# US 11,992,036 B2 · Fasting condition as dietary treatment of diabetes

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- Number: US 11,992,036 B2
- Document ID: US11992036B2
- Status: Granted
- Kind: B2
- Application number: 17/162,809
- Filed: 2021-01-29
- Published: 2021-05-20
- Granted: 2024-05-28
- Earliest claimed: 2013-07-01
- Assignees: University of Southern California
- Applicants: University of Southern California
- Inventors: Valter D. Longo; Chia-Wei Cheng
- Web page: https://patentgrep.com/patent/US11992036B2

## CPC

- A23L 33/30: {Dietetic or nutritional methods, e.g. for losing weight (A23L33/10 takes precedence)}
- A23L 33/115: Fatty acids or derivatives thereof; Fats or oils
- A23L 33/17: Amino acids, peptides or proteins
- A23L 33/20: Reducing nutritive value; Dietetic products with reduced nutritive value
- A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula}
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/08: for glucose homeostasis (pancreatic hormones A61P5/48)
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- 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

A method of alleviating symptoms of, or treating, pancreatic beta-cell damage in a subject includes a step of identifying a subject having pancreatic beta-cell damage. Multiple cycles of a diet protocol are administered to the subject. The diet protocol includes administering of a fasting mimicking diet and a re-feeding diet where the fasting mimicking diet is provided for a first time period and the re-feeding diet is provided for a second time period.

## Claims

### Claim 1

A diet package for administering a fasting mimicking diet, the diet package comprising:
rations for the fasting mimicking diet to be administered for a first time period to a subject, the first time period including a first day, a second day, a third day, a fourth day, and a fifth day, the rations for the fasting mimicking diet providing less than about 50% of the normal caloric intake of the subject wherein the rations for the fasting mimicking diet includes protein in an amount that is less than 15 percent of total calories provided by the rations for the fasting mimicking diet and sugars in an amount that is less than 15 percent of total calories provided by the rations for the fasting mimicking diet, the rations providing less than 12 g of saturated fats on the first day and less than 6 grams of saturated fats on the second to fifth days.

### Claim 2 (depends on 1)

The diet package of claim 1, wherein the diet package includes rations for 2 to 6 days.

### Claim 3 (depends on 1)

The diet package of claim 1, wherein the diet package includes rations for 4 or 5 days.

### Claim 4 (depends on 1)

The diet package of claim 1, wherein the rations for the fasting mimicking diet provides from 4.5 to 7 kilocalories per pound of subject for the first day and 3 to 5 kilocalories per pound of subject per day for a second to fifth days, the fasting mimicking diet being a low protein diet that provides less than 28 g of proteins on the first day and less than 18 g of proteins on the second to fifth wherein the rations provide less than 30 g of sugar on the first day, less than 20 g of sugar on the second to fifth days, 20 to 30 grams of monounsaturated fats on the first day and 10 to 15 grams of monounsaturated fats on the second to fifth days.

### Claim 5 (depends on 1)

The diet package of claim 1, wherein the rations provide between 6 and 10 grams of polyunsaturated fats on the first day and 3 to 5 grams of polyunsaturated fats on the second to fifth days.

### Claim 6 (depends on 1)

The diet package of claim 1, wherein the rations provide 2 to 5% calories from glycerol.

### Claim 7 (depends on 1)

The diet package of claim 1, wherein the rations provide at least 60% calories from fatty acids, 2-5% calories from glycerol, up to 5% of calories from plant-based proteins, and a maximum of 35% of calories from carbohydrates.

### Claim 8 (depends on 1)

The diet package of claim 1, wherein the rations provide 12 to 25 grams of glycerol per day on the second to fifth days.

### Claim 9 (depends on 1)

The diet package of claim 1, wherein the rations provide over 5,000 IU of vitamin A per day for days 1-5 and 60-240 mg of vitamin C per day for days 1-5.

### Claim 10 (depends on 9)

The diet package of claim 9, wherein the rations provide 400-800 mg of calcium per day for days 1-5; 7.2-14.4 mg of iron per day for days 1-5; 200-400 mg of magnesium per day for days 1-5; 1-2 mg of copper per day for days 1-5; 1-2 mg of manganese per day for days 1-5; and 3.5-7 mcg of selenium per day for days 1-5.

### Claim 11 (depends on 9)

The diet package of claim 9, wherein for a five-day period, the rations provide 2-4 mg of Vitamin B1 per day for days 1-5; 2-4 mg of Vitamin B2 per day for days 1-5; 20-30 mg of Vitamin B3 per day for days 1-5; 1-1.5 mg of Vitamin B5 per day for days 1-5; 2-4 mg of Vitamin B6 per day for days 1-5; 240-480 mcg of Vitamin B9 per day for days 1-5; 600-1000 IU of Vitamin D per day for days 1-5; 14-30 mg of Vitamin E per day for days 1-5; over 80 mcg of Vitamin K per day for days 1-5; and 16-25 mcg Vitamin B12 are provided during the 5-day period.

### Claim 12 (depends on 9)

The diet package of claim 9, wherein the rations provide 600 mg of docosahexaenoic acid during the 5 day period.

### Claim 13

A diet package for administering a fasting mimicking diet, the diet package comprising:
rations for the fasting mimicking diet to be administered for a first time period to a subject, the first time period including a first day, a second day, a third day, a fourth day, and a fifth day, the rations for the fasting mimicking diet providing less than about 50% of the normal caloric intake of the subject wherein the rations for the fasting mimicking diet includes protein in an amount that is less than 15 percent of total calories provided by the rations for the fasting mimicking diet and sugars in an amount that is less than 15 percent of total calories provided by the rations for the fasting mimicking diet, the rations providing less than 12 g of saturated fats on the first day and less than 6 grams of saturated fats on the second to fifth days and wherein the diet package includes rations for 4 or 5 days.

### Claim 14 (depends on 13)

The diet package of claim 13, wherein the rations provide 2 to 5% calories from glycerol.

### Claim 15 (depends on 13)

The diet package of claim 13, wherein the rations provide at least 60% calories from fatty acids, 2-5% calories from glycerol, up to 5% of calories from plant-based proteins, and a maximum of 35% of calories from carbohydrates.

### Claim 16 (depends on 13)

The diet package of claim 13, wherein the rations provide over 5,000 IU of vitamin A per day for days 1-5 and 60-240 mg of vitamin C per day for days 1-5.

### Claim 17 (depends on 13)

The diet package of claim 13, wherein the rations provide 400-800 mg of calcium per day for days 1-5; 7.2-14.4 mg of iron per day for days 1-5; 200-400 mg of magnesium per day for days 1-5; 1-2 mg of copper per day for days 1-5; 1-2 mg of manganese per day for days 1-5; and 3.5-7 mcg of selenium per day for days 1-5.

### Claim 18 (depends on 13)

The diet package of claim 13, wherein the rations provide 600 mg of docosahexaenoic acid during the 5-day period.

### Claim 19 (depends on 1)

A method of alleviating a symptom of diabetes, the method administering the diet package of claim 1 to the subject when the subject is identified as exhibiting symptoms caused by pancreatic beta cell destruction.

### Claim 20 (depends on 1)

A method of alleviating insulin resistance and/or hyperglycemia, the method administering the diet package of claim 1 to the subject when the subject is identified as having or being predisposed to insulin resistance and/or fasting hyperglycemia diabetes.