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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 12

Awards & highlights

CD-Fast Trial 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.Check my eligibility

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.See study design

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.

CD-Fast Trial 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.

CD-Fast Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

24 hour ASA food recalls: Change is being assessed.

Body Composition: Change is being assessed

Fecal microbiome: Change is being assessed

+2 more

CD-Fast 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 / 2Eligibility criteria met

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Who is running the clinical trial?

Crohn's and Colitis FoundationOTHER

43 Previous Clinical Trials

28,083 Total Patients Enrolled

University of CalgaryLead Sponsor

791 Previous Clinical Trials

868,692 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities at present to participate in this scientific investigation?

"Clinicaltrials.gov indicates that this medical trial, initially posted on March 1st 2022 and last edited on January 27th 2022, is no longer looking for participants to join the study. Fortunately, there are currently 475 other trials actively recruiting patients."

Answered by AI

Would I be accepted as a participant in this clinical research?

"This medical trial is recruiting forty-two individuals with ileocolitis between 18 and 75 years of age. In order to be eligible, they must meet a set of criteria including: having an HBI score below 5 in the last 3 months; evidence of inflammation indicated by FCP ≥ 250 µg/g or CRP ≥ 5 mg/L; no changes to their medication regimen for at least three months; BMI > 25 and PG-SGA class A."

Answered by AI

Does this medical experiment have an age limit, and if so what is it?

"According to the study's parameters, those who are at least 18 years old and not older than 75 can participate in this trial."

Answered by AI

What aims has this clinical experiment established?

"This clinical trial seeks to measure Fecal Calprotectin and its related changes over Baseline and Week 12 as the primary outcome. As secondary outcomes, 24 hour ASA food recall alterations as well serum markers such as Leptin, Adiponectin, IL-6, Irisin, Zonulin, Ghrehlin GLP-1 and GLP-2 are being monitored. Also relevant is a Serum and fecal metabolomics assessment that provides an overview of the organism's current metabolic status."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Can Intermittent Fasting Induce Weight Loss and Improve Gut Health as Compared to Standard Medical Care in Patients With Obesity/High BMI and Crohn's Disease.

Maitreyi Raman 2022. "Can Intermittent Fasting Induce Weight Loss and Improve Gut Health as Compared to Standard Medical Care in Patients With Obesity/High BMI and Crohn's Disease.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05230160.

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