Fasting Mimicking Diet for Ulcerative Colitis

Overseen By Touran Fardeen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Anti-diabetic drugs

Disqualifiers: Pregnancy, Nut allergy, Low BMI, others

Compensation: Varies

Number of Visits: 4

Duration: 3 months

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special diet that mimics fasting, known as the Fasting Mimicking Diet (FMD), can reduce inflammation and improve life quality for individuals with mild to moderate Ulcerative Colitis (UC). Participants will follow a five-day reduced-calorie diet, repeated over three cycles, to assess its impact on UC symptoms. The trial will compare these participants with a group on a regular diet to measure differences. Individuals who have experienced UC symptoms for some time and can safely adhere to the diet plan may be suitable candidates for the trial. As an unphased trial, this study provides a unique opportunity to explore innovative dietary approaches for managing UC symptoms.

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 prior data suggests that the Fasting Mimicking Diet is safe for patients with Ulcerative Colitis?

Research suggests that a fasting mimicking diet (FMD) might be safe for people to try. In earlier studies, researchers tested FMD on mice and observed positive effects, such as reduced gut inflammation and improved gut tissue repair. This is encouraging for conditions like inflammatory bowel disease, including ulcerative colitis.

Although specific data on humans remains limited, the FDA considers the diet's ingredients "Generally Recognized as Safe," meaning they are widely accepted as safe to eat. The diet aims to provide fasting benefits without requiring complete cessation of eating, potentially making it easier to follow.

In summary, while more research is needed specifically in humans, current evidence suggests that FMD is generally well-tolerated and could be safe for those interested in trying it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Fasting Mimicking Diet (FMD) is unique because it offers a dietary approach to managing ulcerative colitis, rather than relying on medications like mesalamine or corticosteroids. This diet mimics fasting by significantly reducing calorie intake for specific periods, which may help reduce inflammation and promote gut healing without the side effects often associated with pharmaceutical treatments. Researchers are excited about the FMD because it leverages the body's natural processes to potentially improve symptoms and overall gut health, offering a novel, non-drug alternative for people with ulcerative colitis.

What evidence suggests that the Fasting Mimicking Diet might be an effective treatment for Ulcerative Colitis?

Research has shown that the fasting mimicking diet (FMD), which participants in this trial may receive, might help lower inflammation in people with mild to moderate Ulcerative Colitis (UC). In animal studies, FMD reduced intestinal swelling and promoted healing. This diet imitates the effects of fasting, potentially reducing inflammation without requiring complete cessation of eating. Additionally, FMD has been linked to an increase in intestinal stem cells, aiding in gut repair. While more research is needed in humans, these early findings suggest that FMD could ease symptoms and improve gut health in people with UC. ^{1 2 3 4 6}

Who Is on the Research Team?

Sidhartha R Sinha, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Patients on a caloric restricted diet will also be excluded.

Individuals diagnosed with a serious medical condition as defined by the patient's physician, unless approved in writing by a physician

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Fasting Mimicking Diet
• Regular Diet

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6528490/

Fasting-Mimicking Diet Modulates Microbiota and Promotes ... Overall, these data suggest that FMD cycles reversed several symptoms and pathology in a mouse model for IBD. In contrast, water-only fasting does not promote ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03615690

The Influence of a Fasting Mimicking Diet on Ulcerative ... The purpose of this study is to see how a diet that mimics fasting effects inflammation in patients with mild to moderate Ulcerative Colitis (UC).

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955286321002059

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

4. gero.usc.edu gero.usc.edu/2019/03/05/fasting-mimicking-diet-holds-promise-for-treating-people-with-inflammatory-bowel-disease-usc-study-finds/

Fasting-mimicking diet holds promise for treating people ... Results showed that fasting-mimicking diet caused a reduction in intestinal inflammation and an increase in intestinal stem cells in part by ...

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/340579

The Influence of a Fasting Mimicking Diet on Ulcerative ... The purpose of this study is to see how a diet that mimics fasting effects inflammation in patients with mild to moderate Ulcerative Colitis ...

6. nature.com nature.com/articles/s41522-024-00520-w

Fasting-mimicking diet remodels gut microbiota and ... These FMD cycles effectively suppressed colorectal cancer growth, reduced cell proliferation and angiogenesis, increased tumor-infiltration ...