Effects of a fasting mimicking diet on ulcerative colitis
The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
This study is testing whether a fasting mimicking diet can help reduce inflammation and improve quality of life for people with mild to moderate ulcerative colitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT03615690 on ClinicalTrials.gov |
What this trial studies
This study investigates how a fasting mimicking diet (FMD) influences inflammation in patients with mild to moderate ulcerative colitis. Participants will follow a diet that allows them to experience the benefits of fasting while consuming food deemed safe by the FDA. The research aims to assess changes in inflammation markers and quality of life after three cycles of a five-day FMD. This approach is novel as dietary interventions for ulcerative colitis have been limited in previous research.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with mild to moderate ulcerative colitis as indicated by a partial Mayo score between 2 and 7.
Not a fit: Patients who are pregnant, nursing, or have serious medical conditions that could complicate dietary changes may not benefit from this study.
Why it matters
Potential benefit: If successful, this diet could provide a new dietary management strategy for patients with ulcerative colitis, potentially reducing inflammation and improving quality of life.
How similar studies have performed: While dietary interventions for ulcerative colitis are limited, fasting mimicking diets have shown promise in other studies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mild to moderate Ulcerative Colitis on the partial Mayo Score out of 9 (score between 2 to 7) * Age of 18-70 at start of study (inclusive) Exclusion Criteria: * Women who are pregnant or nursing or expect to be pregnant * Individuals allergic to nuts * Individuals with a body mass index (BMI) lower than 18 * Individuals diagnosed with a serious medical condition as defined by the patient's physician, unless approved in writing by a physician * Individuals who have been severely weakened by a disease or medical procedure, * Individuals who are taking medication which may not be safely consumed with a calorie restricted diet * Individuals with diabetes who are taking anti-diabetic drugs associated with risk of hypoglycemia * Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician * Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \< 40%) * Individuals with a history of syncope * Individuals with dietary needs incompatible with the FMD meal plan * Individuals with liver or kidney disorders that may be affected by very low glucose and protein content of the diet. * Patients on a caloric restricted diet will also be excluded. * Patients with relevant prior gastrointestinal surgery and consequences such as short bowel syndrome, ostomy of small or large intestine, hemi- or total colectomy, proctocolectomy, ileoanal pouch will be excluded.
Where this trial is running
Palo Alto, California
- Stanford University — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Sidhartha R Sinha, MD — Stanford University
- Study coordinator: Touran Fardeen
- Email: tfardeen@stanford.edu
- Phone: 6507367311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.