IP Library › Granted Patent US 12,186,352
Granted Patent B2
US 12,186,352 · App. 17/982,067 · Granted Jan 7, 2025

Fasting-mimicking diet (FMD) but not water-only fasting promotes reversal of inflammation and IBD pathology

Inventors: Valter D. Longo (Playa del Rey, CA); Min Wei (West Covina, CA); Priya Rangan (Los Angeles, CA)
Assignee: University of Southern California
A61K35/747A23L3/44A23L33/135A61K9/16A61K9/48A61K35/745A61K2035/115A61K45/06
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Quick Facts
Patent No.
US 12,186,352
App. No.
17/982,067
Granted
Jan 7, 2025
Kind
B2
Abstract

A method for treating autoimmune and/or inflammatory disease includes a step of identifying a subject exhibiting symptoms of autoimmune and/or inflammatory disease administering a fasting mimicking diet. A probiotic composition for gastrointestinal autoimmune and/or inflammatory disease Bacteroides acidifaciens, Bifidobacterium choerinum , and combinations thereof is also provided.

Claims (13)

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

identifying a subject exhibiting symptoms of autoimmune and/or inflammatory disease; and

administering a fasting mimicking diet for a first predetermined time period, the fasting mimicking diet providing the subject with at most 50% to 75% of the subject's normal caloric intake, wherein a probiotic composition is administered to the subject during the first predetermined time period, the probiotic composition comprising:

one or more bacterial components selected from the group consisting of Bacteroides acidifaciens, Bifidobacterium choerinum , and combinations thereof; and

a protective component that stabilizes the one or more bacterial components.

2. The method of claim 1 wherein the fasting mimicking diet provides at most 50% of a subject's normal caloric intake and at least 5% of the subject's normal caloric intake.

3. The method of claim 1 wherein the fasting mimicking diet provides at most 1500 kcal/day and at least 800 kcal/day.

4. The method of claim 1 wherein the fasting mimicking diet is administered for 2 or more cycles.

5. The method of claim 1 , wherein the one or more bacterial components further comprises gut microbiota strains isolated from genera selected from the group consisting of Lactobacillus, Allobaculum, Bifidobacterium , and combinations thereof.

6. The method of claim 5 wherein each bacterial component is present in an amount from about 10 3 to about 10 14 CFU/g.

7. The method of claim 1 , wherein the protective component is selected from the group consisting of protective carriers, protective coating, and protective encapsulants.

8. The method of claim 1 , wherein the fasting mimicking diet is provided from a meal package that includes daily meal portions that provide 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, 20-30 grams of monounsaturated fats or more to reach a desired caloric intake for day 1, 6-10 grams of polyunsaturated fats or more to reach a desired caloric intake for day 1, 2-12 grams of saturated fats or more to reach a desired caloric intake for day 1, 10-15 grams of monounsaturated fats or more to reach a desired caloric intake for days 2 to 5 and any remaining days, 3-5 grams of polyunsaturated fats or more to reach a desired caloric intake for days 2 to 5 and any remaining days, 1-6 grams of saturated fats or more to reach a desired caloric intake for days 2 to 5 and any remaining days.

9. The method of claim 1 wherein the autoimmune and/or inflammatory disease is selected from the group consisting of Crohn's disease, ulcerative colitis, irritable bowel syndrome, celiac disease, microscopic colitis, and Behcet disease.

Assignments (1)
CONFIRMATORY LICENSE Recorded Aug 2, 2023
From: UNIVERSITY OF SOUTHERN CALIFORNIA
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 064476/0114 →
Continuity (5)
Division 16976952
Provisional Application 62735147 · Sep 23, 2018
Provisional Application 62734475 · Sep 21, 2018
Provisional Application 62643296 · Mar 15, 2018
Related Publication 20230078881A1 · Mar 16, 2023
References Cited (81)
US 8211700B2 · Longo · 2012 [cited by applicant]
US 8728815B2 · Longo · 2014 [cited by applicant]
US 8865646B2 · Longo · 2014 [cited by applicant]
US 9044497B2 · Harel et al. · 2015 [cited by applicant]
US 9237761B2 · Longo et al. · 2016 [cited by applicant]
US 9386790B2 · Longo et al. · 2016 [cited by applicant]
US 10015980B2 · Longo et al. · 2018 [cited by applicant]
US 10172839B2 · Longo et al. · 2019 [cited by applicant]
US 10246446B2 · Longo et al. · 2019 [cited by applicant]
US 10433576B2 · Longo et al. · 2019 [cited by applicant]
US 10660932B2 · Longo et al. · 2020 [cited by applicant]
US 20030044946A1 · Longo · 2003 [cited by applicant]
US 20070122397A1 · Sanguansri et al. · 2007 [cited by applicant]
US 20070134391A1 · Prakash et al. · 2007 [cited by applicant]
US 20110118528A1 · Longo et al. · 2011 [cited by applicant]
US 20130045215A1 · Longo et al. · 2013 [cited by applicant]
US 20130316948A1 · Longo · 2013 [cited by applicant]
US 20140112909A1 · Longo · 2014 [cited by examiner]
US 20140328863A1 · Longo · 2014 [cited by applicant]
US 20150133370A1 · Longo · 2015 [cited by applicant]
US 20160220620A1 · Mazo et al. · 2016 [cited by applicant]
US 20160271188A1 · Berry et al. · 2016 [cited by applicant]
US 20160303056A1 · Longo et al. · 2016 [cited by applicant]
US 20160324193A1 · Longo et al. · 2016 [cited by applicant]
US 20160331016A1 · Longo et al. · 2016 [cited by applicant]
US 20170027217A1 · Longo et al. · 2017 [cited by applicant]
US 20170035093A1 · Longo et al. · 2017 [cited by applicant]
US 20170035094A1 · Longo et al. · 2017 [cited by applicant]
US 20170232053A1 · Longo et al. · 2017 [cited by applicant]
US 20170296600A1 · Rangavajla · 2017 [cited by applicant]
US 20170325493A1 · Longo et al. · 2017 [cited by applicant]
US 20170333492A1 · Kweon et al. · 2017 [cited by applicant]
US 20180228198A1 · Longo et al. · 2018 [cited by applicant]
US 20190029301A1 · Longo et al. · 2019 [cited by applicant]
US 20190276445A1 · Longo et al. · 2019 [cited by applicant]
US 20190285640A1 · Longo · 2019 [cited by applicant]
US 20200029614A1 · Longo et al. · 2020 [cited by applicant]
US 20210137149A1 · Brandhorst et al. · 2021 [cited by applicant]
JP 2007507209 · 2007 [cited by applicant]
JP 2009522280 · 2009 [cited by applicant]
KR 20160066724A · 2016 [cited by applicant]
KR 20170058710A · 2017 [cited by applicant]
WO 2004023880A1 · 2004 [cited by applicant]
WO 2011050302 · 2011 [cited by applicant]
WO 2017032739A1 · 2017 [cited by applicant]
WO 2017212433A1 · 2017 [cited by applicant]
Xu, X. et al., “Effects of cyclophosphamide on immune system and gut microbia in mice,” Microbiological Research 171 (2015), pp. 97-106. [cited by applicant]
Longo, V.D. et al., U.S. Appl. No. 17/009,382, filed Sep. 1, 2020, 71 pgs. [cited by applicant]
Kohl, K. et al., Unique and shared responses of the gut microbiota to prolonged fasting: a comparative study across five classes of vertebrate hosts, FEMS Microbiology Ecology, v. 90, n. 3, 2014, pp. 883-894. [cited by applicant]
Schwab, C. et al., Longitudinal study of murine microbiota activity and interactions with the host. [cited by applicant]
Shiga, H. et al., “S1227 The Changes of Fecal Microbiota in Patients with Crohn's Disease During Elemental Diet,” Gastroenterology, v. 134, n. 4, 2008, Abstract only, 1 pg. [cited by applicant]
Yeom, Y. et al., “Leaf extract regulates microbial dysbiosis by modulating the composition and diversity of the microbiota in destran sulfate sodium-induced colitis mice,” BMC Complementary and Alternative Medicine, v. … [cited by applicant]
Supplementary EP Search Report dated Nov. 17, 21 for EP Appn. No. 19767587.9, 20 pgs. [cited by applicant]
Mintel Foodis, Anonymous: “Foodis Pure Organic Baby Formula,” GNPD (2004) 3 pages. [cited by applicant]
Farzaej, M.H. et al., “A mechanistic review of plant-derived natural compounds as dietary supplements for prevention of inflammatory bowel disease,” Expert Review of Gastroenterology & Hepatology (2016), vol. 10, No. 6,… [cited by applicant]
Van der Ark, K.C.H. et al., “Encapsulation of the therapeutic microbe Akkermansia Muciniphila in a double emulsion enhances survival in simulated gastric conditions,” Food Research Int'l., 102 (2017), pp. 372-379. [cited by applicant]
Martinez-Herrero, S. et al., “Lack of Adrenomedullin Results in Microbiota Changes and Aggravates Azoxymethane and Dextran Sulfate Sodium-Induced Colitis in Mice,” Frontiers in Physiology (2016), vol. 7, Article 595, 14… [cited by applicant]
Maxwell, F.J. et al., “Isolation, growth on prebiotics and probiotic potential of novel bifidobacteria from pigs,” Anaerobe 10 (2004), pp. 33-39. [cited by applicant]
Morais, R.M.S.C. et al., “Functional Dehydrated Foods for Health Preservation,” J. of Food Quality, vol. 2018, Article D 739636, (2018), 29 pages. [cited by applicant]
Nematgorgani, S. et al., “Effects of Urtica dioica leaft extract on inflammation, oxidative stress, ESR, blood cell count and quality of life in patients with inflammatory bowel disease,” Journal of Herbal Medicine 9 (2… [cited by applicant]
Otari, K.V. et al., “Protectiv effect of queous extract of [cited by applicant]
Shiba, T. et al., “The Suppresive Effect of Bifidobacteria on Bacteroides Vulgatus, a Putative Pathogenic Microbe in Inflammatory Bowel Disease,” Microbiol. Immunol., vol. 47(6), (2003), pp. 371-378. [cited by applicant]
Toumi, R. et al., “Probiotic Bacteria Lactobacillus and Bifidobacterium Attenuate Inflammation in Dextran Sulfate Sodium-Induced Experimental Colitis in Mice,” Int'l J. of Immunopathology and Pharmacology, vol. 27, No. … [cited by applicant]
European Search Report for EP 19767587.9 dated Mar. 30, 2022, 44 pages. [cited by applicant]
Brandhorst, S. et al., “Short-term calorie and protein restriction provide partial protection from chemotoxicity but do not delay glioma progression,” Experimental Gerontology 48 (2013), pp. 1120-1128. [cited by applicant]
Brandhorst, S. et al., “A Periodic Diet that Mimics Fasting Promotes Multi-System Regeneration, Enhanced Cognitive Performance, and Healthspan,” Cell Metabolism 22, Jul. 7, 2015, pp. 86-99. [cited by applicant]
Cheng, C.-W. et al., “Prolonged Fasting Reduces IGF-1/PKA to Promote Hematopoietic-Stem-Cell-Based Regeneration and Reverse Immunosuppression,” Cell Stem Cell 14, Jun. 5, 2014, pp. 810-823. [cited by applicant]
Cheng, C.-W. et al., “Fasting-Mimicking Diet Promotes Ngn3-Driven Beta-Cell Regeneration to Reverse Diabetes,” Cell 168 (2017), pp. 775-788. [cited by applicant]
Choi, I.Y. et al., “A Diet Mimicking Fasting Promotes Regeneration and Reduces Autoimmunity and Multiple Sclerosis Symptoms,” Cell Reports 15, Jun. 7, 2016, pp. 2136-2146. [cited by applicant]
Di Biase, S. et al., “Fasting-Mimicking Diet Reduces HO-1 to Promote T Cell-Mediated Tumor Cytotoxicity,” Cancer Cell 30, Jul. 11, 2016, pp. 136-146. [cited by applicant]
Di Biase, S. et al., “Fasting regulates EGR1 and protects from glucose- and dexamethasone-dependent sensitization to chemotherapy,” PLOS Biology, Mar. 30, 2017, pp. 1-21. [cited by applicant]
Guevara-Aguirre, J. et al., “Growth Hormone Receptor Deficiency is Associated with a Major Reduction in Pro-Aging Signaling, Cancer, and Diabetes in Humans,” Aging, v. 3, issue 70, Feb. 16, 2011, 11 pgs. [cited by applicant]
Lee, C. et al., “Reduced Levels of IGF-I Mediate Differential Protection of Normal Cancer Cells in Response to Fasting and Improve Chemotherapeutic Index,” Cancer Res., 70(4), Feb. 15, 2010, pp. 1564-1572. [cited by applicant]
Lee, C. et al., “Fasting Cycles Retard Growth of Tumors and Sensitize a Range of Cancer Cell Types to Chemotherapy,” Cancer, v. 4, issue 124, Mar. 7, 2012, 12 pgs. [cited by applicant]
Levine, M.E. et al., “Low Protein Intake is Associated with a Major Reduction in IGF-1, Cancer and Overall Mortality in the 65 and Younger but Not Older Population,” Cell Metabolism 19, Mar. 4, 2014, pp. 407-417. [cited by applicant]
Raffaghello, L. et al., “Starvation-dependent differential stress resistance protects normal but not cancer cells against high-dose chemotherapy,” PNAS, v. 105, n. 24, Jun. 17, 2008, pp. 8215-8220. [cited by applicant]
Rangan, P. et al., “Fasting-Mimicking Diet Modulates Microbiota and Promotes Intestinal Regeneration to Reduce Inflammatory Bowel Disease Pathology,” Cell Reports 26, Mar. 5, 2019, pp. 2704-2719. [cited by applicant]
Wei, M. et al., “Fasting-mimicking diet and markers/risk factors for aging, diabetes, cancer, and cardiovascular disease,” Sci. Transl. Med. 9, Feb. 15, 2017, 13 pgs. [cited by applicant]
International Search Report and Written Opinion dated Jul. 2, 2019 for PCT/US2019/022488, 24 pgs. [cited by applicant]
Xi, G. et al., “Distinctly altered gut microbiota in the progression of liver disease,” Oncotarget, v. 7, n. 15, 2016, pp. 19355-19366. [cited by applicant]
Office Action dated Oct. 25, 2022 for Chinese Appn. No. 2019800195763 filed Sep. 15, 2020, 5 pgs (English translation). [cited by applicant]