Fasting Mimicking Diet for Ulcerative Colitis

Overseen by Sidhartha 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. ^{1 2 3 4 5}

Is 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. ^{1 4 6 7 8}

How 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. ^{1 2 3 4 8}

Research Team

Sidhartha R Sinha, MD

Principal Investigator

Stanford University

Eligibility 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

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

Treatment Details

Interventions

• Fasting Mimicking Diet (Other)
• Regular Diet (Other)

Trial Overview 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.

Participant Groups

Group I: Fasting Mimicking Diet Experimental Treatment 1 Intervention

Three cycles of a 5-day reduced calorie diet

Group II: Regular Diet Control Arm Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

Findings from Research

Current evidence on the impact of diet on adult inflammatory bowel disease (IBD) is limited, with many studies being small and not well-controlled, highlighting the need for larger, more rigorous clinical trials.

Diets such as Mediterranean, vegetarian/vegan, and reduced-calorie/fasting have shown promise in related immune-mediated inflammatory diseases and may be beneficial for IBD, while gluten-free and low FODMAP diets do not significantly affect IBD activity but may help with related gastrointestinal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Implications of Diet in Inflammatory Bowel Disease and Related Immune-Mediated Inflammatory Diseases. Jiang, Y., Jarr, K., Layton, C., et al.[2022]

In a study involving 90 mice, treatment with fecal microbiota transplantation (FMT) combined with galacto- and fructo-oligosaccharides significantly reduced intestinal damage and symptoms of ulcerative colitis (UC).

The combined treatment notably increased beneficial gut bacteria like Lactobacillus and Bifidobacterium, as well as short-chain fatty acids, suggesting a positive impact on gut health and inflammation in UC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation combined with prebiotics ameliorates ulcerative colitis in mice. Qian, X., Jiang, H., Wu, Y., et al.[2023]

Intermittent fasting (10/14 hours) over eight weeks significantly reduced inflammation markers, such as CRP and fecal calprotectin, in a female patient with ulcerative colitis.

The patient reported improved well-being and remained seizure-free during the months following the intermittent fasting regimen, suggesting potential benefits beyond inflammation reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Fasting and Reduction of Inflammatory Response in a Patient with Ulcerative Colitis. Roco-Videla, Á., Villota-Arcos, C., Pino-Astorga, C., et al.[2023]

Intermittent calorie restriction using a fasting-mimicking diet (FMD) significantly improved symptoms of inflammatory bowel disease (IBD) in a mouse model, reducing disease activity and inflammation markers.

FMD not only decreased inflammation in the intestines but also promoted the regeneration of intestinal cells, suggesting it could be a beneficial therapeutic approach for IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent administration of a fasting-mimicking diet reduces intestinal inflammation and promotes repair to ameliorate inflammatory bowel disease in mice. Song, S., Bai, M., Ling, Z., et al.[2021]

In a 12-week study with 32 adults having quiescent Ulcerative Colitis, those following the Mediterranean diet pattern (MDP) showed significantly higher adherence and improved diet quality compared to those on the Canadian Habitual Diet.

Participants on the MDP experienced reductions in certain bowel symptoms, such as gas and tenesmus, without any reported adverse events, although nutritional inadequacies in key vitamins and minerals were noted, highlighting the need for tailored dietary education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary adherence to the Mediterranean diet pattern in a randomized clinical trial of patients with quiescent ulcerative colitis. Haskey, N., Shim, RCK., Davidson-Hunt, A., et al.[2023]

A 6-week low FODMAP diet (LFD) was found to be safe for patients with inflammatory bowel disease (IBD) and led to significant improvements in disease activity, as indicated by a decrease in the Harvey-Bradshaw index.

The LFD also resulted in a notable reduction in fecal calprotectin levels, a marker of inflammation, and showed a slight improvement in quality of life for patients, suggesting its potential benefits even in those with mild disease activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, 6-wk trial of a low FODMAP diet in patients with inflammatory bowel disease. Bodini, G., Zanella, C., Crespi, M., et al.[2020]

Diet and the microbiome may play a significant role in the development and management of Crohn's disease (CD) and Ulcerative Colitis (UC), with specific dietary therapies showing potential to induce remission in CD.

The International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) has compiled expert opinions to guide patients and physicians on dietary components that may help control or prevent relapses in inflammatory bowel diseases, addressing the current lack of clear dietary guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Guidance From the International Organization for the Study of Inflammatory Bowel Diseases. Levine, A., Rhodes, JM., Lindsay, JO., et al.[2021]

A 4-day fasting-mimicking diet (FMD) significantly reduced intestinal inflammation and reversed pathology in a mouse model of inflammatory bowel disease (IBD), while also increasing beneficial gut microbiota and stem cell numbers.

In a clinical trial, FMD cycles were effective in reducing systemic inflammation markers, suggesting that FMD may be a promising dietary intervention for managing IBD in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting-Mimicking Diet Modulates Microbiota and Promotes Intestinal Regeneration to Reduce Inflammatory Bowel Disease Pathology. Rangan, P., Choi, I., Wei, M., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic Implications of Diet in Inflammatory Bowel Disease and Related Immune-Mediated Inflammatory Diseases. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation combined with prebiotics ameliorates ulcerative colitis in mice. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Intermittent Fasting and Reduction of Inflammatory Response in a Patient with Ulcerative Colitis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Intermittent administration of a fasting-mimicking diet reduces intestinal inflammation and promotes repair to ameliorate inflammatory bowel disease in mice. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary adherence to the Mediterranean diet pattern in a randomized clinical trial of patients with quiescent ulcerative colitis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A randomized, 6-wk trial of a low FODMAP diet in patients with inflammatory bowel disease. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Dietary Guidance From the International Organization for the Study of Inflammatory Bowel Diseases. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Fasting-Mimicking Diet Modulates Microbiota and Promotes Intestinal Regeneration to Reduce Inflammatory Bowel Disease Pathology. [2020]