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.

NCT05230160 | Unknown DMC

• 1 other identifier: REB21-1539
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (3)

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

  A measure of body fat based on height and weight

  Baseline and Week 12

• Fecal Calprotectin: Change is being assessed

  FCP is a test used to detect inflammation in the colon and is associated with disease

  Baseline and Week 12

• C Reactive Protien: Change is being assessed

  A protein the liver produces in the presence of inflammatory disease

  Baseline and Week 12

Secondary Outcomes (5)

• 24 hour ASA food recalls: Change is being assessed.

  Baseline and week 12

• Serum and fecal metabolomics: Change is being assessed

  Baseline and Week 12

• Serum markers: Change is being assessed

  Baseline and week 12

• Body Composition: Change is being assessed

  Baseline and week 12

• Fecal microbiome: Change is being assessed

  Baseline and Week 12

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Intermittent Fasting

Standard Medical Care Group

NO 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.

Interventions

Intermittent Fasting OTHER

Intermittent Fasting (IF) is a dietary intervention that involves periodic intervals of no or very limited energy intake. Fasting and feeding intervals vary and the practice of IF commonly consists of either a daily fast for 16 hours, a 24-hour fast on alternate days, or a fast two days per week on non-consecutive days. For the study, the IF group will be asked to fast for 16 consecutive hours, 6 days per week. This means they will have an 8-hour eating window (e.g., eat from 10 a.m. to 6 p.m.) each day. They will be asked to eat the same types of food and the same amounts as usual, but only during the 8-hour eating window.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 to ≤ 75 years of age;
• ileocolonic or colonic CD in clinical remission diagnosed through conventional definitions with a Harvey Bradshaw Index (HBI) \< 5 within 3 months of recruitment;
• presence of inflammation using an FCP ≥ 250 µg/g or a CRP ≥ 5 mg/L;
• 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
• presence of overweight or obesity with BMI \> 25 and a PG-SGA of class A.

You may not qualify if:

• upper gastrointestinal involvement CD, fistulizing disease;
• documented strictures based on sonographic findings or colonoscopy within the last year;
• \> 1 small bowel resection;
• colectomy;
• presence of an ostomy;
• antibiotic use in past 3-months;
• pregnancy;
• corticosteroids in the last 3 months.

Sponsors & Collaborators

• University of Calgary: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (1)

TRW building, Foothills, University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Maitreyi Raman, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maitreyi Raman, MD

CONTACT

403-592-5020; mkothand@ucalgary.ca

Lorian Taylor, PhD, RD

CONTACT

4039525154; lorian.taylor@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 8, 2022
• Study Start: March 1, 2022
• Primary Completion: December 20, 2024
• Study Completion: June 30, 2025
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)