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The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
NCT03615690 · Stanford University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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 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 target: 75 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2020-12-15
Estimated completion: 2028-12
Last updated: 2026-02-27
Interventions
Other: Fasting Mimicking DietOther: Regular Diet
Primary outcomes
- • Clinical response as per partial Mayo score (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.)
Sponsor
Stanford University · other
Contacts & investigators
ContactTouran Fardeen · contact · tfardeen@stanford.edu · 6507367311
InvestigatorSidhartha R Sinha, MD · principal_investigator, Stanford University
All locations (1)
Stanford UniversityRecruiting
Palo Alto, California, United States