Recruiting

Fasting Mimicking Diet

Sponsor:

Stanford University

Code:

NCT03615690

Conditions

Inflammatory Bowel Disease

Diet Modification

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Fasting Mimicking Diet

Regular Diet

Study Details

Brief summary:

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.

Conditions

Inflammatory Bowel Disease

Diet Modification

Ulcerative Colitis

Study ID

NCT03615690

Start date

Dec 15, 2020

Status verified date

Feb, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fasting Mimicking Diet

Three cycles of a 5-day reduced calorie diet

placebo comparator: Regular Diet Control Arm

Interventions

Fasting Mimicking Diet

5 day reduced calorie diet

Regular Diet

Regular Diet

Primary outcome measure

  • Clinical response as per partial Mayo score [ Time Frame: Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. ]

Central Contacts and Locations

Central contacts

Touran Fardeen

6507367311tfardeen@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94305

Contacts

Touran Fardeen

tfardeen@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • ulcerative colitis
  • IBD
  • diet
  • fasting
  • fasting mimicking diet
  • UC
  • intermittent fasting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-02-27.