Fasting mimicking diet (FMD) as an immunoregulatory treatment for gastrointestinal autoimmune/inflammatory diseases

1. A method for treating autoimmune and/or inflammatory disease, the method comprising:

a) administering a fasting mimicking diet (FMD) for a first time period to a subject having ulcerative colitis, the first time period being 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 days, wherein the fasting mimicking diet provides from 4.5 to 7 kilocalories per pound of subject for a first day of the fasting mimicking diet, wherein on day 1, the fasting mimicking diet provides less than 30 grams of sugar, less than 28 grams of protein, 20-30 grams of monounsaturated fats, 6-10 grams of polyunsaturated fats and 2-12 grams of saturated fats and on days 2-5 the fasting mimicking diet provides less than 20 grams of sugar, less than 18 grams of protein, 10-15 grams of monounsaturated fats, 3-5 grams of polyunsaturated fats and 1-6 grams of saturated fats.

2. The method of claim 1 wherein the hypocaloric or calorie free diet or fasting mimicking diet is administered for a period of 5 days every 2-12 weeks.

3. The method of claim 1 wherein step a) is repeated a plurality of times at predetermined intervals.

4. The method of claim 3 wherein step a) is repeated at intervals from one week to 6 months.

5. The method of claim 3 wherein the subject is administered a normal diet in between repetition of step a).

6. The method of claim 1 wherein the FMD provides 3-5 kilocalories per pound of subject per day for a second day to the final day of the fasting mimicking diet.

7. The method of claim 1 wherein the FMD also provides vitamin A in an amount of 900-1600 IU; ascorbic acid in an amount of 10-20 mg;

calcium carbonate in an amount of 60-100 mg; ferrous fumarate in an amount of 3-6 mg;

cholecalciferol in an amount of 0.001-0.005 mg; dl-alpha tocopheryl acetate in an amount 3-7 mg; phytonadione in an amount of 0.1-0.04 mg; thiamine mononitratein an amount of 0.15-0.5 mg; riboflavin in an amount 0.2-0.6 mg; and niacinamide in an amount of 3-7 mg.

8. The method of claim 1 wherein the FMD is administered for only 1 day with a frequency of at least 1 day/week every week of a month.

9. The method of claim 1 wherein the FMD will substitute a subject's normal diet for a period of 2 days every week.

10. The method of claim 1 wherein a day 1 FMD diet contains less than 30 grams of sugar, less than 28 grams of protein, 20-30 grams of monounsaturated fats, 6-10 grams of polyunsaturated fats and 2-12 grams of saturated fats.

11. The method of claim 10 wherein a day 2 FMD diet includes less than 20 grams of sugar, less than 18 grams of protein, 10-15 grams of monounsaturated fats, 3-5 grams of polyunsaturated fats and 1-6 grams of saturated fats.

12. The method of claim 11 wherein the FMD also provides vitamin A in an amount of 900-1600 IU; ascorbic acid in an amount of 10-20 mg; calcium carbonate in an amount of 60-100 mg; ferrous fumarate in an amount of 3-6 mg; cholecalciferol in an amount of 0.001-0.005 mg; dl-alpha tocopheryl acetate in an amount 3-7 mg; phytonadione in an amount of 0.1-0.04 mg; thiamine mononitratein an amount of 0.15-0.5 mg; riboflavin in an amount 0.2-0.6 mg; and niacinamide in an amount of 3-7 mg.

13. The method of claim 1 wherein the fasting mimicking diet is administered as a first set of rations providing:

less than 40 grams of sugar for day 1;

less than 30 grams of sugar for days 2 to 5 and any remaining days;

less than 28 grams of protein for day 1;

less than 18 grams of protein for days 2 to 5 and any remaining days;

20-100 grams of monounsaturated fats for day 1;

6-30 grams of polyunsaturated fats for day 1;

2-12 grams of saturated fats for day 1;

10-50 grams of monounsaturated fats for days 2 to 5 and any remaining days;

3-15 grams of polyunsaturated fats for days 2 to 5 and any remaining days;

1-12 grams of saturated fats for days 2 to 5, or any remaining days; and

a micronutrient composition on each day and any remaining days.

14. The method of claim 13 wherein the fasting mimicking diet provides:

8-10 kcal per kilogram body weight for each diet day:

less than 30 grams of sugar for each diet day;

less than 18 grams of protein for each diet day; and

9-15 grams of monounsaturated fats for each diet day, 2.5-4.5 grams of polyunsaturated fats for each diet day and 1-5.5 grams of saturated fats for each diet day.

15. The method of claim 13 wherein the fasting mimicking diet provides:

less than 20 grams of sugar for each diet day;

less than 12 grams of protein for each diet day; and

6.5-10 grams of monounsaturated fats for each diet day, 2.5-4.5 grams of polyunsaturated fats for each diet day and 1.5-4 grams of saturated fats for each diet day.

16. The method of claim 13 wherein the fasting mimicking diet includes Vitamin A in an amount of 900-1600 IU; Ascorbic Acid in an amount of 10-20 mg; calcium carbonate in an amount of 60-100 mg; ferrous fumarate in an amount of 3-6 mg; cholecalciferol in an amount of 0.001-0.005 mg; dl-alpha tocopheryl acetate in an amount 3-7 mg; phytonadione in an amount of 0.1-0.04 mg; thiamine mononitrate in an amount of 0.15-0.5 mg; riboflavin in an amount 0.2-0.6 mg; and niacinamide in an amount of 3-7 mg.

17. The method of claim 16 wherein the fasting mimicking diet includes calcium pantothenate in an amount of 1.5-4.0 mg; pyridoxine hydrochloride in an amount of 0.3-0.7 mg; biotin in an amount of 0.01-0.02 mg; folic acid in an amount of 0.07-0.14 mg; cyanocobalamin in an amount of 0.001-0.002 mg; chromium picolinate in an amount of 0.014-0.022 mg; cupric sulfate in an amount of 0.18-0.32 mg; potassium iodide in an amount of 0.03-0.045 mg; magnesium oxide in an amount of 20-32 mg; manganese sulfate of 0.3-0.7 mg; sodium molybdate in an amount of 0.014-0.023 mg; sodium selenate in an amount of 0.014-0.023 mg; and zinc oxide in an amount of 3-5 mg.

18. The method of claim 13 further comprising a second set of rations for a second diet to be administered to the subject for a second time period, the second diet providing an overall calorie consumption that is within 10 percent of a subject's normal calorie consumption for 25 to 26 days following the fasting mimicking diet.

19. The method of claim 1 wherein the fasting mimicking diet is administered in a sufficient number of cycles to reduce dendritic cells, macrophages, B-lymphocytes, CD4+Th1, and CD4+Th17 cell populations and to increase anti-inflammatory regulatory T cells.