NCT04147585Completed
Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease
Source: ClinicalTrials.gov · Last updated 17 Apr 2025
Brief summary (registry, in English)
The purpose of this study is to see how an Intermittent Calorie Reduced Diet (IRCD) that mimics fasting (also known as a fasting mimicking diet, FMD) effects inflammation in patients with mild to moderate Crohn's disease (CD). 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 CD are very limited. Diets that mimick fasting 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 five-day periods of the IRCD, and may provide rationale for its use to treat CD.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 86 (actual)
- First submitted
- 25 Oct 2019
- Start date
- 18 Dec 2019
- Primary completion date
- 12 Mar 2024
- Lead sponsor
- Stanford University
- Diseases
- Crohn's disease
- NCT number
- NCT04147585
What you commit to
- Study type: Interventional
- Participants enrolled: 86
- From 18 Dec 2019 to the primary completion date, 12 Mar 2024
- 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,total colectomy, proctocolectomy, ileoanal pouch will be excluded (not excluded are patients with resection of terminal ileum, resection of short strictures of the small intestine, hemicolectomy).
Other illness
- Individuals allergic to nuts
- Individuals diagnosed with a serious medical condition (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, nursing or expect to be pregnant
- Individuals with a body mass index (BMI) lower than 18
- Individuals with dietary needs incompatible with the IRCD meal plan
- Patients on a calorie restricted diet will also be excluded
Who the study is looking for
- Mild to moderate Crohn's disease (CDAI score 151-450)
- Between the ages of 18-70 (inclusive)
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
Related publications
- A fasting-mimicking diet in patients with mild-to-moderate Crohn's disease: a randomized controlled trial.Nat Med · 2026 · PMID 41530382
This page is information, not medical advice. Discuss any trial with your doctor.