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

N/A

Waitlist Available

Led By Maitreyi Raman, MD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

stable dosing of biologic agents and/or immunomodulators and/or oral or rectal 5-ASA, and no changes to medical management (including corticosteroid exposure) for at least 3 months prior to recruitment

≥ 18 to ≤ 75 years of age

Must not have

> 1 small bowel resection

documented strictures based on sonographic findings or colonoscopy within the last year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a 12-week IF intervention can help people with overweight or obesity and CD in clinical remission with elevated biomarkers of inflammation lose weight, decrease inflammation, and increase microbial functional diversity compared to standard medical management.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Intermittent Fasting may cause initial discomfort like hunger pangs, headaches, weakness or irritability due to changes in eating patterns but typically subsides as the body adapts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I have had surgery to remove part or all of my colon.

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I have not taken antibiotics in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BMI-A decrease in BMI of at least 1 BMI unit over the course of the intervention: Change is being assessed

C Reactive Protien: Change is being assessed

Fecal Calprotectin: Change is being assessed

Secondary study objectives

24 hour ASA food recalls: Change is being assessed.

Body Composition: Change is being assessed

Fecal microbiome: Change is being assessed

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 7Eligibility criteria met