# US 2013/0157937 A1 · Stable high lipid liquid formula

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- Number: US 2013/0157937 A1
- Document ID: US20130157937A1
- Status: Published application
- Kind: A1
- Application number: 13/701,794
- Filed: 2011-06-06
- Published: 2013-06-20
- Earliest claimed: 2010-06-04
- Assignees: N.V. Nutricia
- Inventors: Andrew Sean Lynch; Simon Anders; Paul Ronald
- Web page: https://patentgrep.com/patent/US20130157937A1

## CPC

- A61K 9/107: Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)}
- A23L 33/115: Fatty acids or derivatives thereof; Fats or oils
- A23L 33/12: Fatty acids or derivatives thereof
- A23L 33/19: Dairy proteins
- A23L 33/21: Addition of substantially indigestible substances, e.g. dietary fibres
- A23L 33/22: Comminuted fibrous parts of plants, e.g. bagasse or pulp
- A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula}
- A61K 31/20: having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61K 31/733: Fructosans, e.g. inulin
- A61K 36/48: Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K 38/018: {from milk}
- A61K 38/1709: {from mammals}
- A61P 1/10: Laxatives
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 25/08: Antiepileptics; Anticonvulsants
- A61P 25/16: Anti-Parkinson drugs
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 35/00: Antineoplastic agents
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

The present invention provides a ketogenic diet in the form of a sterile shelf stable ready to use formula, in particular a tube feed, comprising casein and dietary fibre.

## Claims

### Claim at position 1

1-13. (canceled)

### Claim 14

A sterile liquid composition having a caloric density between 1 and 4 kcal/ml, comprising lipid, protein, digestible carbohydrates and dietary fibers, wherein:
(a) the lipid provides at least 80% of the total calories of the composition and comprises at least 65% of unsaturated fatty acids on total fatty acids present in the composition,
(b) the protein comprises at least 0.15 g casein per g lipid of the composition, and
(c) the dietary fiber comprises at least two selected from the group consisting of resistant starch, inulin and soy fiber in an amount of at least 0.3 g per 100 ml of the composition.

### Claim 15 (depends on 14)

The sterile liquid composition according to claim 14, having a pH between 6.5 and 7.6.

### Claim 16 (depends on 14)

The sterile liquid composition according to claim 14, wherein the protein comprises between 1 and 3 g casein per 100 ml.

### Claim 17 (depends on 14)

The sterile liquid composition according to claim 14, wherein the dietary fiber comprises resistant starch, inulin and soy fiber.

### Claim 18 (depends on 14)

The sterile liquid composition according to claim 14, wherein the casein is sodium caseinate.

### Claim 19 (depends on 14)

The sterile liquid composition according to claim 14, wherein the caloric density is between 1.4 and 2.0 kcal/ml.

### Claim 20 (depends on 14)

The sterile liquid composition according to claim 14, wherein the lipid comprises at least 70% unsaturated fatty acids based on total fatty acids present in the composition.

### Claim 21 (depends on 14)

The sterile liquid composition according to claim 14, wherein the composition further comprises one or more selected from:
(i) 0.001-0.1 g/100 ml propylene glycol alginate,
(ii) 0.05-0.80 g/100 ml citric acid esters of mono and diglycerides of fatty acids, and
(iii) 0.001 and 0.50 g/100 ml glyceryl monostearate and glyceryl distearate.

### Claim 22 (depends on 14)

The sterile liquid composition according to claim 14, which is a shelf-stable tube feed.

### Claim 23 (depends on 14)

The sterile liquid composition according to claim 14, having a weight ratio (cascin+fiber): lipid between 0.12 and 0.40.

### Claim 24 (depends on 14)

A method for the nutritional management of patients experiencing epileptic syndromes, seizures and myoclonic jerk, persons in need of improvement-of cognitive skills, patients suffering from Alzheimer's Disease, patients which suffer from a tumor or amyotrophic lateral sclerosis, patients suffering from Parkinson's disease or stroke or brain trauma or diabetes or obesity, the method comprising administering to the persons or patients an effective amount of the sterile liquid composition according to claim 14.

### Claim 25 (depends on 14)

A method for the treatment of a patient suffering from epilepsy, a patient suffering from gut motility disorders including constipation, a patient suffering from Alzheimer's Disease, or a patient suffering from a tumor, the method comprising administering to the patient an effective amount of the sterile liquid composition according to claim 14.

### Claim 26 (depends on 14)

A method for the prevention of epileptic seizures, comprising administering to a patient in need thereof an effective amount of the sterile liquid composition according to claim 14.