The Impact of Time Restricted Feeding in Crohn's Disease (TRF-CD)

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Crohn's Disease (CD)

Treatments: Other: Time Restricted Feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT04271748

19-11021081

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Time Restricted Feeding

Experimental group

Description:

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.

Treatment:

Other: Time Restricted Feeding