The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

Last updated: April 14, 2025
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bowel Dysfunction

Crohn's Disease (Pediatric)

Inflammatory Bowel Disease

Treatment

Regular Diet

Fasting Mimicking Diet

Clinical Study ID

NCT03615690
IRB 47075
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Mild to moderate Ulcerative Colitis on the partial Mayo Score out of 9 (scorebetween 2 to 7)

  • Age of 18-70 at start of study (inclusive)

Exclusion

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'sphysician, 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 acalorie restricted diet

  • Individuals with diabetes who are taking anti-diabetic drugs associated with risk ofhypoglycemia

  • Individuals with more than mild-moderate cardiovascular disease or life-threateningcancer (as determined by patient's physician) unless approved by a physician

  • Individuals with history of severe cardiac disease (particularly uncompensatedcongestive 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 glucoseand 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 shortbowel syndrome, ostomy of small or large intestine, hemi- or total colectomy,proctocolectomy, ileoanal pouch will be excluded.

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Regular Diet
Phase:
Study Start date:
December 15, 2020
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Stanford University

    Palo Alto, California 94305
    United States

    Active - Recruiting

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