The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
Not applicable · Testing Fasting Mimicking Diet and Regular Diet · 1 site · Stanford University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fasting Mimicking Diet and Regular Diet as a possible treatment. Condition(s) listed: Inflammatory Bowel Disease, Diet Modification and Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- 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)
There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 75 participants are expected to take part.
- Start date: 2020-12-15.
- Main results expected around 2027-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- 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…)
In the researchers’ words
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).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease; Diet Modification; Ulcerative Colitis |
| Lead sponsor | Stanford University |
| Enrollment | 75 (estimated) |
| Start date | 2020-12-15 |
| Primary completion (est.) | 2027-12 |
| First posted | 2018-08-06 |
| Last updated | 2026-02-27 |
| Official title | The Influence of a Fasting Mimicking Diet on Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT03615690 |
Interventions
- Fasting Mimicking Diet (Other)
5 day reduced calorie diet - Regular Diet (Other)
Regular Diet
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University | Palo Alto, California | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.