, to attain fasting-like effects on the serum levels of IGF-1, IGFBP1, glucose and ketone bodies while providing both macro- and micronutrients that minimize the burden and discomfort of fasting, as well as possible adverse effects (72).
• Compositions of the package are portioned as described herein, and in the accompanying figures, to attain fasting-like effects on serum levels of IGF-1, IGFBL1, glucose, and ketone bodies while providing both macronutrients and micronutrients to minimize the burden of fasting and adverse effects, and without starvation of the subject.
• the one-day FMD package comprises proprietary formulations of vegetable-based soups, energy bars, energy drinks, chip snacks, tea, and a supplement providing high levels of minerals, vitamins and essential fatty acids, which items or constituents are described in Figures 17A-17G, 18, 19, 20, 21 A-21I, and 22 through 26. All items to be consumed during the one day fast per day were discretely portioned and packaged according to the depictions in these noted figures, and grouped into the respective breakfast, lunch, and dinner meal portions as reflected in Figure 16 and as described in one exemplary arrangement shown below in the “One-Day FMD Meal Schedule” Tables A and B.
• ketone blood levels beneficially but unexpectedly increased for each participant, while their glucose blood levels decreased. More specifically, it was observed that the average ketone blood level of all participants evidenced ketogenic effects, and increased from 0.2 mM to 0.5 mM over the duration of the 24-hour, one-day fasting period. The average glucose level of all participants decreased from about 85 mg/dL to as low as about 75 mg/dL, while returning to only about 78 mg/dL at the end of the 24-hour fast.
• one arrangement of a fasting mimicking diet package 200 includes breakfast 205, lunch 210, and dinner 215 meal portions for a one-day fast.
• An exemplary breakfast meal portion 205 includes a first nut-containing nutrition bar composition 220 (see, e.g., any of those described in Figs. 17A-17G), a micronutritional vegetable powder composition 225 including vitamin and mineral supplements (see, e.g., Fig. 18), and an algal oil composition 230 (see, e.g., Fig. 19).
• An example lunch meal portion 210 includes a first soup composition 245 (see, e.g., one of those reflected in Figs. 21 A-21I) and a kale cracker composition 250 (see, e.g., Fig. 20).
• An illustrative dinner meal portion 215 includes a second soup composition 270 (see, e.g., any of those described in Figs. 17A-17G), one of either the kale cracker composition 275 (see, e.g., Fig. 20) or an olive containing composition 280 (see, e.g., one of those of Figs. 22 and 23), and a second nut-containing nutrition bar composition 285 (also see, e.g., one of those of Figs. 17A-17G).
• a modified FMD package 200 (Fig. 16) also includes tea compositions (see, e.g. Fig. 24) that each include at least one of lemon, hibiscus, and spearmint tea, and combinations thereof and others, which may be consumed any time during the 24-hour period of the one-day fast.
• tea compositions such as those of Fig. 24 may be consumed as a breakfast item 235, 240, a lunch item 255, 260, and 265, and a dinner item 290.
• energy drinks may be consumed as a different breakfast constituent 235, 240, lunch item 255 - 265, or dinner constituent 290.
• first nut-containing nutrition bar 220 containing almonds, macadamias, and pecans with predetermined nutrition profiles of fat, carbohydrates, and proteins (Figs. 17A and 17C-17G), and/or the algal oil composition having a nutrition profile that includes DHA Omega-3 fatty acid and optionally at least one of aurantiochytrium and schizocatrium algae oil (Fig. 19).
• the FMD diet package 200 in other adaptations incorporates the second nut-containing nutrition bar composition 270 having a nutrition profiles that includes inulin, almonds, almond butter, brown rice crispy, cocoa powder, chocolate chips, rolled oats, flaxseed oil, rice dextrin, grape juice, and salt (see, e.g., Fig. 17B).
• the second nut-containing nutrition bar composition 270 is sized with a portion size that is half of the first nut-containing nutrition bar and includes almonds, macadamias, pecans, honey, flaxseed, coconut flour, and rosemary extract (see, e.g., Fig. 17A).
• the nut-containing nutrition bars may optionally contain almonds, macadamias, and pecans and may in other modifications contain honey, flaxseed, coconut flour, and rosemary extract (see, e.g., Figs. 17A and 17C-17G).
• nut-containing nutrition bars 270 containing almonds, macadamias, and pecans, and/or one or more of chicory root fiber, tocopherols, acai, blueberries, cacao nibs, cocoa powder, raspberries, strawberries, and lemon juice (see, e.g., Figs. 17A and 17C- 17G).
• the first and second FMD nut-containing nutrition bar compositions 220, 285 are formulated to provide from about 90 kcal to about 350 kcal per serving, or between about 90 kcal and 260 kcal per serving (see, e.g., Figs. 17A, 17B), or optimally between about 200 kcal and 210 kcal per serving (see, e.g., Figs. 17C - 17G).
• the first and second FMD nutrition bar compositions are precisely formulated to provide about 10 grams to about 35 grams of total fat per serving, and in variations between about 5 grams and 22 grams of total fat per serving.
• the first and second FMD nutrition bars are formulated to provide less than about 20 grams of saturated fat per serving and optionally, less than about 5 grams of trans-unsaturated fatty acids (hereafter “trans fat”) (optimally, less than 1 gram of trans fat). Further modifications contemplate the first and second FMD nutrition bars having between about 17 grams and 18 grams of total fat per serving.
• first and second FMD nutcontaining nutrition bar compositions having no trans fat, and saturated fat of between about one gram and four grams per serving, and more preferably between about two grams and 3.5 grams per serving. Further modification contemplate each of the first and second nut-containing nutrition bar compositions containing polyunsaturated fat ranging between about 2.5 grams and about 3.5 grams, and monounsaturated fat between about 9 grams and about 11 grams.
• each of the first and second FMD nutrition bar compositions is formulated to provide less than about 10 grams of protein per serving.
• the first and second FMD nutrition bar compositions are precisely formulated to provide from about one to about 8 grams of protein per serving.
• the first and second FMD nutcontaining nutrition bar compositions are formulated to provide between about 2 grams and 6 grams of protein per serving, or between about 4 grams and 5 grams of protein per serving.
• each of the first and second FMD nut-containing nutrition bar composition is precisely formulated to provide less than about 30 grams of carbohydrates per serving.
• these nutrition bar compositions are formulated to provide between about 8 grams and about 25 grams of carbohydrates per serving.
• the first and second FMD nutrition bar compositions are each formulated to provide from about 10 to 18 grams of carbohydrates per serving. 01861 Still other modifications contemplate each FMD nut-containing nutrition bar composition having between about 13 grams and about 14 grams of total carbohydrates per serving. Other arrangements of the first and second FMD nutrition bar compositions provide total sugar between about 3 grams and about 9 grams, or about 5 grams of total sugar per serving. In any of these variations, the first and second FMD nut-containing nutrition bar compositions are precisely formulated to have between about one gram and about 7 grams, or at most about 3 grams of added sugar per serving.
• the first and second FMD nutrition bar compositions can be formulated within these limits with any combination of macadamia nuts, honey, pecans, almonds, almond butter, coconut flour, sea salt, mixed tocopherols (vitamin E), citric acid, and ascorbic acid.
• the first and second nut-containing nutrition bar compositions being precisely formulated within these limits with any combination of inulin, almond butter, brown rice crispy, cocoa powder, almonds, chocolate chips (cane sugar, unsweetened chocolate, cocoa butter), rolled oats, brown rice syrup, flaxseed oil, rice dextrin, grape juice, and salt.
• the one-day fast FMD packages 200 also include the micronutritional vegetable powder with vitamin and mineral supplements composition 225 containing Vit A, Vit C, Ca, Fe, Vit D3, Vit E, Vit K, Vit Bl, Vit B2, Vit B3, Vit B5, Vit B6, Vit B7, Vit B9, Vit B12, Cr, Cu, I, Mg, Mn, Mo, Se, and Zn (see, e.g., Fig. 18).
• the micronutritional vegetable powder with vitamin and mineral supplements composition 225 contains ascorbic acid, beet root powder, beta carotene, calcium carbonate, carrots, cholecaliciferol, chromium picolinate, collard leaf powder, cupric sulfate, cyanocobalamin, Dialpha tocopherol acetate, ferrous fumarate, folic acid, kale leaf, magnesium stearate, manganese sulfate, niacinamide, pantothenic acid, phytonadione, potassium iodine, pyriodoxine HC1, riboflavin, sodium molybdate, sodium selenate, spinach, thiamine mononitrate, tomatoes, tribasic calcium phosphate, and zinc oxide (Fig. 18).
• ascorbic acid beet root powder
• beta carotene calcium carbonate
• carrots cholecaliciferol
• chromium picolinate collard leaf powder
• the micronutritional vegetable powder with vitamin and mineral supplements composition 225 also otherwise may include, for further example, Vit A, Vit C, Vit D, Vit E, Vit KI, Vit Bl, Vit B2, Vit B3, Vit B6, Vit Bl 2, folic acid, biotin, pantothenic acid, calcium, iron, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, kale leaves, beet root, carrot root, spinach leaves, and tomato (Fig. 18).
• Any of the one-day fast FMD packages 200 also are arranged to have the kale cracker composition 250 to include almonds, kale, sesame seeds, and tapioca flour, and/or almonds, kale, sesame seeds, tapioca flour, chia seeds, flax seeds, sunflower oil, salt, coconut sugar and vinegar, onion, chili pepper, cumin seed, black pepper, garlic, tocopherols, oregano, and citric acid (see, e.g., Fig. 20).
• each FMD soup composition such as for example soup compositions 245 and 270, is formulated to provide from about 80 kcal to 150 kcal per serving, and optionally between about 110 kcal and 120 kcal (see, e.g. Figs. 21 A - 211).
• “provide” also means “contains” and “includes.”
• each FMD soup is formulated to provide about 1 to 5 grams of total fat per serving, and optionally between about 1.5 grams and 2.5 grams of total fat per serving.
• each FMD soup is formulated to provide less than about one gram of saturated fat per serving and less than about 5 grams of trans fat (optimally, less than one gram of trans fat). Modifications include such FMD soups to have substantially no saturated or trans fat.
• each FMD soup composition is precisely formulated to provide less than about 10 grams of protein per serving.
• each FMD soup is formulated to provide from about 1 to 8 grams of protein per serving.
• each FMD soup is formulated to provide from about 2 to 6 grams of protein per serving, and optimally between about 2 and 5 grams of protein per serving.
• each FMD soup is precision formulated to provide less than about 40 grams of carbohydrates per serving. In a further refinement, each FMD soup is formulated to provide from about 10 to 35 grams of carbohydrates per serving. In still another variation, each FMD soup is formulated to provide from about 20 to 30 grams, and more preferably between about 22 and 25 grams of carbohydrates per serving. In any of the contemplated precision engineered FMD soup formulations, further modifications are directed to carbohydrate total sugar content limited to between about 1 and 4 grams per serving, and optimally substantially no added sugars.
• the FMD soups can be formulated within these exemplary limits from any combination of components selected from the group consisting of black beans, butternut squash, quinoa, tomatoes, mushrooms, white beans (e.g., great northern beans), brown beans, spinach, green tea extract, rice flour, onions, brown rice powder, carrots, inulin, leeks, olive oil, cabbage, potatoes, olives, peas, pumpkin, maltodextrin, and celery, chicory root fiber, sea salt, yeast, basil, parsley, garlic, rosemary extract, coriander, oregano, potato starch, potato flakes, zucchini squash, turmeric.
• the FMD soups can also be precisely formulated within these limits from a first component selected from the group consisting of black beans, butternut squash, quinoa, tomatoes, mushrooms, white beans (e.g., great northern beans), brown beans, spinach, and combinations thereof and a second component selected from the group consisting of green tea extract, rice flour, onions, brown rice powder, carrots, inulin, leeks, olive oil, cabbage, potatoes, olives, peas, pumpkin, maltodextrin, and celery, chicory root fiber, sea salt, yeast, basil, parsley, garlic, rosemary extract, coriander, oregano, potato starch, potato flakes, zucchini squash, turmeric, and combinations thereof.
• the FMD soups are provided as a powder that can be combined with water to form the soup, typically, with heating.
• Exemplary FMD soups include for example without limitation, vegetable soups, quinoa-containing minestrone soups, mushroom-containing soup, tomato-containing soup composition, bean-containing minestrone soup composition, pumpkin soup composition, white bean and spinach soup, back bean soup, butternut squash soup, butternut squash and quinoa soup, and a vegetable broth.
• a vegetable soup composition includes onions, tomatoes, spinach, green tree extract, optionally rice flour, optionally brown rice powder, optionally carrots, leeks, and optionally inulin.
• An example of a quinoa-containing minestrone soup composition includes quinoa, green tea extract, optionally olive oil, optionally cabbage, optionally potatoes, optionally rice flour, and optionally tomatoes and optionally no turmeric.
• a vegetable soup composition example includes carrots, inulin, leeks, onions and rice flour.
• a specific example of a mushroom-containing soup composition includes mushrooms, green tea extract, optionally brown rice powder, optionally carrots, and optionally inulin.
• a specific example of a mushroom-containing soup composition includes carrots, inulin, mushrooms, onions, and rice flour.
• a tomato-containing soup composition includes tomatoes, green tea extract, optionally inulin, and optionally onions.
• a different tomato-containing soup example composition includes tomatoes, inulin, olives, onions, potatoes, and rice flour.
• a specific example of a quinoa-containing minestrone soup composition includes quinoa, green tea extract, optionally olive oil, optionally cabbage, optionally potatoes, optionally rice flour, and optionally tomatoes and optionally no turmeric.
• a refinement of a quinoa-containing minestrone soup composition contains quinoa, green tea extract, optionally olive oil, optionally cabbage, and optionally potatoes, optionally rice flour, and optionally tomatoes and optionally no turmeric.
• An exemplary bean-containing minestrone soup composition includes white beans (e.g., great northern beans), great tea extract, optionally cabbage, and optionally potatoes.
• the bean-containing minestrone soup composition includes brown beans, carrots, peas, potato, and rice flour.
• An example of a pumpkin soup composition includes pumpkin, green tree extract, optionally rice flour, optionally carrots, and optionally brown rice powder.
• a specific example of a first vegetable broth includes carrots, maltodextrin, celery, spinach, and tomatoes.
• Another example of a vegetable broth includes carrots, maltodextrin, celery, spinach, and tomatoes.
• a white bean and spinach soup exemplary composition includes white beans, whole grain brown rice, rice flour, chicory root fiber, olive oil, spinach leaves, sea salt, celery, onion, yeast extract, and garlic.
• a specific example of a black bean soup composition includes black beans, chicory root fiber, whole grain brown rice, olive oil, potato starch, rosemary extract, sea salt, onion, yeast extract, garlic, coriander, and oregano.
• a specific example of a butternut squash composition includes butternut squash, rice flour, whole grain brown rice, chicory root fiber, sea salt, carrots, olive oil, potato starch, rosemary extract, onion, and yeast extract.
• a specific example of a butternut squash and quinoa composition includes butternut squash, quinoa, whole grain brown rice, rice flour, chicory root fiber, olive oil, potato starch, rosemary extract, sea salt, onion, yeast extract, garlic, and chives.
• first and second soup compositions to each include at least rice flour, chicory root fiber, onion, olive oil, and yeast extract.
• These modifications may also otherwise include the first and second soup compositions 245, 270 to incorporate rice flour, chicory root fiber, onion, olive oil, salt, and yeast extract, and/or one or more of basil, parsley, whole grain brown rice, sweet red peppers, leeks, spinach, cabbage, tomato, celery, turmeric, quinoa, potato flakes, peas, carrots, zucchini squash, broccoli, celery seeds, mushroom powder, white beans, black beans, garlic, coriander, oregano, butternut squash, and chives.
• first and second soup compositions in modified variations will each include rice flour, chicory root fiber, onion, olive oil, salt, and yeast extract, and wherein each of the first and second soup compositions incorporates one of
• butternut squash soup constituents that include whole grain brown rice, carrots, butternut squash, and chives
• butternut squash and quinoa soup constituents that include whole grain brown rice, quinoa, butternut squash, garlic, and chives.
• Each or any of the various arrangements of prior-described multi-day FMD packages 10, as well as the contemplated one-day fast FMD packages 200 further may be adapted wherein the combination of the breakfast, lunch, and dinner meal portions provide in total 75% or less of a daily recommended caloric intake for a subject.
• the combination of the breakfast, lunch, and dinner meal portions provide 50% or less of a daily recommended caloric intake for a subject.
• Further exemplary modifications are directed to the combination of the breakfast, lunch, and dinner meal portions providing 25% or less of a daily recommended caloric intake for a subject.
• the one-day fast FMD package 200 is precisely formulated to provide between about 500 kcal and about 1500 kcal per package over the aggregate of the meal plan schedules and meal portions described herein. Further variations are directed to the one-day fast FMD package 200 formulated precisely to contain between about 740 kcal and about 1140 kcal in aggregate per package. Modifications also include the one-day fast FMD package 200 precision engineered to have between 910 kcal and 945 kcal per package and in aggregate of the meal portions incorporated therein. Each of the many contemplated variations of formulations are contemplated for use with the various types of intermittent fasting and/or time-restricted fasting using the contemplated one-day FMD packages 200 described herein.
• one-day fast FMD packages or prior-described FMD packages include the combination of the breakfast, lunch, and dinner meal portions provide per package 200 and in aggregate at least about 50 grams of fat or at least about 30 grams of fat, carbohydrates including less than about 20 grams of sugar, and at least about 20 grams of protein. Variations are also contemplated wherein the combination of the breakfast, lunch, and dinner meal portions per package 200 provide in aggregate between about 50 grams and about 60 grams of fat, carbohydrates including between about 10 grams and about 20 grams of sugar, and between about 20 grams and about 30 grams of protein. Still other modifications include the combination of the breakfast, lunch, and dinner meal portions adapted to provide less than about 60 grams of fat, carbohydrates including less than about 20 grams of sugar, and less than about 30 grams of protein.
• Combinations of the breakfast, lunch, and dinner meal portions also contemplate providing between 70% and 80% of a daily recommended fat intake for a subject, between 25% and 40% of a daily recommended sugar intake for the subject, and between 25 grams and 30 grams of protein.
• Modified versions of the one-day fast FMD package 200 may have the combination of the breakfast, lunch, and dinner meal portions formulated as described herein to provide less than 80% of a daily recommended fat intake for a subject, less than 40% of a daily recommended sugar intake for the subject, and less than about 30 grams of protein.
• the one-day fast FMD package and constituent combination of the breakfast, lunch, and dinner meal portions 205, 210, 215 are consumed by a subject for only one day per week for at least 30 days, or four weeks, or a month, and for one-day per week over longer periods of time.
• the one-day-fast FMD packages 200 are consumed by a subject that fast intermittently and/or restricts eating to certain time periods while fasting before and after such FMD eating time periods.
• Other variations include the subject consuming the one- day fast FMD package 200 during two days per week, while eating normally during the preceding and/or subsequent 5 days of the week, which is sometimes referred to as a 5-2 fast (57).
• each of the various FMD packages including the one-day fast FMD package, also contemplate various methods of use as described in more detail elsewhere herein.
• the FMD can also modified to be a low sodium diet that provides less than 1000 mg of sodium chloride per day.
• the one-day fast FMD package may be utilized for a method for inducing differential effects on disease factors and markers associated with aging, which includes administering the one-day fast FMD package to a subject.
• the disease factors and marking are and/or may be insulin-like growth factor-1, blood glucose, systolic blood pressure, diastolic blood pressure cholesterol, CRP, triglycerides, or abdominal/visceral fats.
• the method includes administering one of the exemplary, one-day fast FMD packages to a subject in need thereof. Also contemplated herein is a method of using the one-day fast FMD packages wherein the stem-cell based regeneration of multiple organs and systems includes neurogenesis, hematopoiesis, or promotion of pancreatic beta-cells.
• While exemplary embodiments are described above, it is not intended that these embodiments describe all possible forms of the invention. Rather, the words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention. Additionally, the features of various implementing embodiments may be combined to form further embodiments of the invention.
• Ketogenic diet improves metabolic syndrome in multiple ways, https://www.diabetes.co.uk/news/2017/dec/ketogenic-diet-improves-metabolic- syndrome-in-multiple-ways-99064712.html, (18 December 2017). Victoria M.Gershuni, Stephanie L. Yan, Valentina Medici, "Nutritional Ketosis for Weight Management and Reversal of Metabolic Syndrome". Current Nutrition Reports. 7 (3): 97-106. (20 August 2018)/ K. G.
• M. S. Bonkowski et al. Disruption of growth hormone receptor prevents calorie restriction from improving insulin action and longevity. PloS one 4, e4567 (2009).
• M. E. Levine et al. Low protein intake is associated with a major reduction in 1GF-1, cancer, and overall mortality in the 65 and younger but not older population. Cell metabolism 19, 407 (Mar 4, 2014).
• J. Guevara-Aguirre et al. Growth hormone receptor deficiency is associated with a major reduction in pro-aging signaling, cancer, and diabetes in humans. Sci Transl Med 3, 70ral3 (Feb 16, 2011).
• M. W. Gillman Developmental origins of health and disease.
• Florakis et al. Effect of hypocaloric diet plus sibutramine treatment on hormonal and metabolic features in overweight and obese women with polycystic ovary syndrome: a randomized, 24-week study. International journal of obesity 32, 692 (Apr, 2008). M. Harvie etal., The effect of intermittent energy and carbohydrate restriction v. daily energy restriction on weight loss and metabolic disease risk markers in overweight women. The British journal of nutrition 110, 1534 (Oct, 2013).
• G. Brabant et al. Serum insulin-like growth factor 1 reference values for an automated chemiluminescence immunoassay system: results from a multicenter study. Hormone research 60, 53 (2003). ww.census.gov C.
• Patikorn et al. Intermittent Fasting and Obesity-Related Health Outcomes, An Umbrella Review of Meta-analyses of Randomized Clinical Trials. JAMA Network Open 2021;4(12:e2139558 (December 17, 2021).
• P. Hajek et al. A Randomized Controlled Trial of the 5:2 Diet. PLOS ONE16(ll):e0258853 (November 17, 2021).
• R. Schubel et al. Effects of intermittent and continuous calorie restriction on body weight and metabolism over 50 wk: a randomized controlled trial.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Natural Medicines & Medicinal Plants (AREA)
• Chemical & Material Sciences (AREA)
• Veterinary Medicine (AREA)
• Epidemiology (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Medicinal Chemistry (AREA)
• Animal Behavior & Ethology (AREA)
• Pharmacology & Pharmacy (AREA)
• Engineering & Computer Science (AREA)
• Mycology (AREA)
• Botany (AREA)
• Medical Informatics (AREA)
• Biotechnology (AREA)
• Alternative & Traditional Medicine (AREA)
• Microbiology (AREA)
• Nutrition Science (AREA)
• Food Science & Technology (AREA)
• Polymers & Plastics (AREA)
• Molecular Biology (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Coloring Foods And Improving Nutritive Qualities (AREA)
• Seeds, Soups, And Other Foods (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Medicines Containing Plant Substances (AREA)
• Grain Derivatives (AREA)
• Bakery Products And Manufacturing Methods Therefor (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
• Medicines Containing Material From Animals Or Micro-Organisms (AREA)
• Tea And Coffee (AREA)

Applications Claiming Priority (2)

Publications (2)

Family

ID=87000359

Family Applications (1)

Country Status (7)

Family Cites Families (9)

• 2022
  • 2022-12-30 EP EP22917605.2A patent/EP4456741A4/de active Pending
  • 2022-12-30 WO PCT/US2022/082623 patent/WO2023130071A1/en not_active Ceased
  • 2022-12-30 JP JP2024539937A patent/JP2024545796A/ja active Pending
  • 2022-12-30 CA CA3241956A patent/CA3241956A1/en active Pending
  • 2022-12-30 MX MX2024008268A patent/MX2024008268A/es unknown
  • 2022-12-30 AU AU2022425633A patent/AU2022425633A1/en active Pending
  • 2022-12-30 CN CN202280092094.2A patent/CN118973410A/zh active Pending

Also Published As

Similar Documents

Legal Events