Effects of a fasting mimicking diet on ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.