86 Participants Needed

Intermittent Fasting for Crohn's Disease

TF
Overseen ByTouran Fardeen
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

SR

Sidhartha R Sinha, MD

Principal Investigator

Stanford University

Eligibility Criteria

Adults aged 18-70 with mild to moderate Crohn's disease can join this trial. It's not for those allergic to nuts, severely weakened by illness or medical procedures, with severe heart issues, pregnant/nursing women, or anyone on a calorie-restricted diet. People who've had certain gastrointestinal surgeries or have serious conditions like diabetes at risk of hypoglycemia are also excluded.

Inclusion Criteria

My Crohn's disease is in the mild to moderate stage.

Exclusion Criteria

I do not have severe heart disease, such as bad heart failure or a weak heart pump.
I am severely weakened by a disease or medical procedure.
I am not pregnant, nursing, or planning to become pregnant.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo three cycles of a 5-day Intermittent Reduced Calorie Diet (IRCD) administered once a month, followed by a regular diet for the rest of the month

3 months

Follow-up

Participants are monitored for changes in quality of life, clinical response, and inflammatory markers after the treatment phase

3 months

Treatment Details

Interventions

  • Intermittent Reduced Calorie Diet (IRCD)
Trial Overview The study tests an Intermittent Reduced Calorie Diet (IRCD) that mimics fasting and is safe according to the FDA. The goal is to see if IRCD reduces inflammation and improves life quality in Crohn's disease patients over five-day periods.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Three cycles of a 5-day Intermittent Reduced Calorie Diet
Group II: Control ArmActive Control1 Intervention
Regular Diet

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+
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