Intermittent Fasting for Weight Loss in Crohn's Disease
(CD-Fast Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMaitreyi Raman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Calgary

No Placebo Group

Trial Summary

What is the purpose of this trial?Diet is a determinant of gut microbial diversity and composition and is recognized as a potential environmental trigger for IBD; for example, high-fat diets are associated with increased risk of CD in pre-clinical models, with effects mediated through dysbiosis and altered gut permeability. Diet is also a potential non-pharmacological therapy for weight loss and for reducing the occurrence of disease flares and the reliance on dose escalation of biologic agents. Indeed, there is accumulating evidence for the role of diet in the treatment of CD, and diet-induced improvement of microbial dysbiosis is associated with induction of remission in pediatric patients with active CD. Intermittent Fasting (IF) is a dietary intervention that involves periodic intervals of no or very limited energy intake. We want to determine the efficacy and feasibility of a 12-week IF(Intermittent Fasting) intervention to induce weight loss (by 1 BMI unit reduction), decrease biomarker inflammation and increase microbial functional diversity compared to standard medical management (SM) in a pilot study of individuals with overweight or obesity and CD in clinical remission with elevated biomarkers of inflammation, indicated by fecal calprotectin (FCP) \> 250 µg/g or C-reactive protein (CRP) \> 5 mg/L).

Eligibility Criteria

This trial is for adults aged 18-75 with Crohn's Disease in remission and a BMI over 25, indicating overweight or obesity. Participants must have inflammation shown by specific blood or stool tests and be on stable medication doses without recent steroid use, surgery, or antibiotics.

Inclusion Criteria

My medication for inflammation or immune response has been stable for 3 months.

You are considered overweight or obese with a body mass index (BMI) greater than 25 and have a good nutritional status according to a special assessment.

presence of inflammation using an FCP ≥ 250 µg/g or a CRP ≥ 5 mg/L

+2 more

Exclusion Criteria

I have had more than one surgery to remove parts of my small intestine.

I have had a test in the last year showing narrowing in my intestines.

My Crohn's disease affects my upper GI tract and has caused fistulas.

+5 more

Participant Groups

The study examines if Intermittent Fasting (IF) can help reduce weight by at least one BMI unit and improve gut health compared to standard medical care. Over 12 weeks, the effects of IF on weight loss, inflammation markers, and microbial diversity in the gut will be measured.

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

The IF group will fast for 16 consecutive hours on 6 days per week with an 8-hour eating window (e.g., eat from 10 a.m. to 6 p.m.). The IF group will consume their habitual diet in terms of food choices and energy intake, but only during the 8-hour and full-day non-fasting periods. An RD will meet virtually with participants in the IF group at baseline to teach them the fasting protocol and how to manage energy intake and hunger, as well as to reinforce the requirement to not change habitual dietary practices. The research coordinator will call patients every two weeks to assess for changes in medications, compliance with the fasting protocol, and symptoms (assessed monthly) using the modified HBI.

Group II: Standard Medical Care GroupActive Control1 Intervention

The control group will continue with their habitual dietary pattern. The research coordinator will call patients at baseline and every two weeks to assess for changes in medications and symptoms (assessed monthly) using the modified HBI.