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NCT Number: NCT04271748

The Impact of Time Restricted Feeding in Crohn's Disease

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.

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Key information

Conditions

Crohn's Disease (CD) Behavior Crohn Disease Digestive System Diseases Fasting Feeding Behavior Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intermittent Fasting Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Time Restricted Feeding

Other

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.

Other names: Intermittent Fasting

Primary outcomes

  1. Change in patient reported outcomes as measured by Patient Recorded Outcome 2 (PRO2) scores.

    Time frame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet

    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.

  2. Change in Inflammatory Markers as measured by blood C-reactive protein (CRP).

    Time frame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet

    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.

  3. Change in inflammatory markers as measured by fecal calprotectin lab results

    Time frame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet

    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.

Secondary outcomes

  1. Change in taxonomic composition of the gut microbiome as measured by Polymerase Chain Reaction (PCR) analysis.

    Time frame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet

    This will be measured to assess the impact of time restricted feeding on intestinal microbiota composition.

  2. Markers of systemic peripheral blood immunity as measured by Mass Cytometry by Time-Of-Flight (CyTOF) analysis.

    Time frame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet

    This will be measured to assess the effect of time restricted feeding on immune cell composition.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • The Kenneth Rainin Foundation

Registry information

Acronym: TRF-CD

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2020
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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