WO2005123108A2 - Composition a base de vitamine c elaboree presentant une biotransformation amelioree et utilisation de proteines et de l-carnitine pour complementation nutritionnelle ou analogue - Google Patents

Composition a base de vitamine c elaboree presentant une biotransformation amelioree et utilisation de proteines et de l-carnitine pour complementation nutritionnelle ou analogue Download PDF

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Publication number
WO2005123108A2
WO2005123108A2 PCT/US2005/020421 US2005020421W WO2005123108A2 WO 2005123108 A2 WO2005123108 A2 WO 2005123108A2 US 2005020421 W US2005020421 W US 2005020421W WO 2005123108 A2 WO2005123108 A2 WO 2005123108A2
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Prior art keywords
carnitine
milligrams
vitamin
mixture
set forth
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PCT/US2005/020421
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English (en)
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WO2005123108A3 (fr
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William Feinstein
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William Feinstein
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Priority to CA002514687A priority Critical patent/CA2514687A1/fr
Publication of WO2005123108A2 publication Critical patent/WO2005123108A2/fr
Publication of WO2005123108A3 publication Critical patent/WO2005123108A3/fr

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    • 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
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • 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
    • A23L33/18—Peptides; Protein hydrolysates
    • 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
    • A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
    • A23L33/28—Substances of animal origin, e.g. gelatin or collagen
    • 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
    • A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/01—Hydrolysed proteins; Derivatives thereof
    • A61K38/012—Hydrolysed proteins; Derivatives thereof from animals
    • A61K38/014—Hydrolysed proteins; Derivatives thereof from animals from connective tissue peptides, e.g. gelatin, collagen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • 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 generally to healthcare products and, more particularly, to an improved nutritional supplement and method of using the same.
  • nutritional supplements usually comprise a mixture of vitamins and minerals in dosages set according to USDA minimum daily nutritional requirements. While these supplements may be suitable for some, what is often necessary for providing adequate nutrition and concomitant energy boost typically varies from one person to the next, and depends on their body mass, age, biochemical makeup and other considerations. These considerations have, in turn, prompted the development of a plethora of vitamin and nutritional concoctions that not only provide much needed vitamins and minerals, but also Proteins and other constituents intended to enhance health and generally make the user feel "good".
  • a nutritional supplement having key ingredients that are not only readily available, affordable, and manufacturable, but are also provided in concentrations that are highly effective for improving the overall health, comfort, vitality, well being, strength and stamina of individuals in need of key nutritional supplements.
  • Such supplement would be particularly desirable for administration to persons including, but not limited to: (i) older individuals; (ii) individuals having no or relatively low levels of activity, such as patients under treatment in hospitals and/or other healthcare institutions, or under medical supervision and/or outpatient care; (iii) individuals in need of nutritional supplementation, such as athletes and pregnant women; and (iv) patients suffering from wounds and/or diseases, including kidney failure.
  • a nutritional supplement which comprises a selected source of Vitamin C, in mixture, with (i) a selected Protein source comprising essential amino acids, or (ii) a selected source of L-Carnitine, or (iii) a mixture of (i) and (ii).
  • a nutritional supplement which comprises at least a selected source of Vitamin C in mixture with a selected source of Protein.
  • a nutritional supplement which comprises at least a selected source of Vitamin C in mixture with a selected source of L-Carnitine.
  • a nutritional supplement which comprises Vitamin C, in mixture, with (i) Hydrolyzed Collagen Protein, or (ii) L-Carnitine, or (iii) a mixture of (i) and (ii).
  • a nutritional supplement is provided which comprises at least Vitamin C in mixture with Hydrolyzed Collagen Protein.
  • a nutritional supplement is provided which comprises at least Vitamin C in mixture with L- Carnitine.
  • a nutritional supplement which comprises Vitamin C generally within a range of 100 milligrams and 5000 milligrams, in mixture, with: (i) a selected Protein source having essential amino acids generally within a range of 1 gram and 150 grams; or (ii) L-Carnitine generally within a range of 100 milligrams and 5000 milligrams; or (iii) a mixture of (i) and (ii).
  • Another aspect of the present invention relates to a nutritional supplement which comprises Vitamin C, or a source thereof, generally within a range of 250 milligrams and 5000 milligrams, in mixture, with: (i) a selected Protein source having essential amino acids generally within a range of 1 gram and 150 grams; or (ii) L-Carnitine, or a source thereof, generally within a range of 100 milligrams and 5000 milligrams; or (iii) a mixture of (i) and (ii).
  • a nutritional supplement which comprises Vitamin C generally within a range of 250 milligrams and 1500 milligrams, in mixture, with: (i) Hydrolyzed Collagen Protein generally within a range of 7.5 grams and 45 grams; or (ii) L-Carnitine generally within a range of 500 milligrams and 3000 milligrams; or (iii) a mixture of (i) and (ii).
  • a nutritional supplement which comprises, in an aqueous-based mixture, a selected source of Vitamin C with (i) one or more selected Protein sources having essential amino acids, or (ii) a selected source of L-Carnitine, or (iii) a mixture of (i) and (ii).
  • a nutritional supplement which comprises, in a non-aqueous-based mixture, a selected source of Vitamin C with (i) one or more selected Protein sources having essential amino acids, or (ii) a selected source of L-Carnitine, or (iii) a mixture of (i) and (ii).
  • a nutritional supplement in tablet form, which comprises a selected source of Vitamin C and (i) a selected source of L-Carnitine, and/or (ii) one or more selected Protein sources having essential amino acids.
  • a nutritional supplement, in gel capsule form which comprises a selected source of Vitamin C and (i) a selected source of L-Carnitine, and/or (ii) one or more selected Protein sources having essential amino acids.
  • a nutritional supplement which comprises, in a skin patch, a selected source of Vitamin C and (i) a selected source of L-Carnitine, and/or (ii) one or more selected Protein sources having essential amino acids.
  • a nutritional supplement which comprises, in a powder for reconstitution, a selected source of Vitamin C and (i) a selected source of L-Carnitine, and/or (ii) one or more selected Protein sources having essential amino acids.
  • a nutritional supplement which comprises, in a nutritional bar or other food, a selected source of Vitamin C and (i) a selected source of L-Carnitine, and/or (ii) one or more selected Protein sources having essential amino acids.
  • a nutritional supplement is provided which comprises, in mixture, Vitamin C and soy protein and or L-Carnitine.
  • a nutritional supplement is provided which comprises, in mixture, Vitamin C and L-Carnitine and/or a selected Protein source having essential amino acids.
  • a nutritional supplement which comprises at least about 250 milligrams of Vitamin C, in mixture, with (i) a selected source of L-Carnitine, and/or (ii) a selected Protein source comprising essential amino acids.
  • the method comprises the steps of dispensing to a patient a does, e.g., daily, of between about 15 and about 60 milliliters of an aqueous-based liquid containing dissolved concentrations of between about 250 milligrams and about 5000 milligrams of Vitamin C and (i) between about 100 and about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram and about 150 grams of a Hydrolyzed Collagen Protein.
  • a method of treatment using a nutritional supplement is e.g., daily, of between about 15 and about 60 milliliters of an aqueous-based liquid containing dissolved concentrations of between about 250 milligrams and about 5000 milligrams of Vitamin C and (i) between about 100 and about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram and about 150 grams of a Hydrolyzed Collagen Protein.
  • a nutritional supplement e.g., daily
  • the method comprises the steps of dispensing to a patient a dose, e.g., daily, of between about 15 and about 90 milliliters of an aqueous-based liquid containing dissolved concentrations of between about 250 milligrams and about 5000 milligrams of Vitamin C and (i) between about 100 and about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram and about 150 grams of a Hydrolyzed Collagen Protein.
  • a dose e.g., daily
  • an aqueous-based liquid containing dissolved concentrations of between about 250 milligrams and about 5000 milligrams of Vitamin C and (i) between about 100 and about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram and about 150 grams of a Hydrolyzed Collagen Protein.
  • Yet another aspect of the present invention is a method of treatment using a nutritional supplement, the method comprising the step of dispensing to a patient a dose, e.g., daily, of between about 15 and about 60 milliliters of a non-aqueous-based liquid containing dissolved concentrations of between about 250 milligrams and about 5000 milligrams of Vitamin C and (i) between about 100 and about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram and about 150 grams of a Hydrolyzed Collagen Protein.
  • a dose e.g., daily
  • a dose e.g., daily
  • Still another aspect of the present invention is a method of treatment using a nutritional supplement, the method comprising the step of dispensing to a patient a dose, e.g., daily, of between about 15 and about 90 milliliters of a non-aqueous-based liquid containing dissolved concentrations of between about 250 milligrams and about 5000 milligrams of Vitamin C and (i) between about 100 and about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram and about 150 grams of a Hydrolyzed Collagen Protein.
  • a dose e.g., daily
  • a further aspect of the present invention concerns a method of treatment using a nutritional supplement, the method comprising the step of dispensing to a patient, in tablet form, a dose, e.g., daily, of the supplement including between about 250 milligrams and about 5000 milligrams of Vitamin C and (i) between about 100 and about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram and about 150 grams of a Hydrolyzed Collagen Protein.
  • a dose e.g., daily
  • a method of treatment using a nutritional supplement comprising the step of dispensing to a patient, in gel capsule form, a dose, e.g., daily, of the supplement including between about 250 milligrams and about 5000 milligrams of Vitamin C and (i) between about 100 and about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram and about 150 grams of a Hydrolyzed Collagen Protein.
  • An additional aspect of the present invention relates to a method of treatment using a nutritional supplement, the method comprising the step of dispensing to a patient, in skin patch form, a dose, e.g., daily, of the supplement including between about 250 milligrams and about 5000 milligrams of Vitamin C and (i) between about 100 and about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram and about 150 grams of a Hydrolyzed Collagen Protein.
  • a dose e.g., daily
  • Still a further aspect of the present invention relates to a method of treatment using a nutritional supplement, the method comprising the step of dispensing to a patient, in a powder for reconstitution, a dose, e.g., daily, of the supplement including between about 250 milligrams and about 5000 milligrams of Vitamin C and (i) between about 100 and about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram and about 150 grams of a Hydrolyzed Collagen Protein.
  • a dose e.g., daily
  • a supplemental aspect of the present invention is directed to a method of treatment using a nutritional supplement, the method comprising the step of dispensing to a patient, in a nutritional bar or other food, a dose, e.g., daily, of the supplement including between about 250 milligrams and about 5000 milligrams of
  • Vitamin C and (i) between about 100 and about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram and about 150 grams of a Hydrolyzed Collagen
  • Yet a further aspect of the present invention relates to a nutritional supplement and method of treatment using the same, the supplement comprising Vitamin C, in mixture, with L-Carnitine and or one or more selected proteins in selected proportions so as to provide a synergistic effect and, thereby, optimize their biotransformation and utilization in the body. Accordingly, it is an object of the present invention to provide a nutritional supplement that is highly effective for improving the overall health, comfort, vitality and well being of patients under treatment in hospitals and others in need of nutritional aid. Another object of the present invention is to accommodate the general health and nutritional needs of patients during hospitalization, after surgery and/or during relatively long periods of bed rest. A further object of the present invention is to provide a nutritional supplement particularly well suited for people generally in their later years of life.
  • a further object of the present invention is to provide a novel nutritional supplement in liquid form comprising a mixture of Hydrolyzed Collagen Protein or other Protein source having essential amino acids, L-Carnitine, and Vitamin C for improving the overall health, comfort, vitality, well being, strength and stamina of a patient.
  • Yet a further object of the present invention is to provide a novel nutritional supplement in tablet or gel capsule form comprising a mixture of Hydrolyzed
  • Another object of the present invention is to provide a novel nutritional supplement in a skin patch, a powder for reconstitution, nutritional bar or other food comprising a mixture of Hydrolyzed Collagen Protein or other Protein source having essential amino acids, L-Carnitine, and Vitamin C for improving the overall health, comfort, vitality, well being, strength and stamina of a patient.
  • Yet another object of the present invention is to provide a nutritional supplement for preventing and/or countering the effects of Alzheimer's Disease, Chronic Fatigue Syndrome (CFS), Chronic Kidney Disease, Chronic Muscle Myopathy, Connective Tissue Diseases, Diabetes Mellitus, Dialysis, Dieting, Epilepsy, Heart Diseases, Immune Deficiency, Muscle Atrophy, Old Age, Renal Insufficiency and Stroke.
  • CFS Chronic Fatigue Syndrome
  • Chronic Kidney Disease Chronic Muscle Myopathy
  • Connective Tissue Diseases Diabetes Mellitus
  • Dialysis Dieting
  • Epilepsy Heart Diseases
  • Immune Deficiency Muscle Atrophy
  • Old Age Renal Insufficiency and Stroke.
  • Another object of the present invention is to lower healthcare costs by improving patient care, decreasing the length of stay of patients in the hospital, allocation of nursing hours as well as the rate of re-hospitalization, decreasing the duration of ventilator dependence and the need for physical therapy, lessening the use of curative medications, such as antibiotics, and the use of dressing and skin care products for wound healing, and, thereby, lowering healthcare costs. Still other objects and advantages of the present invention will become apparent from the following description of the preferred embodiments.
  • Proteins are a primary requirement for growth and development of all body tissues. They are also essential for healthy brain tissue, hair, skin and nails. Although critical, Proteins are not normally consumed for energy by the human body when adequate levels of fats and carbohydrates are present. Proteins are relatively large complex molecules that must be broken down into individual components, commonly known as peptides and amino acids, before they can be absorbed and utilized by the body. This process typically occurs in the digestive tract and is the result of a certain enzyme action referred to as hydrolysis. Put another way, Proteins are "hydrolyzed" during digestion into their components, namely, peptides and amino acids. Notably, when the body breaks down Protein, waste products are produced that build up in the blood and become harmful.
  • proteins include, but are not limited to, L-arginine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-threonine, L-valine and mixtures thereof.
  • Such Protein source may comprise, for example, soy protein.
  • Hydrolyzed Collagen Protein is a type of Protein found in virtually all organs of the body, it being the most prevalent Protein in the human body. Predominantly, it is found in the skin, nails, ligaments and bones. Hydrolyzed Collagen Protein is essentially a connective tissue substance. In other words, it is the "cement" that holds everything together. Hydrolyzed Collagen Protein, along with Elastin, are considered the key structural components of bones, cartilage, tendons, skin, lung tissue and blood vessels. Specifically, Hydrolyzed Collagen Protein provides the structure and firmness to body tissues, whereas Elastin is largely responsible for their flexibility.
  • Hydrolyzed Collagen Protein has many known benefits such as aiding the formation and maintenance of bones, skin and cartilage, and maintenance of healthy joints and tendons. Another advantage is that it assists in tissue repair following injury and facilitates healing wounds. It is also useful for muscle spasticity problems and is considered extremely important in brain metabolism. Another important nutrient is L-Carnitine. While found naturally in the body in relatively small quantities, L-Carnitine is a vitamin-like nutrient which maintains normal life functions including energy production and the metabolism of fat. It is also known for supporting healing of many health disorders and generally improving the quality of life. Since the cardiac muscle derives its energy primarily through oxidation of fatty acids, L-Carnitine is particularly important for nourishment of the heart.
  • L-Carnitine supplements have been shown to strengthen the heart and increase cardiac output.
  • L-Carnitine has been shown to increase muscle tissue strength and endurance. It is also well regarded not only for enhancing liver function including improvement of the liver's fat burning process, but also for increasing Protein synthesis. L-Carnitine has even been shown to slow the aging process and to improve cognitive abilities such as concentration, memory and the ability to learn. Consequences of L-Carnitine deficiency include hepatic enzyme derangement and increased risk of fatty liver, severe hypoglycemia, weakness, and risk of electrolyte imbalances, and hypertriglyceridemia including a risk of severe acute pancreatitis.
  • Vitamin C is uniquely important to the health and well-being of humans. It plays a key role as a component of enzymes involved in the natural synthesis of collagen and L-Carnitine in the body. Possibly the most important role of Vitamin C is in the maintenance of a healthy immune system. Specifically, Vitamin C stimulates the immune system and protects against damage by free radicals released by the body in its fight against infection. Medical research has shown that people who suffer from asthma, arthritis, cancer, diabetes, and heart disease have much lower levels of Vitamin C in their blood than do healthy people. It has also been determined that Vitamin C supplements significantly lower the risk of cataracts and glaucoma.
  • Vitamin C deficiency results in increased risk of skin breakdown, prolonged wound healing time, decreased response to and, hence, prolonged duration of infection, iron-deficiency anemia, bleeding gums and other dental problems. It has been found that Vitamin C also plays a key role as a component of enzymes involved in the biosynthesis and utilization of both collagen and L-Carnitine in the body. When small amounts of carnitine and/or Protein are ingested, some utilization of these materials takes place in the body. However, when large amounts of carnitine and/or Protein are ingested without Vitamin C or in the presence of low levels of Vitamin C, much of the carnitine and/or Protein are not utilized by the body and are wasted.
  • a nutritional supplement having, according to one embodiment of the present invention, enhanced Vitamin C fortified with Hydrolyzed Collagen Protein (or Protein Hydrolysate) and/or L-Carnitine for nutritional supplementation.
  • Vitamin C formulated with essential amino acids and/or L-Carnitine so as to optimize the uptake of Vitamin C, L- Carnitine and Protein by the body.
  • Vitamin C is considered to be an essential constituent of the present invention.
  • a nutritional supplement which comprises, preferably in an aqueous-based mixture, Vitamin C or a selected source of Vitamin C generally within a range of 250 milligrams and 1500 milligrams and (i) a selected source of L-Carnitine generally within a range of 500 milligrams and 3000 milligrams, and/or (ii) a selected source of Protein(s) having essential amino acids, such source containing Proteins generally within a range of 7.5 grams and 45.0 grams.
  • Suitable sources of Vitamin C that have been found acceptable include, but are not limited to, Ascorbic Acid, Sodium Ascorbate, Calcium Ascorbate, as well as any salt or ester of Ascorbic Acid.
  • Sources of L-Carnitine include, but are not limited to, L- Acetyl L-Carnitine, L-Carnitine Fumarate, L-Carnitine L-Tartrate, L-Carnitine HCL, and/or any salt or ester of L-Carnitine and mixtures thereof.
  • L- Acetyl L-Carnitine L-Carnitine Fumarate, L-Carnitine L-Tartrate, L-Carnitine HCL, and/or any salt or ester of L-Carnitine and mixtures thereof.
  • Hydrolyzed Collagen Protein is the use of Hydrolyzed Collagen Protein.
  • the composition preferably contains Vitamin C, for example, in bulk powder form as sold by Royal DSM N.V., in sufficient quantities such that a daily dose of the composition contains at least about 250 milligrams of Vitamin C. Alternatively or concurrently, the composition contains between about 250 and about 5000 milligrams of Vitamin C.
  • the composition of the present invention contains Vitamin C in quantities generally within a range of 250 and 3000 milligrams. It has been found that a daily dose containing between about 250 and about 1500 milligrams of Vitamin C is optimal.
  • a daily dose containing between about 250 and about 1500 milligrams of Vitamin C is optimal.
  • the composition of the present invention contains L- Carnitine, or a source thereof, e.g., sold by Lonza Group Ltd. under the trade name Carnipure, in sufficient quantities such that a daily dose of the composition contains between about 100 and about 5000 milligrams of L-Carnitine.
  • the composition of the present invention contains L-Carnitine or a source thereof in quantities generally within a range of 250 and 4000 milligrams.
  • the daily dose contain between about 500 and about 3000 milligrams of L-Carnitine.
  • a Protein source for instance, Hydrolyzed Collagen Protein distributed by P.B. Leiner under the Polypro label
  • the composition contains a Protein source in sufficient quantities such that a daily dose of the composition contains between about 5 and about 100 grams of Protein. It is considered particularly desirable that such daily dose contain generally within a range of 7.5 and 45 grams of Protein.
  • compositions, in accordance with the present invention be consumed by a patient in sufficient quantities and at such concentration that the patient's intake of the operative constituents are as follows: Vitamin C: about 250 to about 5000 milligrams, L-Carnitine: about 100 to about 5000 milligrams, and Protein: about 1 to about 150 grams; or Vitamin C: about 250 to about 5000 milligrams, and L-Carnitine: about 100 to about 5000 milligrams; or Vitamin C: about 250 to about 5000 milligrams, and Protein: about 1 to about 150 grams.
  • compositions are such that daily dosages could be administered through ingestion of between about 1 and about 6 tablespoons of such composition daily. While the present invention is described with reference to such selected dosages in tablespoons, it is understood that any number of tablespoon dosages may be utilized, giving consideration to the purpose for which the present invention is intended.
  • the present invention may be dispensed, as is, in conventional tablet or gel capsule form, in food or a nutritional bar, or may be readily mixed with water or other aqueous-based liquids (e.g., orange juice, grape fruit juice, grape juice, etc.).
  • a specific, illustrative disclosure of food of this type is provided in U.S. Patent No.
  • composition according to the present invention may be mixed with non-aqueous-based liquids or dispensed in a conventional skin patch form in generally lower concentrations, as will be appreciated by those skilled in the art of skin patches.
  • a nutritional type skin patch of this general description may be found, for example, in U.S. Patent No. 6,893,656, entitled ATHLETIC PATCH, which issued on May 15, 2005 to Andrew Blitzer and Terry Pretorius, the disclosure of which is incorporated by reference herein it its entirety.
  • composition of the present invention is distributed, for instance, in an eight (8) fluid ounce container (236.5 milliliters), containing approximately 16 tablespoonful doses of premixed liquid.
  • a further benefit of the present invention is its relatively mild taste. This makes it readily usable with conventional flavorings such as a pleasant tasting orange flavor or the like. Its mild taste also makes it highly versatile for addition to non- citrus beverages, soups, gravies, sauces and other regular menu items to increase Protein intake when such foods can be consumed. Similarly, it is considered suitable for use in electrolyte restricted diets and does not contain sugar, fats, carbohydrates, lactose, gluten, yeast, corn, wheat starch, eggs, fish or dairy.
  • a nutritional supplement formulation is provided in an aqueous-based mixture, the supplement comprising up to about 7.5 grams of Hydrolyzed Collagen Protein (Polypro), about 500 milligrams of L-Carnitine (Carnipure) and about 250 milligrams of Vitamin C (in bulk powder form) in a total volume of about 15 milliliters.
  • the supplement is dispensed in liquid form, in a dosage of one (1) or more tablespoons (or about a 15 milliliter equivalent or more) per day.
  • Each liquid tablespoon provides the following essential amino acids in the approximate amounts expressed in milligrams available: L-Arginine 615 L-Histidine 77 L-Isoleucine 112 L-Leucine 233 L-Lysine 315 L-Methionine 122 L-Phenylalanine 148 L-Threonine 151 L-Valine 175
  • a nutritional supplement formulation is provided in an aqueous-based mixture, the supplement comprising about 15 grams of Hydrolyzed Collagen Protein, about 1000 milligrams of L-Carnitine and about 500 milligrams of Vitamin C.
  • the supplement is dispensed in liquid form, two (2) tablespoons (or about a 30 milliliter equivalent) per day. Each liquid tablespoon provides the following essential amino acids (approximately in milligrams): L-Arginine 1230 L-Histidine 155 L-Isoleucine 224 L-Leucine 466 L-Lysine 630 L-Methionine 244 L-Phenylalanine 296 L-Threonine 302 L-Valine 350
  • a nutritional supplement formulation is provided in an aqueous-based mixture.
  • the supplement comprises about 30 grams of Hydrolyzed Collagen Protein, about 2000 milligrams of L-Carnitine and about 1000 milligrams of Vitamin C.
  • the supplement is dispensed in liquid form, four (4) tablespoons (or about a 60 milliliter equivalent) per day.
  • Each liquid tablespoon provides the following amino acids (approximately in milligrams): L-Arginine 2460 L-Histidine 310 L-Isoleucine 448 L-Leucine 932 L-Lysine 1260 L-Methionine 488 L-Phenylalanine 592 L-Threonine 604 L-Valine 700
  • a nutritional supplement formulation comprising, in an aqueous-based mixture, about 45 grams of Hydrolyzed Collagen Protein, about 3000 milligrams of
  • L-Carnitine and about 1500 milligrams of Vitamin C.
  • the supplement is dispensed to a patient in liquid form, six (6) tablespoons (or about a 90 milliliter equivalent) per day.
  • Each liquid tablespoon provides the following amino acids: L-Arginine 3700 L-Histidine 470 L-Isoleucine 670 L-Leucine 1400 L-Lysine 1890 L-Methionine 730 L-Phenylalanine 890 L-Threonine 910 L-Valine 1050
  • the present invention has been shown and described in connection with a particular carrier for treatment, i.e., in an aqueous-based mixture, it is understood that the composition may be in other forms, whether in a non-aqueous- based mixture, in tablet form, in gel capsule form, in a fluid, or other conventional and non-conventional method of administration, as is practicable, giving consideration to the purpose for which the present invention is intended.
  • the present invention is disclosed with reference to particular ranges of constituents, it will be appreciated that other suitable ranges of ingredients may be utilized, giving consideration to the purpose for which the present invention is intended.
  • the invention is described as containing constituents in relatively high potency levels such as Vitamin C generally within a range of 250 milligrams and 5000 milligrams, other suitable ranges, e.g., between about 100 milligrams and about 1000 milligrams of Vitamin C, may also be used, within the spirit and scope of the present invention.
  • the present invention is provided as a powder for reconstitution prior to administration.
  • the three active ingredients i.e., Protein, L-Carnitine and Vitamin C
  • the three active ingredients are prepared in powder form and blended generally uniformly with selected natural or synthetic conventional flavoring(s) and a conventional sweetener, e.g., non-caloric, also in powder form.
  • a conventional sweetener e.g., non-caloric
  • the resulting uniform powder mix is then packaged in a canister or conventional foil or foil laminate packet and sealed.
  • the packet preferably contains product information, batch number information, and the expiration date of the powder.
  • a patient or healthcare professional simply tears the packet open, adds the powder contents to an appropriate liquid (e.g., water, juice, milk or the like), stirs the same to a uniform blend, and then drinks (or otherwise administers) the liquid.
  • an appropriate liquid e.g., water, juice, milk or the like
  • an appropriate conventional liquid carrier containing the active ingredients of the present invention is used as a transfer medium to be dispensed to the patient through a suitable feeding tube.
  • the nutritional supplement described is particularly useful for providing extra Protein to persons having increased Protein needs or for patients who are unable to meet their daily Protein needs with a normal diet.
  • Such patients include those requiring pre- or post-operative Protein supplementation or nutritional support during cancer therapy; those suffering from chronic kidney disease, in severe burn conditions, and those patients requiring increased Protein due to excessive Protein loss such as in stress and trauma conditions. More particularly, patients suffering from chronic kidney disease with renal insufficiency have higher needs for increased Protein, L-Carnitine and Vitamin C intake.
  • the present invention is an ideal nutritional supplement to oral and tube-fed enteral administered products for patients that require Protein supplementation for a particular clinical condition. It is also useful generally as a highly effective first line of defense or as a support to other therapies as a first step in wellness.
  • the present invention advantageously provides concentrated Protein supplementation in a unique formula including L-Carnitine along with other essential amino acid nutrients, and Vitamin C. It is formulated so as to be easily digestible and, therefore, rapidly absorbed to enhance delivery of its nutritionally balanced contents. In this manner, Amino Acids, L-Carnitine and Vitamin C, which are all important for good nutritional health and well-being, are now available in a unique, concentrated dose that is easy to administer, safe and non-toxic.
  • the present invention provides numerous additional beneficial features including, but not limited to, a composition that is rapidly absorbed by the body in solution, easily digestible such that the amino acid constituents are readily available for absorption, and is well-tolerated by the body with no known side effects, such as diarrhea.
  • the present invention prepared for non-oral administration will not clog patient feeding tubes, has zero carbohydrates, contains no fats, sugar, or phosphorus, and is both lactose free and gluten free.
  • the solution is also pleasant tasting and can be formulated in a wide range of concentrations.
  • compositions include, but are not limited to: muscle atrophy, weakness, disease including muscular dystrophy and ALS, general fatigue and poor endurance; diabetes mellitus; kidney disease and nutritional deficiencies resulting from dialysis; nutritional deficiencies resulting from dieting; lipid abnormalities such as elevated cholesterol and/or triglyceride levels; liver disease; atherosclerosis/heart disease, namely, ischemic heart disease, angina pectoris, and cardiac arrhythmias; immune diseases, suppressed immune system; obesity; burn injuries; Crohn's disease; decubitus ulcers; connective tissue/joint-related diseases including arthritis and sports injuries; individuals on total parenteral nutrition; anemia (by enhancing absorption of ferrous sulfate, and when used in conjunction with Epoetin Alfa therapy, can lead to higher levels of hemoglobin and hematocrit); pancreatic; peri-operative patients; and developmentally delayed babies and children
  • the present invention may also be used to aid in the healing of wounds and to provide a nutritional supplement for preventing and/or countering the effects of Alzheimer's Disease, Chronic Fatigue Syndrome (CFS), Chronic Muscle Myopathy, Connective Tissue Diseases, Epilepsy and Stroke. Additionally, use of the present invention will further lower healthcare costs by improving patient care, decreasing the length of stay of patients in the hospital, allocation of nursing hours as well as the rate of re-hospitalization, decreasing the duration of ventilator dependence and the need for physical therapy, lessening the use of curative medications, such as antibiotics, and the use of dressing and skin care products for wound healing and, thereby, lower healthcare costs.
  • curative medications such as antibiotics

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Abstract

L'invention concerne un complément nutritionnel et une méthode de traitement faisant appel à ce dernier, ce complément comprenant de la vitamine C en quantité généralement comprise entre 250 milligrammes et 5000 milligrammes, en mélange avec de la L-carnitine en quantité généralement comprise entre 100 milligrammes et 5000 milligrammes, et/ou une ou plusieurs protéines qui renferment des acides aminés essentiels et dont la quantité est généralement comprise entre 1 gramme et 150 grammes.
PCT/US2005/020421 2004-06-09 2005-06-09 Composition a base de vitamine c elaboree presentant une biotransformation amelioree et utilisation de proteines et de l-carnitine pour complementation nutritionnelle ou analogue WO2005123108A2 (fr)

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CA002514687A CA2514687A1 (fr) 2004-06-09 2005-06-09 Composition de pointe a base de vitamine c possedant des capacites ameliorees de biotransformation et utilisation de proteines et de l-carnitine comme additifs nutritionnels ou comme substances de meme nature

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EP2508179A1 (fr) * 2011-04-05 2012-10-10 Lonza Ltd. Utilisation de carnitine L, sels et dérivés associés pour réduire ou empêcher la fatigue et améliorer la fonction cognitive
WO2012136699A1 (fr) * 2011-04-05 2012-10-11 Lonza Ltd. Utilisation de l-carnitine, sels et dérivés de celle-ci pour réduire ou prévenir la fatigue et améliorer la fonction cognitive
CN103404572A (zh) * 2013-08-22 2013-11-27 北京康比特体育科技股份有限公司 一种能量补充及缓解疲劳的烘焙棒及其制备方法
WO2014016837A1 (fr) * 2012-07-25 2014-01-30 Oneday - Biotech And Pharma Ltd. Compositions et méthodes permettant d'augmenter le niveau de carnitine dans les tissus musculaires
US9493507B2 (en) 2012-07-23 2016-11-15 Oneday—Biotech And Pharma Ltd. Glutathione-elevating compositions and uses thereof
US9617301B2 (en) 2011-01-20 2017-04-11 Oneday-Biotech and Pharma Ltd. Antioxidant, anti-inflammatory, anti-radiation, metal chelating compounds and uses thereof
JP2018064492A (ja) * 2016-10-18 2018-04-26 株式会社明治 たんぱく質効率向上用の組成物
US10226422B2 (en) 2013-01-23 2019-03-12 Bottled Science Limited Skin enhancing beverage composition
US20190137518A1 (en) * 2017-11-03 2019-05-09 John Burd Inhibiting chronic blood and nephrological disorders using lysine-based supplements
US10653720B2 (en) 2017-11-03 2020-05-19 Lysulin, Inc. Prevention of protein glycation using lysine/zinc supplements
CN111990574A (zh) * 2020-09-18 2020-11-27 内蒙古精晶生物科技有限公司 一种左旋肉碱营养泡腾片
US11045495B2 (en) 2017-11-03 2021-06-29 Lysulin, Inc. Method of improving beta cell function using a supplement
US11077085B2 (en) 2016-08-26 2021-08-03 Atif Dabdoub Dietary macro/micronutritional supplement for patients undergoing kidney dialysis
US11255838B2 (en) 2017-11-03 2022-02-22 Lysulin, Inc. Levels, functions, and resistances related to chronic conditions by using lysine-based supplements

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Cited By (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9617301B2 (en) 2011-01-20 2017-04-11 Oneday-Biotech and Pharma Ltd. Antioxidant, anti-inflammatory, anti-radiation, metal chelating compounds and uses thereof
WO2012136699A1 (fr) * 2011-04-05 2012-10-11 Lonza Ltd. Utilisation de l-carnitine, sels et dérivés de celle-ci pour réduire ou prévenir la fatigue et améliorer la fonction cognitive
EP2508179A1 (fr) * 2011-04-05 2012-10-10 Lonza Ltd. Utilisation de carnitine L, sels et dérivés associés pour réduire ou empêcher la fatigue et améliorer la fonction cognitive
US9493507B2 (en) 2012-07-23 2016-11-15 Oneday—Biotech And Pharma Ltd. Glutathione-elevating compositions and uses thereof
WO2014016837A1 (fr) * 2012-07-25 2014-01-30 Oneday - Biotech And Pharma Ltd. Compositions et méthodes permettant d'augmenter le niveau de carnitine dans les tissus musculaires
EP2877194A4 (fr) * 2012-07-25 2016-03-16 Oneday Biotech And Pharma Ltd Compositions et méthodes permettant d'augmenter le niveau de carnitine dans les tissus musculaires
US9499582B2 (en) 2012-07-25 2016-11-22 Genesistec Ltd. Compositions and methods for increasing carnitine level in muscle tissue
US10226422B2 (en) 2013-01-23 2019-03-12 Bottled Science Limited Skin enhancing beverage composition
CN103404572A (zh) * 2013-08-22 2013-11-27 北京康比特体育科技股份有限公司 一种能量补充及缓解疲劳的烘焙棒及其制备方法
US11077085B2 (en) 2016-08-26 2021-08-03 Atif Dabdoub Dietary macro/micronutritional supplement for patients undergoing kidney dialysis
JP2018064492A (ja) * 2016-10-18 2018-04-26 株式会社明治 たんぱく質効率向上用の組成物
WO2018074415A1 (fr) * 2016-10-18 2018-04-26 株式会社明治 Composition pour améliorer le coefficient d'efficacité protéique
US20190137518A1 (en) * 2017-11-03 2019-05-09 John Burd Inhibiting chronic blood and nephrological disorders using lysine-based supplements
US10466256B2 (en) * 2017-11-03 2019-11-05 Lysulin, Inc. Inhibiting chronic blood and nephrological disorders using lysine-based supplements
US10653720B2 (en) 2017-11-03 2020-05-19 Lysulin, Inc. Prevention of protein glycation using lysine/zinc supplements
US10656166B2 (en) 2017-11-03 2020-05-19 Lysulin, Inc. Inhibiting chronic blood and nephrological disorders using lysine-based supplements
US10980834B2 (en) 2017-11-03 2021-04-20 Lysulin, Inc. Prevention of protein glycation using lysine supplements
US11045495B2 (en) 2017-11-03 2021-06-29 Lysulin, Inc. Method of improving beta cell function using a supplement
US11255838B2 (en) 2017-11-03 2022-02-22 Lysulin, Inc. Levels, functions, and resistances related to chronic conditions by using lysine-based supplements
CN111990574A (zh) * 2020-09-18 2020-11-27 内蒙古精晶生物科技有限公司 一种左旋肉碱营养泡腾片

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