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NCT03615690Recruiting

The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

Source: ClinicalTrials.gov · Last updated 27 Feb 2026

Brief summary (registry, in English)

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). The diet may allow users to receive the benefits of fasting while also being able to enjoy food (the ingredients of which are GRAS (generally recognized as safe) by the Food and Drug Administration (FDA). Research on dietary interventions and UC are very limited. Fasting mimicking diets (FMD) have been studied with support of the National Institute of Health and published in leading journals. This research investigates whether markers of inflammation decrease and/or quality of life increases after three cycles of a five-day period of the fasting mimicking diet, and may provide rationale for its use to treat UC.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
75 (estimated)
First submitted
3 Jul 2018
Start date
15 Dec 2020
Primary completion date
Dec 2027
Lead sponsor
Stanford University
NCT number
NCT03615690

What you commit to

  • Study type: Interventional
  • Planned participants: 75
  • From 15 Dec 2020 to the primary completion date, Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Individuals who are taking medication which may not be safely consumed with a calorie restricted diet
  • 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.

Other illness

  • Individuals allergic to nuts
  • 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 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 a history of syncope

Lab values

  • Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \< 40%)
  • Individuals with liver or kidney disorders that may be affected by very low glucose and protein content of the diet.

Other

  • Women who are pregnant or nursing or expect to be pregnant
  • Individuals with a body mass index (BMI) lower than 18
  • Individuals with dietary needs incompatible with the FMD meal plan
  • Patients on a caloric restricted diet will also be excluded.

Who the study is looking for

  • 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)

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Stanford University
Coordinator of this site? Confirm its status
Palo AltoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.