WO2013144267A2 - Amélioration de la santé musculosquelettique par nutrition et exercice - Google Patents

Amélioration de la santé musculosquelettique par nutrition et exercice Download PDF

Info

Publication number
WO2013144267A2
WO2013144267A2 PCT/EP2013/056645 EP2013056645W WO2013144267A2 WO 2013144267 A2 WO2013144267 A2 WO 2013144267A2 EP 2013056645 W EP2013056645 W EP 2013056645W WO 2013144267 A2 WO2013144267 A2 WO 2013144267A2
Authority
WO
WIPO (PCT)
Prior art keywords
composition
exercise
child
physical
subject
Prior art date
Application number
PCT/EP2013/056645
Other languages
English (en)
Other versions
WO2013144267A3 (fr
Inventor
Martinas Kuslys
Douglas Richard Bolster
Original Assignee
Nestec S.A.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nestec S.A. filed Critical Nestec S.A.
Publication of WO2013144267A2 publication Critical patent/WO2013144267A2/fr
Publication of WO2013144267A3 publication Critical patent/WO2013144267A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/19—Dairy proteins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • 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 COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention relates to a composition, to a composition in combination with physical exercise for supporting growth of a subject, in particular of a child with compromised health.
  • the invention further relates to uses and methods for supporting growth, of improving musculoskeletal health, and for obtaining further beneficial effects as reported in this specification.
  • body composition such as body mass index, lean body mass, muscle mass, reduce fat portion in the body, and the like.
  • An objective of the present invention is to provide nutrition, and in particular to provide nutrition that is suitable to support healthy growth.
  • the invention has the objective of providing nutrients, phytonutrients, antioxidents, vitamins and minerals that support a healthy growth even in subjects, in particular children, having impaired absorption of nutrients in the gastro -intestinal tract, subjects suffering from malnutrition of any kind and origin, and subjects that are weakened due to disease, and other subjects having a compromised health status.
  • the invention is based on the finding that certain subjects, such as children having compromised health, do not sufficiently engage in physical activity, thereby negatively influencing the parameters that are necessary for healthy growth.
  • the present invention has in particular the goal of disrupting the vicious circle that emerges in subjects with fragile health status and/or malnutrition. These subjects naturally reduce or completely avoid physical activity and/or exercises, partly due to lacking motivation and lack of energy, thereby further reducing their body's capacity to cope with reduced health and/or disease.
  • the present invention concerns a composition comprising one or more nutrients.
  • the composition is suitable to achieve one or more beneficial effects in a subject, such as health effects, therapeutic effects and prophylactic effects, for example.
  • the beneficial effects reported herein are generally referred to as "effects" or "effect”.
  • the invention provides a combination of the composition of the invention and physical exercise for obtaining said effects in the subject.
  • the invention provides a nutrition- and exercise-based treatment and/or program for obtaining the effects of the invention.
  • the effects obtained in accordance with the invention encompass an increase of life quality in general. Life quality is improved, according to an embodiment, by way of the further beneficial effects reported herein. Accordingly, an effect of the invention is that the invention improves well-being of a subject. A further effect of the invention is the improvement of health in general of a subject. An effect of the invention is that the invention ensures and/or supports growth in a subject, in particular a subject that is growing and/or not yet grown-up. An effect of the invention is the improvement and/or support of musculoskeletal health. An effect of the invention is the improvement and/or support of the status and/or integrity of the musculoskeletal system.
  • An effect of the invention is to increase muscle and/or bone mass and/or formation.
  • An effect of the invention is to increase muscle and/or bone accretion.
  • An effect of the invention is the increase of one or more selected from muscle strength, muscle power, local muscle endurance and combinations thereof.
  • An effect of the invention is the increase of one or more selected from bone health, bone density, bone strength, and/or combinations thereof.
  • An effect of the invention is that it increases lean body mass.
  • An effect of the invention is the reduction of the incidence of bone fracture and/or reducing the risk of bone fractures.
  • An effect of the invention is the enhancement of motor skill performance.
  • the invention further has the effect of increasing bone mineral density and/or bone mineral content.
  • a further effect of the invention is the improvement of the body composition.
  • a further effect of the invention is the improvement of insulin sensitivity.
  • a further effect is that the invention improves the blood or serum lipid profile.
  • the invention is suitable to achieve one or a combination of two or more of these effects.
  • the reference to an "effect of the invention” or the “effects of the invention” refers to one or a combination of two or more or to all these effects and other effects reported elsewhere in this specification.
  • the effects of the invention are obtained in a subject.
  • the subject is a growing subject, in particular a child.
  • the invention is directed to subjects, in particular children having compromised health. Further indications with respect to the subject in which the effects of the invention are obtained are set forth elsewhere in this specification and in particular in the detailed description of the preferred embodiments.
  • the present invention provides a composition comprising one or more nutrients for obtaining any one or more of the effects of the invention.
  • the present invention provides a composition comprising one or more nutrients and physical exercise for obtaining any one or more of the effects of the invention.
  • the present invention provides a composition comprising one or more nutrients in a treatment for obtaining any one or more of the effects of the invention, said treatment further comprising physical exercise.
  • the invention provides a treatment comprising (1) administration of nutrients and/or of a composition comprising nutrients and (2) physical exercise for obtaining any one or more of the effects of the invention.
  • the present invention provides a composition comprising nutrients for increasing any one of the physical-exercise supported and/or stimulated effects of the invention.
  • the present invention provides a composition comprising nutrients for increasing the effects of the invention produced by physical exercise.
  • the present invention provides a composition comprising nutrients for obtaining the effects of the invention between periods of physical exercise.
  • the present invention provides a composition comprising nutrients for the preservation of the effects of the invention in a subject between periods of physical exercise.
  • the invention provides a method for obtaining any one or more of the effects of the invention, the method comprising the steps of administrating a composition comprising nutrients.
  • the invention provides a method for obtaining any one or more of the effects of the invention, the method comprising the steps of administrating a composition comprising nutrients and conducting physical exercise.
  • the invention provides a method for obtaining any one or more of the effects of the invention, the method comprising the steps of administrating a composition comprising nutrients and prescribing and/or recommending physical exercise.
  • the invention provides a method for obtaining any one or more of the physical exercise-supported and/or stimulated effects of the invention, the method comprising the step of administrating a composition comprising nutrients to a subject.
  • the invention provides a method for increasing any one or more of the effects of the invention produced by physical exercise, the method comprising the step of administrating the composition of the invention.
  • the invention provides a method for obtaining any one or more of the effects of the invention, the method comprising the step of administrating the composition comprising nutrients to a subject undergoing physical exercise.
  • the invention provides a method for obtaining any one or more of the effects of the invention, the method comprising the step of administrating the composition of the invention between periods of physical exercise by a subject.
  • the invention provides a method for preserving any one or more of the effects of the invention between periods of physical exercise, the method comprising the step of administrating a composition comprising nutrients by a subject.
  • the present invention provides a composition comprising one or more nutrients and physical exercise for improving life quality and/or supporting growth.
  • the present invention provides a composition comprising one or more nutrients in a treatment for improving life quality and/or supporting growth, said treatment further comprising physical exercise.
  • the invention provides a method for improving life quality and/or supporting growth, the method comprising the steps of administrating a composition comprising nutrients and conducting physical exercise.
  • the present invention provides a composition comprising one or more nutrients and physical exercise for improving musculoskeletal state and/or health.
  • the present invention provides a composition comprising one or more nutrients in a treatment for improving musculoskeletal state and/or health, said treatment further comprising physical exercise.
  • the invention provides a method for improving musculoskeletal state and/or health, the method comprising the steps of administrating a composition comprising nutrients and conducting physical exercise.
  • the present invention provides a composition comprising one or more nutrients and physical exercise for increasing one or more selected from the group of muscle strength, muscle power, muscle endurance, and combinations thereof and/or one or more selected from the group of bone health, bone strength, bone density, bone mineral content and/or density, and combinations thereof.
  • the present invention provides a composition comprising one or more nutrients in a treatment for increasing one or more selected from the group of muscle strength, muscle power, muscle endurance, and combinations thereof and/or one or more selected from the group of bone health, bone strength, bone density, bone mineral content and/or density, and combinations thereof, said treatment further comprising physical exercise.
  • the present invention provides a composition a comprising one or more nutrients in a treatment for improving the musculoskeletal state in a child having a fragile health status and/or compromised health, said treatment further comprising physical exercise.
  • the invention provides a composition and/or a method for increasing one or more selected from the group of muscle strength, muscle power, muscle endurance, and combinations thereof and/or one or more selected from the group of bone health, bone strength, bone density and combinations thereof.
  • said child is suffering from Crohn's disease, cystic fibrosis (CF), irritable bowel syndrome, allergy, and/or asthma, in particular chronic allergy.
  • CF cystic fibrosis
  • said physical exercise may involve the use of electronically-assisted and/or computer-assisted games.
  • the subject is a subject having compromised health and/or a fragile health status, in particular children having compromised health and/or a fragile health status.
  • the subject is preferably a pediatric patient.
  • the subject, in particular the child is suffering from suboptimal nutrition and/or malnutrition.
  • the subject, in particular the child is selected from subjects suffering from Crohn's disease, cystic fibrosis (CF), inflammatory bowel disorders, and/or subjects suffering from asthma and/or allergy.
  • CF cystic fibrosis
  • the purpose or effect of the invention is to reduce and/or prevent deficiencies and/or deficiency symptoms in subjects having reduced absorption and/or absorption capacities, in particular reduced capacity of nutrient, for example mineral absorption capacities.
  • absorption and/or absorption capacities refer, in particular, to absorption in the gastro-intestinal tract, in particular in the intestines, for example the small and/or large intestine.
  • a subject the capacity of a subject's gastro-intestinal tract to absorb one or more specific nutrients (in particular micronutrients) is compromised. This may lead to a lack or deficiency of the respective nutrient in the body of the subject.
  • the invention is particularly adapted to children, the invention may also be used in non-human subjects.
  • the subject is an animal, for example a mammal.
  • the subject is selected from livestock and/or pet animals, such as cattle, including cows, goats, sheep, but also pigs, camels, or poultry animals, for example.
  • composition of the invention may be a pharmaceutical composition. It may be provided in the form of tablets, pills, capsules, for example gelatine capsules, effervescent tablets, and the like, for example.
  • the composition of the invention is nutritionally complete, but may be used in combination with other and/ normal food, as a supplement.
  • the nutritionally complete formula may be consumed in combination with other food, thus as to contribute to anything from 5-100%, for example 10-100%, preferably 20-100%, 40-100%, 50-100%, and/or 70-100%) of the caloric needs of the subject.
  • the composition comprises at least one nutrient.
  • Nutrients may be selected from macronutrients (proteinogenic matter, available carbohydrates and lipids, in particular oils and/or fats), and from micronutrients, such as vitamins and minerals.
  • the invention comprises selected macro- and micronutrients.
  • the composition comprises one or more phytonutrients and/or antioxidants.
  • phytonutrients include flavonoids such as quercetin, curcuminoids such as curcumin and limonin.
  • Antioxidants are molecules capable of slowing or preventing the oxidation of other molecules.
  • Non-limiting examples of antioxidants include vitamin A, carotenoids, vitamin C, vitamin E, selenium, flavonoids, lactowolfberry, wolfberry, polyphenols, lycopene, lutein, lignan, coenzyme Q10 ("CoQIO”), hesperidine and glutathione.
  • Preferred components selected from macronutrients, micronutrients (vitamins and/or minerals), nucleotides, antioxidants and/or phytonutrients that may be used in the composition in accordance with the present invention, and/or preferred amounts of such components, are discussed in further detail elsewhere in this specification.
  • the composition of the invention comprises proteinogenic matter.
  • a source of protein for the purpose of the present specification, the expressions "a source of protein”, “protein” and “a source of proteinogenic matter” and “proteinogenic matter” in general encompass any proteinogenic matter. These expressions thus encompass proteinogenic amino acids, in particular free amino acids, dipeptides, oligopeptides, polypeptides, proteins, and the like, and mixtures of the aforementioned.
  • the expression "source of protein” also encompasses protein hydrolysates, for example.
  • the composition comprises milk protein or a milk protein hydrolysate and free amino acids, for example whey protein as disclosed elsewhere in this specification and free amino acids.
  • the nutritional composition comprises proteinogenic matter originating from milk protein.
  • Milk protein may be obtained from any animal mammalian species, such as cattle, for example cows, buffalos, sheep, goats, but also from horses and camels, for example.
  • the composition of the invention comprises milk protein.
  • the composition may comprise any one selected from casein, casein hydrolysates, casemates, whey, whey hydrolysates, milk protein concentrate, milk protein isolate, and combinations thereof.
  • the composition comprises casein and/or whey, for example intact and/or hydro lysed casein and/or whey.
  • the composition comprises casein.
  • casein For example hydrolyzed casein may be used.
  • the composition comprises casein comprising active TGF-P2.
  • the composition comprises from 0.2 to 10 ⁇ g, preferably 0.5 to 2 ⁇ g TGF-P2 per g of casein.
  • the TGF-P2 may be in a form that can be/is activated during passage through the digestive tract, preferably in accordance to the teaching of US 2004/0102377.
  • the composition may comprise, for example, any whey protein or a mixture of different whey proteins.
  • the composition may comprise proteinogenic matter derived, for example, from sweet whey obtained as a by-product in cheese manufacture, acid whey obtained as a by-product in acid casein manufacture, native whey obtained by milk micro filtration or rennet whey obtained as a byproduct in rennet casein manufacture may be used as the whey protein.
  • the composition comprises any one or more of proteinogenic matter based on ⁇ -lactoglobulin, a-lactalbumin, serum albumin, each independently in intact or hydrolyzed form, for example, and a combination of two or more of the aforementioned, besides possibly other proteinogenic matter.
  • the composition comprises whey protein micelles.
  • Whey protein micelles, their fabrication and beneficial properties, as well as numerous food products comprising whey protein micelles are disclosed in US 2009/0035437 Al, filed August 21, 2008, WO2007110421, filed March 27, 2007, and WO2007110411, filed March 26, 2007, which are entirely incorporated herein by reference. These references also disclose a process for obtaining whey protein micelles of advantageous properties, such as a particular size distribution. These whey protein micelles may be obtained from whey protein of the prior art and from whey protein fractions as disclosed elsewhere in this specification.
  • hydrophobic phase e.g., a fat droplet or air
  • hydrophilic phase e.g., a hydrophilic phase
  • Whey protein micelles preferably have a mean micelle diameter that is smaller than 1 micron, preferably being in the range of 100 nm and 900 nm, more preferably 100-770 nm, most preferably 200 and 400 nm.
  • the size distribution is such that more than 50%, preferably more than 80% of the micelles produced will have a size as indicated above.
  • the (mean) diameter of the micelles can be determined using transmission electron microscopy, for example as disclosed in the above-indicated references.
  • the whey protein does not undergo any hydrolysis step prior to micelle formation.
  • the whey protein is preferably not subjected to any enzymatic treatment prior to micellization.
  • the content of divalent cations in the whey protein for the preparation of the whey protein micelles concentrate may be less than 2.5%, more preferably less than 2%, even more preferably less than 0.2%.
  • the whey proteins are completely demineralized.
  • the whey protein aqueous solution comprising micelles is generally subjected to the heat treatment. It is preferred to have the temperature in the range of from about 70°C to below 95°C. Once the desired temperature has been reached, it is kept at this temperature for a minimum of 10 seconds and a maximum of 2 hours, preferably, 12 to 25 minutes.
  • the pH-adjusted and heat-treated aqueous solution comprising whey micelles is preferably concentrated, and may be used as such or may be dried, yielding a whey protein micelles powder. Before concentrating and/or before drying it is possible to conduct one or more purification steps, so as to increase the yield of micelles in the final preparation. Furthermore, whey protein micelles may be further treated and/or modified. For example, the whey protein micelles may be coated with an emulsifier, with peptides, proteins, gums, in order to modify the functionality and/or taste of the whey protein micelles.
  • the composition of the invention comprises antioxidants, vitamins and/or minerals.
  • the product may include a vitamin selected from the group consisting of vitamin A , vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12, vitamin C, vitamin D, in particular D3, vitamin E, vitamin K, folic acid, biotin, or combinations of two or more thereof.
  • a vitamin selected from the group consisting of vitamin A , vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12, vitamin C, vitamin D, in particular D3, vitamin E, vitamin K, folic acid, biotin, or combinations of two or more thereof.
  • the product may include a mineral selected from the group consisting of boron, calcium, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, nickel, phosphorus, potassium, selenium, silicon, tin, vanadium, zinc, or combinations of two or more thereof.
  • RDIs Dietary Reference Intakes
  • DRIs Dietary Reference Intakes
  • the dietary reference intakes are specified in accordance with the age of human subjects, in particular for the age classes 1-3, 4-8, 9-13, 14-18, 19-30, 31-50, 51-70 and subjects that are older than 70 years. As from the age class 9-13 years and upwards, RDIs are generally also gender specific.
  • vitamins and minerals may be present in dependence of the type of formula (supplemental and/or complete nutrition).
  • supplemental and/or complete nutrition may be present in dependence of the type of formula (supplemental and/or complete nutrition).
  • a specific formula may be suitable for complete nutrition, but may also be used in combination with normal or ordinary food and thereby be used as a supplementary nutrition.
  • some, several or all vitamins and/or minerals are present in amounts that correspond about to the RDI values, for example if it is assumed that the composition is used as complete nutrition. According to an embodiment, some, several or all vitamins and/or minerals are present in amounts that exceed the RDI values, Preferably, however, amounts are close to or below the tolerable upper intake level (UL), as established in the context of the RDIs (same reference as above). In certain cases, such as in case of a subject suffering from a specific disorder resulting in reduced absorption or uptake, the amount of one or several minerals and/or vitamins may be above the RDIs, for example about, at, slightly below or slightly above the ULs.
  • UL tolerable upper intake level
  • “Slightly”, in particular as used in the expressions “slightly above” and “slightly below” refer preferably to 20% or less, preferably 15% or less, more preferably 10%) or less of the respective amount.
  • the expression “about” refers to ⁇ 20%, preferably ⁇ 15%, more preferably ⁇ 10%, even more preferably ⁇ 5% and most preferably ⁇ 3% of the indicated value, in case a value is indicated.
  • the nutritional composition comprises macronutrients such as proteinogenic matter, carbohydrates, lipids, minerals and vitamins, wherein the amount of some, several or all vitamins and/or minerals exceeds or corresponds to the RDIs.
  • macronutrients such as proteinogenic matter, carbohydrates, lipids, minerals and vitamins
  • the amount of some, several or all vitamins and/or minerals exceeds or corresponds to the RDIs.
  • the amount of the vitamins some, several or all vitamins and/or minerals corresponds about to the UL value.
  • the composition of the invention comprises from about 800 to about 1200 kcal, preferably about 900 to about 1100 kcal, for example about lOOOkcal per daily administered dose to a child of 1 to 3 years.
  • the composition of the invention comprises from about 1250 to about 1750 kcal, preferably about 1350 to about 1650 kcal, for example about 1500kcal per daily administered dose to a child of 4 to 8 years.
  • the composition of the invention comprises from about 1550 to about 2250 kcal, preferably about 1650 to about 1950 kcal, for example about 1800kcal per daily administered dose to a child of 9 to 13 years.
  • the composition of the invention comprises from about 1850 to about 2150 kcal, preferably about 1900 to about 2100 kcal, for example about 2000 kcal per daily administered dose to a child of 9 to 13 years.
  • the composition has about 70-30 g dry matter, preferably 80 to 120 g, more preferably 90-110 g, 95-105 g, for example about 100 g dry matter per 500 kcal of the composition.
  • the composition is not nutritionally complete, but is a supplement or a pharmaceutical composition, for example in the form of a tablet, pill, and so forth.
  • the composition preferably has about 1 g to about 200 g per daily administered dose, about 1.5 g to about 100 g, preferably about 2-50 g, 3-40 g, 4-40 g, 5- 30 g, 6-20 g, 7-10 g per daily administered amount of the composition.
  • the weight-amounts of the specific components of the composition may be determined from indications elsewhere in this specification with respect to daily administered doses.
  • exogenous vitamin K 2 as part of the composition of the invention will improve osteocalcin carboxylation and improve indices of bone health during normal growth and development in children. Additionally, vitamin K 2 supplementation can also promote bone growth and bone quality in pediatric patients with underlying medical conditions in which bone growth and bone quality may be compromised. As a result, administration of exogenous vitamin K 2 is believed to increase bone density and improves bone tissue microarchitecture in pediatric patients, thereby reducing the incidence for fracture risk.
  • vitamin K 2 may be seen directly on bone quality such that this form of vitamin K modulates formation of proteins in the organic matrix of the bone involved in microarchitectural morphology, mineralization, density, elasticity and mechanical stiffness, as measured by peripheral quantitative computer tomography ("pQCT”) or Dual Energy X-ray absorptiometry (“DEXA”), for example.
  • pQCT peripheral quantitative computer tomography
  • DEXA Dual Energy X-ray absorptiometry
  • the composition comprises at least 25 ⁇ g vitamin K (any one or a combination of the aforementioned) or more per daily administered dose of the composition, in particular if administered to a 1 to 3 year old child.
  • the composition comprises at least or about 30 ⁇ g or more, at least or about 50 ⁇ g, at least or about 70 ⁇ g, at least or about 90 ⁇ g, at least or about 100 ⁇ g, at least or about 110 ⁇ g, at least or about 120 ⁇ g vitamin K or more per daily administered dose for a one to 3 year old child.
  • the composition comprises at least 45 ⁇ g vitamin K (any one or a combination of the aforementioned) or more per daily administered dose of the composition, in particular if administered to a 4 to 8 year old child.
  • the composition comprises at least or about 55 ⁇ g, at least or about 90 ⁇ g, at least or about 110 ⁇ g, at least or about 130 ⁇ g, at least or about 140 ⁇ g, at least or about 150 ⁇ g, at least or about 160 ⁇ g, at least or about 170 ⁇ g or more vitamin K per daily administered dose for a 4 to 8 year old child.
  • the composition comprises at least 50 ⁇ g vitamin K or more (any one or a combination of the aforementioned) per daily administered dose of the composition, in particular if administered to a 9 to 13 year old child.
  • the composition comprises at least or about 60 ⁇ g, at least or about 100 ⁇ g, at least or about 120 ⁇ g, at least or about 130 ⁇ g, at least or about 150 ⁇ g, at least or about 170 ⁇ g, at least or about 190 ⁇ g, at least or about 200 ⁇ g or more vitamin K per daily administered dose for a 9 to 13 year old child.
  • vitamins K per daily administered dose for a 9 to 13 year old child.
  • the composition preferably comprises not more than 500 mg, preferably not more than 400 mg, more preferably not more than 300 mg per daily administered dose. If the subject is a child that is 13 years old or younger the daily administered dose is preferably not more than 200 mg, preferably not more than 150 mg curcuminoid per daily administered dose.
  • a curcuminoid is a curcumin or a derivative of a curcumin with different chemical groups that have been formed to increase solubility of curcumins and make them suitable for drug formulation.
  • curcumimoids include curcumin itself IUPAC name (lE,6E)-l,7-bis (4-hydroxy-3-methoxyphenyl) -l,6-heptadiene-3,5-dione; also called diferuloylmethane), demethoxycurcumin, bisdemethoxy curcumin, keto and enol forms of the aforementioned and mixtures thereof.
  • the curcuminoid is curcumin, in particular natural curcumin or nature-identical, such as curcumin isolated from plants.
  • the composition comprises flavonoles, more preferably flavonoids, such as, for example, quercetin (also called xanthaurin or 3,3',4',5,7-pentahydroxyflavon, for example).
  • flavonoids such as, for example, quercetin (also called xanthaurin or 3,3',4',5,7-pentahydroxyflavon, for example).
  • the composition comprises >50 mg, >60 mg >70 mg, >80 mg >90 mg >100 mg >110 mg, >120 mg, >130 mg, >140 mg, >150 mg, >160 mg, >170 mg, >180 mg, >190 mg, >200 mg, >220 mg, >240 mg flavonoles, preferably flavonoids, in particular quercetin per daily administered dose.
  • the composition preferably comprises not more than 600 mg, preferably not more than 500 mg and most preferably not more than 400 mg of flavonoles per daily administered dose. If the composition is administered to a child that is 13 years or younger, the daily administered dose is preferably ⁇ 250 mg, more preferably ⁇ 200 mg and even more preferably ⁇ 175 mg flavonoles, preferably flavonoids, in particular quercetin per daily administered dose.
  • the composition of the invention comprises calcium (Ca 2+ ).
  • calcium salts such as calcium stearate, calcium lactate, calcium citrate, calcium phosphate and/or calcium gluconate, just to mention a few examples.
  • the composition comprises at least 450 mg calcium or more per daily administered dose of the composition, in particular if administered to a 1 to 3 year old child.
  • the composition comprises at least 500 mg, at least 800 mg, at least 900 mg, at least 1000 mg, at least 1100 mg, at least 1200 mg, at least 1800 mg or more calcium per daily administered dose for a one to 3 year old child.
  • the composition comprises at least 750 mg calcium per daily administered dose of the composition, in particular if administered to a 4 to 8 year old child.
  • the composition comprises at least or about 800 mg, at least or about 1500 mg, at least or about 1600 mg, at least or about 1700 mg, at least or about 1750 mg, at least or about 1800 mg, at least or about 2000 mg or more calcium per daily administered dose for a 4 to 8 year old child.
  • the composition comprises vitamin D (including vitamin D 2 and D 3 ).
  • the composition comprises at least 5 ⁇ g or more vitamin D per daily administered dose of the composition, in particular if administered to a 1 to 3 year old child.
  • the composition comprises at least or about 10 ⁇ g, at least or about 25 ⁇ g, at least or about 28 ⁇ g, at least or about 30 ⁇ g, at least or about 40 ⁇ g, at least or about 50 ⁇ g, at least or about 50 ⁇ or more vitamin D per daily administered dose for a one to 3 year old child.
  • the composition comprises at least 5 ⁇ g vitamin D or more per daily administered dose of the composition, in particular if administered to a 9 to 13 year old child.
  • the composition comprises at least or about 10 ⁇ g, at least or about 30 ⁇ g, at least or about 33 ⁇ g, at least or about 35 ⁇ g, at least or about 38 ⁇ g, at least or about 40 ⁇ g, at least or about 45 ⁇ g, at least or about 55 ⁇ g or more vitamin D per daily administered dose for a 9 to 13 year old child.
  • These or higher amounts preferably in accordance with RDIs and ULs, preferably also apply if the subject is a human subject that is 14 years or older.
  • the composition of the invention comprises phosphorous.
  • the composition comprises at least 460 mg or more phosphorous per daily administered dose of the composition, in particular if administered to a 1 to 3 year old child.
  • the composition comprises at least or about 650 mg, at least or about 700 mg, at least or about 750 mg, at least or about 770 mg, at least or about 780 mg, at least or about 900 mg, at least or about 1000 mg or more phosphorous per daily administered dose for a one to 3 year old child.
  • the composition comprises at least 1250 mg phosphorous or more per daily administered dose of the composition, in particular if administered to a 9 to 13 year old child.
  • the composition comprises at least or about 950 mg, at least or about 100 mg, at least or about 1200 mg, at least or about 1300 mg, at least or about 1350 mg, at least or about 1400 mg, at least or about 1410 mg, at least or about 1500 mg or more phosphorous per daily administered dose for a 9 to 13 year old child.
  • These or higher amounts preferably in accordance with RDIs and ULs, preferably also apply if the subject is a human subject that is 14 years or older.
  • the composition comprises at least or about 12 mg, at least or about 13 mg, at least or about 14 mg, at least or about 15 mg, at least or about 15.5 mg, at least or about 16 m, at least or about 18 mg, at least or about 20 mg or more iron per daily administered dose for a 4 to 8 year old child.
  • the composition comprises at least 8 mg iron or more per daily administered dose of the composition, in particular if administered to a 9 to 13 year old child.
  • the composition comprises at least or about 13 mg, at least or about 14 mg, at least or about 16 mg, at least or about 17 mg, at least or about 18 mg, at least or about 19 mg, at least or about 20 mg, at least or about 25 mg or more iron per daily administered dose for a 9 to 13 year old child.
  • These or higher amounts preferably in accordance with RDIs and ULs, preferably also apply if the subject is a human subject that is 14 years or older.
  • the composition comprises zinc.
  • the composition comprises at least 5 mg zinc or more per daily administered dose of the composition, in particular if administered to a 4 to 8 year old child.
  • the composition comprises at least or about 6 mg, at least or about 7 mg, at least or about 8 mg, at least or about 9 mg, at least or about 10 mg, at least or about 11 m, at least or about 12 mg, at least or about 14 mg or more zinc per daily administered dose for a 4 to 8 year old child.
  • the composition comprises at least 8 mg zinc or more per daily administered dose of the composition, in particular if administered to a 9 to 13 year old child.
  • the composition comprises at least or about 10 mg, at least or about 13 mg, at least or about 14 mg, at least or about 15 mg, at least or about 16 mg, at least or about 17 mg, at least or about 20 mg, at least or about 22 mg or more zinc per daily administered dose for a 9 to 13 year old child.
  • These or higher amounts preferably in accordance with RDIs and ULs, preferably also apply if the subject is a human subject that is 14 years or older.
  • the composition comprises at least 440 ⁇ g copper or more per daily administered dose of the composition, in particular if administered to a 4 to 8 year old child.
  • the composition comprises at least or about 1000 ⁇ g, at least or about 1200 ⁇ g, at least or about 1300 ⁇ g, at least or about 1350 ⁇ g, at least or about 1400 ⁇ g, at least or about 1450 ⁇ g, at least or about 1475 ⁇ g, at least or about 1500 ⁇ g, at least or about 2000 ⁇ g or more copper per daily administered dose for a 4 to 8 year old child.
  • the composition comprises at least 700 ⁇ g or more copper per daily administered dose of the composition, in particular if administered to a 9 to 13 year old child.
  • the composition comprises at least or about 1300 ⁇ g, at least or about 1400 ⁇ g, at least or about 1500 ⁇ g, at least or about 1600 ⁇ g, at least or about 1700 ⁇ g, at least or about 1750 ⁇ g, at least or about 4000 ⁇ g, at least or about 5000 ⁇ g or more copper per daily administered dose for a 9 to 13 year old child.
  • These or higher amounts preferably in accordance with RDIs and ULs, preferably also apply if the subject is a human subject that is 14 years or older.
  • the composition comprises magnesium.
  • the composition comprises at least 80 mg or more magnesium per daily administered dose of the composition, in particular if administered to a 1 to 3 year old child.
  • the composition comprises at least or about 100 mg, at least or about 140 mg, at least or about 160 mg, at least or about 170 mg, at least or about 180 mg, at least or about 200 mg, at least or about 230 mg or more magnesium per daily administered dose for a one to 3 year old child.
  • the composition comprises at least 240 mg or more magnesium per daily administered dose of the composition, in particular if administered to a 9 to 13 year old child.
  • the composition comprises at least or about 280 mg, at least or about 300 mg, at least or about 320 mg, at least or about 330 mg, at least or about 340 mg, at least or about 350 mg, at least or about 360 mg, at least or about 370 mg or more magnesium per daily administered dose for a 9 to 13 year old child.
  • These or higher amounts preferably in accordance with PvDIs and ULs, preferably also apply if the subject is a human subject that is 14 years or older.
  • the composition comprises at least 1.5 mg or more manganese per daily administered dose of the composition, in particular if administered to a 4 to 8 year old child.
  • the composition comprises at least or about 2 mg, at least or about 2.3 mg, at least or about 2.5 mg, at least or about 2.6 mg, at least or about 2.7 mg, at least or about 2.8 m, at least or about 2.9 mg, at least or about 3 mg or more manganese per daily administered dose for a 4 to 8 year old child.
  • the composition of the invention comprises further nutrients.
  • the composition comprises further macronutrients, besides proteinogenic matter, so as to provide a nutritionally balanced blend of nutrients, or a blend of nutrients that is possibly adapted to the need of the subject.
  • Cereals are a preferred source of carbohydrates.
  • the composition of the invention may contain lactose.
  • the composition of the invention is low in lactose or substantially lactose free. "Low in lactose” preferably means that less than 40%, preferably less than 30%), less than 20%>, less than 10%>, preferably less than 5%, most preferably less than 3% by weight of available carbohydrates being provided by lactose.
  • low in lactose means that less that 10% by weight of the composition, preferably less than 5%, more preferably less than 3% and most preferably less than 2% by weight of the composition is lactose.”
  • substantially lactose free means that lactose preferably provides less than 2%, preferably less than 1% and most preferably less than 0.5% of the weight of available carbohydrates of the composition.
  • substantially lactose free means that less than 1%, preferably less than 0.5% most preferably less than 0.3% by weight of the composition are provided by lactose. Percent by weight are percent by weight of dry matter for the purpose of this specification, unless otherwise indicated.
  • available carbohydrates provide about 30-75%), preferably 35-70%), more preferably 40-65%), most preferably 45-60%), for example 45-55% of the total caloric energy of the composition. These amounts may apply in particular if the composition is nutritionally complete.
  • the composition of the invention preferably comprises lipids.
  • Suitable sources of lipids include those that are useful for human nutrition and may be of any suitable origin, such as vegetal and animal oils or fat, for example.
  • Animal oils include milk fat and fish oil, for example.
  • Lipid sources include lipids obtained from milk, fish, eggs, seeds, nuts, fungi, microorganisms such as yeast and bacteria, for example.
  • Lipid sources include sources containing phospholipids, mono- di-, triglycerides, fatty acids, sterol-related compounds such as cholesterol, sphingosines, ceramides, glycosphingo lipids, gangluiosides and the like.
  • Preferred sources of lipids are milk, vegetal oils and fish oil.
  • the composition of the invention comprises polyunsaturated fatty acids (PUFAs), which may be selected, independently, for example, from omega-3 and from omega-6 fatty acids. According to an embodiment, the composition of the invention comprises omega-3 fatty acids.
  • PUFAs polyunsaturated fatty acids
  • the composition of the invention comprises one selected from eicosapentaenoic acid (EPA, 20:5, ⁇ -3), docosahexaenoic acid (DHA, 22:6, ⁇ -3), ⁇ -linolenic acid (ALA: 18:3 co-3), docosapentaenoic acid (DP A, 22:5, co-3), arachidonic acid (ARA, 20:4, ⁇ -6), and linoleic acid (LA: 18:2, co-6), and combinations thereof.
  • EPA eicosapentaenoic acid
  • DHA docosahexaenoic acid
  • ALA ⁇ -linolenic acid
  • DP A docosapentaenoic acid
  • ARA arachidonic acid
  • LA linoleic acid
  • the composition comprises at least 0.7 g of omega-3 fatty acids per daily administered dose, in particular if the subject is a 1-3 year old child.
  • the composition comprises at least 0.9 g of omega-3 fatty acids per daily administered dose, in particular if the subject is a 4-8 year old child.
  • the composition comprises at least 1.3 g of omega-3 fatty acids per daily administered dose, in particular if the subject is a 9-13 year old child.
  • the composition comprises at least 70 mg of EPA per daily administered dose, in particular if the subject is a 1-3 year old child.
  • the composition comprises at least 0.13 g of EPA per daily administered dose, in particular if the subject is a 9-13 year old child.
  • the composition of the invention comprises medium chain triglycerides (MTC).
  • MTC medium chain triglycerides
  • the lipids of the composition of the invention may comprise from 0 to 70%, preferably 1 to 60%, more preferably 2 to 50%, even more preferably, from 3 to 40% of MTC, in percent by weight of all lipids present in the composition.
  • lipids provide 15-55%), preferably 20-50%, more preferably 25-45%, most preferably 30-40% of the caloric energy of macronutrients of the composition. These mounts are particularly preferred if the subject is a 1-3 year old child. Furthermore, these amounts apply in particular if the composition is nutritionally complete.
  • lipids provide 10-50%), preferably 15-45%, more preferably 20-40%, most preferably 25-35% of the caloric energy of macronutrients of the composition, if the subject is a 4-9 year old child, or if the subject a human subject that is older than that. Furthermore, these amounts apply in particular if the composition is nutritionally complete.
  • the composition of the invention comprises nucleotides.
  • a "nucleotide” is understood to be a subunit of deoxyribonucleic acid (“DNA”) or ribonucleic acid (“RNA”). It is an organic compound made up of a nitrogenous base, a phosphate molecule, and a sugar molecule (deoxyribose in DNA and ribose in R A). Individual nucleotide monomers (single units) are linked together to form polymers, or long chains. Exogenous nucleotides are specifically provided by dietary supplementation.
  • the exogenous nucleotide can be in a monomeric form such as, for example, 5'-Adenosine Monophosphate ("5 - AMP”), 5'-Guanosine Monophosphate (“5'-GMP”), 5'-Cytosine Monophosphate (“5'-CMP”), 5'-Uracil Monophosphate (“5 -UMP”), 5'-Inosine Monophosphate (“5'-IMP”), 5'-Thymine Monophosphate (“5 -TMP”), or combinations thereof.
  • the exogenous nucleotide can also be in a polymeric form such as, for example, an intact RNA.
  • the composition comprises >5 mg, preferably >6 mg, >7 mg, >8 mg, >9 mg, and >10 mg of nucleotides per 100 g of dry matter of the composition.
  • the composition comprises >2.5 mg, preferably >3 mg, >3.5 mg, >4 mg, >4.5 mg, and >5 mg of nucleotides per daily administered dose of the composition.
  • the composition of the invention comprises one or more components selected from the macronutrients (proteinogenic matter, lipids, available carbohydrates), vitamins, minerals, nucleotides, phytonutrients and/or antioxidants selected from flavonoids, curcuminoids, limonins, carotenoids, lactowolfberry, wolfberry, polyphenols, lycopene, lutein, lignan, coenzyme Q10 ("CoQIO”), hesperidine and glutathione and combinations thereof and combinations thereof.
  • macronutrients proteinogenic matter, lipids, available carbohydrates
  • vitamins, minerals, nucleotides, phytonutrients and/or antioxidants selected from flavonoids, curcuminoids, limonins, carotenoids, lactowolfberry, wolfberry, polyphenols, lycopene, lutein, lignan, coenzyme Q10 ("CoQIO"), hesperidine and glutathione and combinations thereof and combinations thereof.
  • CoQIO coenzyme Q10
  • the composition of the invention comprises one or more selected from the macronutrients selected from proteinogenic matter, in particular whey protein, lipids, in particular lipids comprising omega-3 fatty acids, vitamins, minerals, nucleotides, phytonutrients and/or antioxidants (selected from flavonoids, curcuminoids, limonins, carotenoids, lactowolfberry, wolfberry, polyphenols, lycopene, lutein, lignan, coenzyme Q10 ("CoQIO”), hesperidine and glutathione and combinations thereof, for example) and combinations thereof.
  • the macronutrients selected from proteinogenic matter, in particular whey protein, lipids, in particular lipids comprising omega-3 fatty acids, vitamins, minerals, nucleotides, phytonutrients and/or antioxidants (selected from flavonoids, curcuminoids, limonins, carotenoids, lactowolfberry, wolfberry, polyphenols, lycopene, lutein, lig
  • the composition of the invention comprises one or more selected from the macronutrients selected from proteinogenic matter, in particular whey protein, lipids, in particular lipids comprising omega-3 fatty acids (in particular EPA), vitamins selected from vitamin K, vitamin D, calcium, phosphorous, iron, zinc, copper, magnesium, manganese, flavonoids, in particular quercetin, curcuminoids, in particular curcumin, and combinations thereof.
  • macronutrients selected from proteinogenic matter, in particular whey protein, lipids, in particular lipids comprising omega-3 fatty acids (in particular EPA), vitamins selected from vitamin K, vitamin D, calcium, phosphorous, iron, zinc, copper, magnesium, manganese, flavonoids, in particular quercetin, curcuminoids, in particular curcumin, and combinations thereof.
  • the composition of the invention comprises one or more selected from whey protein, lipids comprising omega-3 fatty acids (in particular EPA), vitamins selected from vitamin K, vitamin D, calcium, phosphorous, iron, zinc, copper, magnesium, manganese, flavonoids, in particular quercetin, curcuminoids, in particular curcumin and combinations thereof, for example at the amounts as specified elsewhere in this specification.
  • omega-3 fatty acids in particular EPA
  • the composition of the invention comprises one or more selected from whey protein, lipids comprising omega-3 fatty acids (in particular (EPA), vitamins selected from vitamin K, vitamin D, calcium, iron, zinc, magnesium, manganese, quercetin, curcumin and combinations thereof.
  • omega-3 fatty acids in particular (EPA)
  • the composition of the invention comprises one or more components and/or ingredients selected from whey protein, vitamin K, curcumin, quercetin, eicosapentaenoic acid (EPA), and nucleotides.
  • the subject consuming the composition of the invention, and/or the subject to whom the composition is administered conducts physical exercise.
  • the physical exercise refers to physical exercise that is part of a program.
  • the program is specifically adapted to the subject.
  • the program starts at a very low intensity level and exercise intensity or frequency is increased in accordance with the subject's capacities and evolution.
  • exercise or “physical exercise”, for the purpose of the present specification, refers to exercise that is part of an exercise program in accordance with the invention.
  • the exercise is described, prescribed or recommended to the subject.
  • the exercise program is preferably specifically defined.
  • the individual elements of the exercise are specifically described and/or defined and adapted to the subject.
  • evaluation may be performed by a health-care assistant or another trained person having experience in physical training and/or physical exercises, such as, for example, a physical therapist or a trainer.
  • the anaerobic threshold may be determined as described elsewhere in this specification for evaluating status of a subject.
  • an evaluation of the physical status of the subject is performed in any kind of automated way, for example by way of a questionnaire to be filled in, which may be on paper or computer assisted, for example on-line or via a computer program.
  • the physical exercises in accordance with the invention are defined or determined and distinguish in this way from other kind of activity, such as normal playing or sports taking place outside the frame of the present invention.
  • the physical exercise is defined in terms of one or more selected from actual, specific elements of physical exercise that are performed, quantity of exercises, frequency, regularity and period of treatment, during which the exercise program is conducted, and combinations thereof. It is possible and even preferred that some parameters of physical activity evolve in the course of the exercise program. In particular, it is expected that physical capacities (muscle strength, endurance, and so forth) develop in a positive way and that frequency and/or intensity of exercise can be increased, or that further, additional exercises can be added in the course of the program. Without wishing to be bound by theory, it is envisaged that motivation, health status, musculoskeletal status and so forth are increased.
  • the physical exercise program is preferably designed so as to avoid repetitions that could be experienced as boring.
  • the physical exercise program preferably avoids non-compliance by the subject, for example due to repetitions or because the program is not adapted to the subject.
  • the physical exercise may be of any form.
  • the exercise program comprises anaerobic exercise.
  • anaerobic exercise also referred to resistance exercise
  • resistance exercise is suitable to provide an effective osteogenic stimulus.
  • the overload stimulus of resistance exercise and contraction of skeletal muscle during exercise provides loading forces to the underlying bones.
  • the resistance exercise promotes anabolism, for example for lean mass accretion.
  • the physical exercise may also comprise aerobic exercise, and a combination of both anaerobic and aerobic exercise.
  • the increased physical activity may be used to help to minimize excessive adiposity and/or obesity in some subjects.
  • the optimization of body composition to increase lean body mass will have a positive impact on glucose control/insulin sensitivity.
  • the step of conducting physical exercise in the method and/or treatment of the invention comprises demonstrating a physical exercise to a child and/or preparing physical exercises with said child.
  • the physical exercise or exercise program may include the use of any device, tool and/or toy or may not make use of devices, tools and/or toys.
  • the exercise includes games.
  • the physical exercise involves the use of weight machines.
  • the physical exercise involves the use of free weights or weight units that can be attached to the body of the subject.
  • the physical exercise involves the use of any kind of resilient device, which can be actuated by a subject whit the aid of muscular strength and which, by way of its resilience, returns to an original state once muscular effort is reduced.
  • the physical exercise involves the use of elastic bands, for example therabands.
  • the physical exercise involves the use of a hand-grip.
  • the physical exercise involves the use of any kind of resilient device, which can be actuated by a subject whit the aid of muscular strength and which, by way of its resilience, returns to an original state once muscular effort is reduced.
  • the physical exercise involves the use of medicine balls.
  • the physical exercise comprises the use of a combination of one or more of the aforementioned.
  • the physical exercise involves the use of electronically-assisted and/or computer-assisted games.
  • the physical exercise preferably involves games that make use of motion sensors, such as sensors of acceleration, slowing down or change of direction and/or orientation, such as gyroscopes, for example.
  • a tactile carpet, panel, pad and/or covering For example, a carpet-like tactile device can sense where a subject touches the carpet, for example by his feet or hands, and process the data to yield a specific result, for example in a game.
  • Typical examples of electronically- and/or computer-assisted games and devices involving the physical exercise are Wii stations, for example using force plates and the like.
  • Other examples include PlayStationTM and X-BoxTM, which may be used and/or adapted for the purpose of conducting physical exercise in accordance with the present invention.
  • the physical exercise comprises free exercises, which do not require any further instrument or device, such as push-ups, squats, semi-squats, and so forth.
  • the physical exercises are home based, that is they can be performed at home by the subject.
  • the actually conducted exercises by the subject are recorded and/or tracked.
  • the method and/or treatment of the invention thus preferably comprises the step of tracking physical exercise performed by the subject.
  • any one selected from progress, compliance with the program and exercise progression is tracked and/or recorded.
  • Exercises performed by the subject can be noted on paper, but are preferably stored in a database.
  • the actual exercises and associated parameters such as time spent with an exercise, number of repetitions, intensity, and the like are registered by way of a computer-assisted device, in particular a computer.
  • the actually performed exercises may be entered into the database by the subject her-/himself or by another person, such as an assistant or by parents, for example.
  • exercises involving a computer are tracked automatically during exercising.
  • the exercise program involves an interactive, computer-based and/or computer-assisted device comprising input and output elements.
  • the exercise program involves visual out- and/or inputs.
  • the subject or another person may enter performed exercises via a input device, such as a joy-stick, a computer mouse, a keypad, but preferably via a visual input device, such as, for example, tactile screen.
  • the computer-assisted device recording and/or tracking the exercises of a subject comprises a computer pad or a so-called smart tablet with a tactile screen, of the iPad or Motorola Xoom-type, for example.
  • the subject can enter achievements in terms of the physical exercise program and preferably an output is generated.
  • the output preferably contains messages and/or images that are motivating, congratulating and/or encouraging the subject to continue exercises, and/or that show achievements, progress, and the like.
  • a exercise device for example for conducting resistance exercises, measures forces imparted on the body and a visual feedback corresponding to the force, for example on a monitor or screen, is created.
  • input signals can be determined using therabands and/or force plates, for example measuring force.
  • the computer-assisted or computer-based device involves an on-line system, where date and information with respect to physical exercises and progress can be introduced and possibly commented. Furthermore, there may be on-line feedback, for example mediated by the internet. Furthermore, there may be interactions between subjects in accordance with the invention over said computer-based device. There may also be group activities and games between subjects belonging, preferably, to the same age group.
  • the physical exercise is regular, or the exercise program involves regular exercise.
  • regular exercise does not imply that exactly the same exercise is conducted regularly, but also encompasses different exercises or a series of different exercises that is repeated.
  • exercises are conducted at regular intervals. For example, exercises are conducted one, two or three times a day, every day, every other day, every three days, every four days, and so forth.
  • exercises are conducted once a week, twice a week, three times a week, four times a week, five times a week, six times a week, seven times a week, eight times a week, nine times a week, or more often per week.
  • physical exercise or “exercise” is preferably different from physical activity in general, the latter term referring to physical activity of a subject taking place outside the context of the invention, and in particular activity that is not part of the exercise program of the invention, for example as specified herein.
  • Physical activity refers generally to aerobic activity.
  • the exercise are preferably conducted over a certain minimum period, the minimum period being, for example, a week, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks, one month, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months, a year or over a total period that is more than one year.
  • the individual elements of exercise for example a specifically developed game certain of a Wii station
  • Adaptation involves reduction and/or increase of the intensity or frequency of exercise, in dependency of progress being made or general health status of the subject.
  • the period of treatment is thus preferably the minimum period.
  • the physical exercise is conducted in the frame of an exercise program adapted to physical capacities of said child, wherein said exercise program comprises different exercise elements and wherein the same or different exercise elements are conducted after periods of time over a treatment period.
  • the beneficial effects reported in this specification are obtained in a subject that consumes the composition of the invention and that also undergoes exercise as disclosed elsewhere in this specification.
  • the composition is consumed repeatedly over a certain time, preferably regularly, and the exercise is also conducted repeatedly over the time span of the treatment, preferably regularly.
  • the composition is preferably administered several times a day, daily, every other day, every three days, at least 7 times or more per week, 6 times or more per week, 5, 4, 3, 2, or on 1 day or more per week, in particular during the treatment period.
  • the treatment thus preferably encompasses administration of the composition and physical exercise.
  • the composition is preferably administered in the same overall period as the exercises are conducted.
  • the duration of the treatment period corresponds in general to the period, for example the minimum period specified with respect to the exercise or exercise program.
  • the composition as defined elsewhere in this specification is administered for a longer or shorter overall period than the period for exercise.
  • the composition may be administered before the start of the physical exercise program, or vice versa.
  • the composition may be administered even beyond the period of physical exercise, or the exercise program may be continued while administration of the composition is stopped.
  • treatment for the purpose of the present specification, may have different meanings.
  • treatment and “treat” are used to refer to the obtainment of the beneficial effects of the invention.
  • treatment refers to improvement of life and/or health status in a subject, for example by stopping or improving a disease or an unhealthy condition, slowing down progress of a disease state or of an unhealthy condition.
  • treatment thus may refer to medical treatment, therapy and/or prophylactic treatment.
  • treatment is generally used in this specification to refer to the nutrition and/or exercise program of the present invention.
  • the treatment in this regard, thus refers to the administration of the composition of the invention in combination with conducting the physical exercise, in particular a physical exercise program, for example as exemplified in this specification.
  • the term “treatment” could possibly be replaced or defined by the terms “program”, “process”, “procedure”, “accomplishment”, “execution” and the like.
  • composition of the invention preferably in combination with physical exercise, provides several important health benefits
  • teaching of the present invention is suitable to improve life quality, to improve well-being, to support growth, to ensure healthy growth, improves and/or supports musculoskeletal state and/or health, to increase muscle and/or bone mass, density, formation and/or mineral content, and further benefits as reported elsewhere in this specification.
  • the invention comprises monitoring and/or assessment of the effects of the invention, progress of the subject in terms of the effects of the invention.
  • the musculoskeletal state, muscle strength, bone density, bone mineral content, and the like are assessed, preferably several times during the exercise or treatment period, for example at the beginning, in the curse of, and at the end of the treatment period.
  • the effect of the treatment in accordance with the invention is assessed and/or monitored.
  • the quality of life may be assessed employing the validated Medical Outcomes Study 36-item Short-Form General Health Survey.
  • the questionnaire consists of 36 questions, is self administered and assesses quality of life and wellbeing in 8 multi item scales regarding physical functioning and perception of physical role, vitality, general and mental health, perception of emotional role, social functioning and bodily pain.
  • the quality of life may also and/or alternatively be assessed using measures of self-confidence.
  • the effects of the present invention may, generally, be assessed by measures of physical performance (muscle strength, power and/or balance), by biomarkers of bone turnover (e.g. NTx, osteocalcin) and inflammation (e.g. TNFa, CRP, IL-6), quantification of lean body mass (Bod Pod, BIA, MRI), bone growth (Micro Computed Tomography, Magnetic Resonance Imaging-MRI), analyses of whole blood cells (gene microarray for network genes with respect to musculoskeletal areas.
  • biomarkers of bone turnover e.g. NTx, osteocalcin
  • inflammation e.g. TNFa, CRP, IL-6
  • Increased muscle strength and other effects of the invention may be obtained using the following exercises and/or protocols, which are in particular also used for assessing the presence of the effects of the invention, that is, the progress of the subject in accordance with the effects of the invention.
  • hand grip strength is improved, assessed and/or monitored.
  • Hand grip strength may, for example, be measured in the non-dominant hand with a Digimax electronic dynamometer (Mechatronic Hamm GmbH, Germany). The subject performs the test while sitting comfortably with shoulder adducted and neutrally rotated, the elbow supported on a table and flexed to 90 degrees, forearm and wrist in neutral position. The subject will be instructed to perform a maximal isometric contraction. The test will be repeated within 30 seconds and the highest value was recorded.
  • isokinetic peak torque and isometric strength of muscles is improved, assessed and/or monitored. This may be made using an isokinetic dynamometer.
  • Such devices may be used for a variety of muscles, such as for example, flexors and extensors of limps and/or articulations.
  • an isokinetic dynamometer may be used to assess isokinetic peak torque and isometric strength of knee or elbow flexors and extensors.
  • the physical activity in particular during the exercises of the program in accordance with the invention, is monitored.
  • Physical activity is, for example, monitored in order to assess and/or compare the combined effects of the administration of the composition and the physical exercise in accordance with the invention.
  • the effects may be compared to effects obtained in subjects that do not consume the composition of the invention.
  • activity levels in general may be compared of subjects that undergo the combined treatment of specific nutrition and physical exercise in accordance with the invention with subjects that do not undergo the treatment of the invention.
  • physical activity may objectively measured, assessed and/or evaluated by way of accelerometry.
  • Accelerometry may be performed, for example, using the Actigraph Model GT3X (Manufacturing Technology Inc., FL, USA).
  • the actigraph is generally worn superior to the iliac crest in a custom pouch, secured to the subject's belt by a plastic fastening. Assessments can be made at baseline and 6 months.
  • These accelerometers are small enough to be unobtrusive and produce little interference with normal physical activity. Subjects will be instructed to wear the actigraph for a 7-day period during waking hours and remove it for sleep and bathing only. Activity is preferably recorded using 1 -second epochs.
  • accelerometry allows objective measurement of physical activity by the use of a motion sensor which records both the number and magnitude of vertical accelerations generated by a subject's movement. Both the volume and intensity of physical activity can be quantified.
  • the "Short Physical Performane Battery (SPPB) is a test and/or physical exercise for training and/or assessing force, strength, endurance, balance and speed in particular of the muscles and/or musculoskeletal system of the lower limps.
  • the test comprises the subtests of 1.) 4 meter walk 2) five timed chair rises. 3) one or more simple balance tests. Results from each subtest are ranked using a 0-4 scale and the composite score is summed.
  • Guralnik, et al. A short physical performance battery assessing lower extremity function: Association with self-reported disability and prediction of mortality and nursing home admission. In: J Gerontol. 49. 1994, 2, M85-M94.
  • the anaerobic power of the muscles and/or musculoskeletal system of the lower body may be increased, measured, assessed and/or monitored using, for example, the Wingate anaerobic cycling test (WANT).
  • WANT Wingate anaerobic cycling test
  • An arm ergometer can be used for improving and/or assessing upper body anaerobic power. Eur J Appl Physiol (1983) 51 : 409-417.
  • the aerobic power of muscle and/or of the musculoskeletal system may be increased, measured, evaluated, assessed and/or monitored using, for example, one or more grade exercise tests (GXT) to assess peak oxygen uptake, for example.
  • GXT grade exercise tests
  • Such a test may be used to evaluate an subject's physiological response (e.g. heart rate, blood pressure, and oxygen consumption) to exercise, the intensity of which is increased in stages.
  • These tests can be performed using a bench (for step-ups), a cycle ergometer, or a treadmill.
  • a typical test on a treadmill starts with a subject walking gently on a revolving belt, which is accelerated at three minute intervals until the subject is running at maximum pace or until the subject experiences any discomfort or irregularities (e.g. of heartbeat).
  • Heart rate and oxygen consumption are monitored continuously. Blood pressure is measured at rest, during exercise, and after exercise. GXTs provide estimates of the ability of the lungs, heart, and blood vessels to deliver oxygen to respiring tissue; therefore they are measurements of aerobic fitness or power or cardiorespiratory fitness. This test may be used, for example, for assessing the anaerobic threshold in a subject.
  • the invention is suitable to increase bone health in an individual. More specifically, the invention is suitable to improve bone microarchitectural morphology, bone mineralization, bone density, bone elasticity and mechanical stiffness of bones. These parameters may be assessed, for example, by peripheral quantitative computer tomography ("pQCT") or Dual Energy X-ray absorptiometry ("DEXA").
  • pQCT peripheral quantitative computer tomography
  • DEXA Dual Energy X-ray absorptiometry
  • bone density is expressed as the relationship between bone mass (expressed as the degree of photon attenuation through the bone, or bone mineral content (BMC)) and the image of the bone on a film (i.e., the area) (expressed as BMC/cm 2 ).
  • pQCT is a procedure that evaluates peripheral bone in 3 dimensions (volumetric) and is commonly applied to the forearm or tibia.
  • a radiation source typically x-rays
  • a sensor revolve around the bone under examination, which is them reconstructed on the computer screen in a three-dimensional (3-D) image.
  • pQCT is an optimal technique for evaluating bone geometry even though sensitivity varies with the site under evaluation.
  • pQCT measures true bone density (volumetric mineral bone density) because it normalizes the bone mineral content derived not from the projected area but rather from the volume of the examined bone.
  • pQCT can also be used to calculate the SSI, an index of bone resistance to torsion.
  • the index takes into account bone geometry and the bone's mineral characteristics. See, Geometry and bone density, Radetti, G., et al., Panminerva Med 2006; 48: 181-6.
  • DEXA is based on x-ray spectrometry and its fundamental principle is based on the degree of attenuation of x-rays emitted from 2 different sources of energy.
  • DEXA is normally used to evaluate lumbar or proximal femoral bone mineralization.
  • DEXA has an accuracy of 4-10% and a coefficient of variation of 1-1.5%.
  • a powdered nutritional composition is prepared in a conventional manner using powdered whey protein micelles as disclosed in US 2009/0035437, Example 13, as only protein source, glucose syrup, sucrose, milk fat, medium chain triglycerides (MCT oil), corn oil, soy lecithin as emulsifier, potassium citrate, calcium phosphate, sodium citrate, calcium carbonate, magnesium chloride, acidity regulator: potassium hydroxide, potassium chloride, vitamins: C, E, niacin, panthothenic acid, B6, thiamin (Bl), A, riboflavin (B2), D, folic acid, K, biotin, B12,; choline bitatrtrate, ferrous sulphate, zinc sulphate, magnesium oxide, manganese sulphate, copper sulphate, sodium molybdate, potassium iodide, chromium chloride, sodium selenate.
  • Table 1 The detailed nutritional composition is given in Table 1 below:
  • a serving size of the composition is prepared by mixing 50 g of the powder with about 210 ml with clean water (e.g. non-carbonated mineral water), so as to yield about 250 ml.
  • clean water e.g. non-carbonated mineral water
  • the defined exercises are conducted in accordance with the program and accomplishment will subsequently entered by the boy himself in a user-friendly database using a computer with a tactile screen and graphic interface (an iBook), where the boy will immediately indicate the exercise conducted by touching the corresponding symbol on the screen and indicating the number of repetitions and/or exercises conducted.
  • the computer will generate an output in dependence of the input in order to motivate and encourage the boy to increase exercise intensity and/or frequency or to simply reward the boy for the exercises that were achieved. The boy will be free to continue exercises beyond the program schedule if he feels like.

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Polymers & Plastics (AREA)
  • Food Science & Technology (AREA)
  • Nutrition Science (AREA)
  • Mycology (AREA)
  • Medicinal Chemistry (AREA)
  • Pediatric Medicine (AREA)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Botany (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne un traitement ou programme comprenant l'administration d'une composition nutritionnelle et des exercices physiques, en particulier dans le cadre d'un programme d'exercices réguliers, pour assurer la croissance saine et améliorer la qualité de vie des enfants, par exemple. L'invention vise en particulier des enfants à la santé compromise et des enfants ayant une nutrition sous-optimale. Le traitement de l'invention est approprié pour améliorer la santé musculosquelettique chez un sujet. En particulier, le traitement de l'invention est approprié pour augmenter la résistance musculaire, la puissance musculaire, l'endurance musculaire, la santé des os, la résistance des os, et la densité des os.
PCT/EP2013/056645 2012-03-29 2013-03-28 Amélioration de la santé musculosquelettique par nutrition et exercice WO2013144267A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261617334P 2012-03-29 2012-03-29
US61/617,334 2012-03-29

Publications (2)

Publication Number Publication Date
WO2013144267A2 true WO2013144267A2 (fr) 2013-10-03
WO2013144267A3 WO2013144267A3 (fr) 2013-12-05

Family

ID=48190469

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2013/056645 WO2013144267A2 (fr) 2012-03-29 2013-03-28 Amélioration de la santé musculosquelettique par nutrition et exercice

Country Status (1)

Country Link
WO (1) WO2013144267A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016128503A1 (fr) * 2015-02-11 2016-08-18 Bioactor Bv Composés et compositions destinées à l'amélioration de la puissance développée et du rendement de la consommation d'oxygène
US20200368266A1 (en) * 2015-11-17 2020-11-26 Société des Produits Nestlé S.A. Compositions and methods using a polyphenol for musculoskeletal health

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040102377A1 (en) 2001-04-10 2004-05-27 Irene Perrin Method and composition for prophylaxis of diabetes
WO2007110411A2 (fr) 2006-03-27 2007-10-04 Nestec S.A. Micelles de proteines de lactoserum

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040180708A1 (en) * 2003-03-14 2004-09-16 Southard Barbara Helen Health based internet game for children
NL1034964C2 (nl) * 2008-01-28 2009-07-30 Friesland Brands Bv Werkwijze en composities voor de behandeling van botaandoeningen.
CN102596190A (zh) * 2009-09-14 2012-07-18 雀巢产品技术援助有限公司 包含外源性维生素k2的营养组合物

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040102377A1 (en) 2001-04-10 2004-05-27 Irene Perrin Method and composition for prophylaxis of diabetes
WO2007110411A2 (fr) 2006-03-27 2007-10-04 Nestec S.A. Micelles de proteines de lactoserum
WO2007110421A2 (fr) 2006-03-27 2007-10-04 Nestec S.A. Micelles de protéines de lactosérum
US20090035437A1 (en) 2006-03-27 2009-02-05 Nestec S.A. Whey protein micelles

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
"Food and Nutrition Board", 2004, NATIONAL ACADEMIES, article "Dietary Reference Intakes (DRIs): Recommended Intakes for Individuals"
EUR J APPL PHYSIOL, vol. 51, 1983, pages 409 - 417
RADETTI, G. ET AL., PANMINERVA MED, vol. 48, 2006, pages 181 - 6

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016128503A1 (fr) * 2015-02-11 2016-08-18 Bioactor Bv Composés et compositions destinées à l'amélioration de la puissance développée et du rendement de la consommation d'oxygène
US11304967B2 (en) 2015-02-11 2022-04-19 Bioactor Bv Compounds and compositions for improving power output and oxygen efficiency
EP4257204A3 (fr) * 2015-02-11 2023-11-29 BioActor B.V. Composés et compositions destinés à l'amélioration de la puissance développée et du rendement de la consommation d'oxygène
US20200368266A1 (en) * 2015-11-17 2020-11-26 Société des Produits Nestlé S.A. Compositions and methods using a polyphenol for musculoskeletal health
US11813273B2 (en) * 2015-11-17 2023-11-14 Societe Des Produits Nestle S.A. Compositions and methods using a polyphenol for musculoskeletal health

Also Published As

Publication number Publication date
WO2013144267A3 (fr) 2013-12-05

Similar Documents

Publication Publication Date Title
Jeukendrup et al. Sport nutrition
US20190209501A1 (en) Compositions and methods of use of beta-hydroxy-beta-methylbutyrate (hmb) assosiated with intermittent fasting
WO2013144267A2 (fr) Amélioration de la santé musculosquelettique par nutrition et exercice
WO2013144268A1 (fr) Nutrition et exercice physique contre la malnutrition associée à la prise de médicaments chez les enfants
Hannon et al. Nutritional strategies to support young athletes
American Medical Association American Medical Association Complete Guide to Prevention and Wellness: What You Need to Know about Preventing Illness, Staying Healthy, and Living Longer
Rani Physical fitness and wellness
Applegate Encyclopedia of sports & fitness nutrition
Susan Kazen Nutrition and Fitness
Shepherd et al. Food and Nutrition Throughout Life: A comprehensive overview of food and nutrition in all stages of life
Nichole Dandrea-Russert The Vegan Athlete's Nutrition Handbook: The Essential Guide for Plant-Based Performance
Nickless Sports Nutrition for Masters Athletes
Gupta Uttar Pradesh Rajarshi Tandon Open University
Efferding et al. The Vertical Diet: A Simple, Sensible, and Sustainable Lifestyle Plan to Improve Body Composition F Or Optimal Health and Performance
Baxter Nutrition for Healthy Children and Adolescents Aged 2 to 18 Years
Palacio Nutrition for the Female Athlete
LOSS Dr. JB Winters
Barata Efects of Acute Sodium Bicarbonate Supplementation on Repeate Sprint Ability in Female Football Players
Boutcher Belly Fat Breakthrough
AYÇA et al. The habits of wrestlers to use nutrition, nutritional supplements, beverages, medicine and vitamins
Bachl et al. Sport nutrition
Reiber Effect of Carbohydrate Loading vs. Fasting on Blood Glucose Levels in a 400 Meter Sprint Performance
Fukuda et al. Nutritional strategies to optimize youth development
Lam Acute Effects of Low-Fat Chocolate Milk Intake on Muscle Recovery following Lower Extremity Exhausting Exercise
Burgoon Practical Nutrition for Sports Medicine and Fitness Professionals

Legal Events

Date Code Title Description
122 Ep: pct application non-entry in european phase

Ref document number: 13718797

Country of ref document: EP

Kind code of ref document: A2