Fasting Mimicking Diet for Ulcerative Colitis
Recruiting in Palo Alto (17 mi)
Overseen bySidhartha R Sinha, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Must not be taking: Anti-diabetic drugs
Disqualifiers: Pregnancy, Nut allergy, Low BMI, others
Trial Summary
What is the purpose of this trial?This trial is testing a special diet that mimics fasting in people with mild to moderate Ulcerative Colitis. The diet allows people to eat certain safe foods while getting the benefits of fasting. Researchers want to see if this diet can reduce inflammation and improve quality of life for these patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it excludes people taking medications that may not be safe with a calorie-restricted diet. It's best to discuss with your doctor if your medications fall into this category.
What data supports the effectiveness of the Fasting Mimicking Diet treatment for Ulcerative Colitis?
Research on mice has shown that a fasting-mimicking diet can reduce inflammation and help repair the intestines in inflammatory bowel disease, which is similar to ulcerative colitis. Additionally, a case study of a patient with ulcerative colitis found that intermittent fasting reduced inflammation markers and improved symptoms.
12345Is the Fasting Mimicking Diet safe for humans?
Research suggests that the Fasting Mimicking Diet (FMD) may be safe for humans, as it has been shown to reduce markers of inflammation in a clinical trial. However, more large-scale studies are needed to confirm its safety and effects in humans.
14678How does the Fasting Mimicking Diet treatment differ from other treatments for ulcerative colitis?
The Fasting Mimicking Diet (FMD) is unique because it involves cycles of reduced calorie intake that mimic fasting, which can reduce inflammation and promote intestinal repair, unlike traditional treatments that may not focus on dietary interventions. This approach has shown promise in reducing inflammation markers and improving gut health in both animal models and early human trials.
12348Eligibility Criteria
Adults aged 18-70 with mild to moderate Ulcerative Colitis can join this study. They must not be underweight, pregnant, or nursing and should have no history of significant heart disease, liver or kidney disorders, severe illness, recent weakening medical procedures, or specific dietary restrictions including nut allergies.Inclusion Criteria
My Ulcerative Colitis is mild to moderate.
I am between 18 and 70 years old.
Exclusion Criteria
Patients on a caloric restricted diet will also be excluded.
You have severe heart disease or advanced-stage cancer that may be life-threatening, as determined by your doctor. You cannot participate in the study unless approved by a doctor.
Individuals diagnosed with a serious medical condition as defined by the patient's physician, unless approved in writing by a physician
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo three cycles of a 5-day fasting mimicking diet, administered once a month, followed by a regular diet for the rest of the month
3 months
3 visits (in-person) for each cycle
Follow-up
Participants are monitored for changes in inflammatory markers and quality of life after completing the treatment cycles
3 months
1 visit (in-person) and assessments within 6 days after completing Cycle 3
Participant Groups
The trial is testing a Fasting Mimicking Diet (FMD) against a regular diet in people with Ulcerative Colitis. Participants will undergo three cycles of a five-day FMD to see if it reduces inflammation and improves quality of life compared to those on their usual diet.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fasting Mimicking DietExperimental Treatment1 Intervention
Three cycles of a 5-day reduced calorie diet
Group II: Regular Diet Control ArmPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityPalo Alto, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
References
Therapeutic Implications of Diet in Inflammatory Bowel Disease and Related Immune-Mediated Inflammatory Diseases. [2022]Despite being a focal issue to patients, the effect of diet on adult inflammatory bowel disease (IBD) remains underexplored with limited guidance. While promising clinical trials are currently underway, there is a need for further evidence-based recommendations. As such, we summarize the current evidence on various diets used in the treatment of IBD and also explore the potential applications of dietary data from related immune-mediated inflammatory diseases (IMIDs), such as rheumatoid arthritis and psoriasis, to provide additional information to inform IBD providers. To date, there have been multiple diets investigated as adjunctive therapy in IBD, but many associated studies are small, non-randomized, and not controlled. Mediterranean, vegetarian/vegan, and reduced-calorie/fasting diets have been studied and have shown some positive results in other IMIDs, which may suggest potential applicability to those with IBD, but larger, well-designed clinical trials are needed for further guidance. Gluten-free and low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP)diets do not appear to have an impact on IBD disease activity, but low FODMAP may potentially be helpful for those with concurrent functional gastrointestinal symptoms. Specific carbohydrate diets have been mainly assessed in children but show some potential in small adult studies.
Fecal microbiota transplantation combined with prebiotics ameliorates ulcerative colitis in mice. [2023]Aim: To investigate the effect of treatment with fecal microbiota transplantation (FMT) and galacto- and fructo-oligosaccharides on ulcerative colitis (UC) in mice. Materials & methods: A total of 90 mice, divided into nine groups, were administered FMT or prebiotics or combined treatment. The disease activity index scores, gut microbiota and inflammation factors were evaluated. Results: The treatment using FMT combined with galacto- and fructo-oligosaccharides in a 9:1 ratio significantly reduced intestinal barrier damage and alleviated symptoms of UC. Lactobacillus and Bifidobacterium and short-chain fatty acids were significantly increased after the combined treatment. Conclusion: The results demonstrate that FMT with prebiotics is a new method for UC treatment.
Intermittent Fasting and Reduction of Inflammatory Response in a Patient with Ulcerative Colitis. [2023]Ulcerative colitis is an inflammatory disease that affects the colon, generating a crisis period associated with diarrhea and ulcerations. Stress plays a pivotal role in modulating the inflammatory response and aggravating progression. Different studies have shown that fasting reduces inflammation markers, and intermittent fasting decreases inflammatory markers such as IL-2, IL-6, and RCP. Goal: To evaluate the impact of intermittent fasting on a patient diagnosed with ulcerative colitis. A female patient underwent intermittent fasting (10/14) for eight weeks. Clinical tests were performed for blood count, RCP, biochemical profile, glycemia, and T4/TSH levels. Fecal calprotectin was determined. Clinical exams were assessed before and after intermittent fasting. Inflammation markers, such as CRP and calprotectin, were significantly reduced after eight weeks of intermittent fasting. The patient reported feeling better and was seizure-free during the following months when she continued fasting intermittently. Intermittent fasting allowed for a reduction in inflammation markers.
Intermittent administration of a fasting-mimicking diet reduces intestinal inflammation and promotes repair to ameliorate inflammatory bowel disease in mice. [2021]Recent studies have revealed that calorie restriction is able to modulate immune system and aid in intervention of immune disorders. Inflammatory bowel disease (IBD) is an immune disease in the intestine caused by interplay between genetic susceptibility and environmental factors such as diets. Here we analyzed the therapeutic effect of intermittent calorie restriction with a fasting-mimicking diet (FMD) on dextran sodium sulfate (DSS)-induced chronic IBD model in mice. Two cycles of FMD was administered after IBD symptoms occurred in the mice. FMD administration significantly reduced the score of disease activity index. FMD reversed DSS-mediated shortening of colon length, infiltration of lymphocytes in the crypt of colon, and accumulation of CD4+ cells in the colon and small intestine. The expression of an inflammation marker NLRP3 was also reduced by FMD administration. The percentage of CD4+ T cells in both peripheral blood and spleen was also reduced by FMD. In addition, FMD application reversed DSS-mediated reduction in intestinal stem cell marker Lgr5, while the cell proliferation markers Ki67 and PCNA were increased by FMD. Taken together, these results indicate that in the mouse model of IBD, application of the FMD can effectively ameliorate the symptoms and pathogenesis of IBD through reducing the inflammation of intestine and promoting the regeneration and repair of the damaged intestinal epithelium.
Dietary adherence to the Mediterranean diet pattern in a randomized clinical trial of patients with quiescent ulcerative colitis. [2023]The Mediterranean diet pattern (MDP) is believed to improve health and promote balanced inflammation and metabolism. While unknown, compelling evidence suggests that MDP could benefit patients with inflammatory bowel disease (IBD). We aimed to evaluate the level of diet adherence, diet quality, and nutritional adequacy of the MDP in patients with Ulcerative Colitis (UC).
A randomized, 6-wk trial of a low FODMAP diet in patients with inflammatory bowel disease. [2020]The aim of this study was to assess the safety and efficacy of a low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet (LFD) in patients with inflammatory bowel disease (IBD).
Dietary Guidance From the International Organization for the Study of Inflammatory Bowel Diseases. [2021]Recent evidence points to a plausible role of diet and the microbiome in the pathogenesis of both Crohn's disease (CD) and Ulcerative Colitis (UC). Dietary therapies based on exclusion of table foods and replacement with nutritional formulas and/or a combination of nutritional formulas and specific table foods may induce remission in CD. In UC, specific dietary components have also been associated with flare of disease. While evidence of varying quality has identified potential harmful or beneficial dietary components, physicians and patients at the present time do not have guidance as to which foods are safe, may be protective or deleterious for these diseases. The current document has been compiled by the nutrition cluster of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) based on the best current evidence to provide expert opinion regarding specific dietary components, food groups and food additives that may be prudent to increase or decrease in the diet of patients with inflammatory bowel diseases to control and prevent relapse of inflammatory bowel diseases.
Fasting-Mimicking Diet Modulates Microbiota and Promotes Intestinal Regeneration to Reduce Inflammatory Bowel Disease Pathology. [2020]Dietary interventions are potentially effective therapies for inflammatory bowel diseases (IBDs). We tested the effect of 4-day fasting-mimicking diet (FMD) cycles on a chronic dextran sodium sulfate (DSS)-induced murine model resulting in symptoms and pathology associated with IBD. These FMD cycles reduced intestinal inflammation, increased stem cell number, stimulated protective gut microbiota, and reversed intestinal pathology caused by DSS, whereas water-only fasting increased regenerative and reduced inflammatory markers without reversing pathology. Transplants of Lactobacillus or fecal microbiota from DSS- and FMD-treated mice reversed DSS-induced colon shortening, reduced inflammation, and increased colonic stem cells. In a clinical trial, three FMD cycles reduced markers associated with systemic inflammation. The effect of FMD cycles on microbiota composition, immune cell profile, intestinal stem cell levels and the reversal of pathology associated with IBD in mice, and the anti-inflammatory effects demonstrated in a clinical trial show promise for FMD cycles to ameliorate IBD-associated inflammation in humans.