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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

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 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

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.

Find a Location

Who is running the clinical trial?

Crohn's and Colitis FoundationOTHER
43 Previous Clinical Trials
27,412 Total Patients Enrolled
University of CalgaryLead Sponsor
805 Previous Clinical Trials
883,990 Total Patients Enrolled
Maitreyi Raman, MDPrincipal InvestigatorUniversity of Calgary
4 Previous Clinical Trials
225 Total Patients Enrolled

Media Library

Intermittent Fasting Clinical Trial Eligibility Overview. Trial Name: NCT05230160 — N/A
Crohn's Disease Research Study Groups: Intervention Group, Standard Medical Care Group
Crohn's Disease Clinical Trial 2023: Intermittent Fasting Highlights & Side Effects. Trial Name: NCT05230160 — N/A
Intermittent Fasting 2023 Treatment Timeline for Medical Study. Trial Name: NCT05230160 — N/A
~4 spots leftby Dec 2024
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