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

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ClinicalTrials.gov Identifier: NCT04271748
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : February 2, 2021
Sponsor:
Collaborator:
The Kenneth Rainin Foundation
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease (CD) Other: Time Restricted Feeding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Time Restricted Feeding in Crohn's Disease
Actual Study Start Date : January 14, 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Time Restricted Feeding
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
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 Name: Intermittent Fasting




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04271748


Contacts
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Contact: Lucia F Duenas-Bianchi, BS 646-697-0985 lfd4001@med.cornell.edu
Contact: Fatiha Chabouni, MD 212-746-5109 fac2005@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Lucia F Duenas-Bianchi, BS    646-697-0985    lfd4001@med.cornell.edu   
Contact: Fatiha Chabouni, MD    646-697-0985    fac2005@med.cornell.edu   
Principal Investigator: Dana J Lukin, MD, PhD         
Sub-Investigator: Ryan Warren, MS, RD         
Sponsors and Collaborators
Weill Medical College of Cornell University
The Kenneth Rainin Foundation
Investigators
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Principal Investigator: Dana J Lukin, MD, PhD Weill Medical College of Cornell University
Publications:

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04271748    
Other Study ID Numbers: 19-11021081
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Fasting
Time Restricted Feeding
Intermittent Fasting
Inflammatory Bowel Diseases (IBD)
IBD
CD
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases