The Impact of Time Restricted Feeding in Crohn's Disease

Study Overview
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Brief Summary
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Time-restricted feeding (TRF) is a dietary regimen involving the consumption of food and liquids within a defined time window with or without additional restriction on dietary composition. TRF has been associated with improvements in inflammation, host metabolism, autophagy, gut microbial composition, and gut permeability. Crohn's disease is an inflammatory bowel disease of unknown etiology that likely results from a combination of genetic and environmental factors. This proposed study will test the hypothesis that a time-restricted feeding regimen will improve clinical outcomes and favorably influence the gut microbiome in patients with active Crohn's disease. If time-restricted fasting proves beneficial to this patient population then it will pave the way for larger, prospective studies and clinical trials.

Official Title
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The Impact of Time Restricted Feeding in Crohn's Disease

Conditions
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Crohn's Disease (CD)

Intervention / Treatment
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* Other: Time Restricted Feeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects has active Crohn's disease of the ileum and/or colon. The diagnosis should be confirmed by endoscopic or radiological evidence. Active inflammation on colonoscopy performed as evidenced by an SES-CD ≥ 6 (or ≥ 4 for isolated ileal disease) OR C-Reactive protein ≥ 1.0 mg/L OR fecal calprotectin ≥ 250 μg/g. Any or all of these results must be from within 180 days of study entrance. Subject should have BMI of >18.5 and <40 Exclusion Criteria: Subjects who decline to provide informed consent Subject with a history of an eating disorder, major gastrointestinal surgery within the past 3 months. Subject with a history of antibiotic use within 4 weeks. Subject with a history of bowel obstruction within the past 12 months Subject with a history of diabetes requiring medication Subject who is currently pregnant or breastfeeding will be excluded Subjects with current antibiotic use. In order to participate, subjects will be required to have a 2-week wash-out period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time Restricted Feeding<br>Subjects will be required to fast for 16 consecutive hours daily for 4 weeks. The registered dietitian will provide subjects counseling on the intermittent fasting regimen. | Other: Time Restricted Feeding<br>* The counseling on the regimen will involve instructing the subjects on study compliance and fasting times. Subjects will be instructed to choose an eight-hour eating window (e.g., 11:00am - 7:00pm) during which the patient will be able to eat his/her normal diet. During the 16-hour fasting window (e.g., 7:00pm - 11:00am), the participant will be able to drink regular water and black coffee.<br>* Other names: Intermittent Fasting;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient reported outcomes as measured by Patient Recorded Outcome 2 (PRO2) scores. | This will be measured to assess clinical response as determined by a reduction of either 8 or more points or a total PRO2 score of less than or equal to 8 points. The PRO2 score scale ranges from a score of 0 as the minimum and has no maximum limit. A score below 8 is considered remission; a score less than 14 is considered mild; and a score greater than 34 is considered severe. | Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet | 
| Change in Inflammatory Markers as measured by blood C-reactive protein (CRP). | This will be measured to assess clinical response as determined by a reduction of 50% or more from baseline or normalization of the CRP level results. | Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet | 
| Change in inflammatory markers as measured by fecal calprotectin lab results | This will be measured to assess clinical changes as determined by a reduction of 50% or more from baseline or normalization of the calprotectin levels results. | Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in taxonomic composition of the gut microbiome as measured by Polymerase Chain Reaction (PCR) analysis. | This will be measured to assess the impact of time restricted feeding on intestinal microbiota composition. | Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet | 
| Markers of systemic peripheral blood immunity as measured by Mass Cytometry by Time-Of-Flight (CyTOF) analysis. | This will be measured to assess the effect of time restricted feeding on immune cell composition. | Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD, Fasting, Time Restricted Feeding, Intermittent Fasting, Inflammatory Bowel Diseases (IBD), CD