Intermittent Fasting for Crohn's Disease

Overseen By Touran Fardeen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Anti-diabetic drugs

Disqualifiers: Pregnancy, Nut allergy, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

86 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Sidhartha R Sinha, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

Three cycles of a 5-day Intermittent Reduced Calorie Diet

Group II: Control Arm Active Control 1 Intervention

Regular Diet

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+