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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn's Disease (CD)
• Intervention / Treatment: Other: Time Restricted Feeding

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prerna Mahtani; Phone Number: 646-697-0985; Email: prm4002@med.cornell.edu
• Study Contact Backup: Name: Fatiha Chabouni, MD; Phone Number: 212-746-5109; Email: fac2005@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Prerna Mahtani; Phone Number: 646-697-0985; Email: prm4002@med.cornell.edu
      • Contact: Fatiha Chabouni, MD; Phone Number: 646-697-0985; Email: fac2005@med.cornell.edu
      • Principal Investigator: Dana J Lukin, MD, PhD
      • Sub-Investigator: Ryan Warren, MS, RD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Intermittent Fasting

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: The Kenneth Rainin Foundation
• Investigators: Principal Investigator: Dana J Lukin, MD, PhD, Weill Medical College of Cornell University

Publications and helpful links

General Publications

• Mattson MP, Longo VD, Harvie M. Impact of intermittent fasting on health and disease processes. Ageing Res Rev. 2017 Oct;39:46-58. doi: 10.1016/j.arr.2016.10.005. Epub 2016 Oct 31.
• Patterson RE, Sears DD. Metabolic Effects of Intermittent Fasting. Annu Rev Nutr. 2017 Aug 21;37:371-393. doi: 10.1146/annurev-nutr-071816-064634. Epub 2017 Jul 17.
• Suskind DL, Cohen SA, Brittnacher MJ, Wahbeh G, Lee D, Shaffer ML, Braly K, Hayden HS, Klein J, Gold B, Giefer M, Stallworth A, Miller SI. Clinical and Fecal Microbial Changes With Diet Therapy in Active Inflammatory Bowel Disease. J Clin Gastroenterol. 2018 Feb;52(2):155-163. doi: 10.1097/MCG.0000000000000772.
• Celiberto LS, Graef FA, Healey GR, Bosman ES, Jacobson K, Sly LM, Vallance BA. Inflammatory bowel disease and immunonutrition: novel therapeutic approaches through modulation of diet and the gut microbiome. Immunology. 2018 Sep;155(1):36-52. doi: 10.1111/imm.12939. Epub 2018 May 16.
• Nagai M, Noguchi R, Takahashi D, Morikawa T, Koshida K, Komiyama S, Ishihara N, Yamada T, Kawamura YI, Muroi K, Hattori K, Kobayashi N, Fujimura Y, Hirota M, Matsumoto R, Aoki R, Tamura-Nakano M, Sugiyama M, Katakai T, Sato S, Takubo K, Dohi T, Hase K. Fasting-Refeeding Impacts Immune Cell Dynamics and Mucosal Immune Responses. Cell. 2019 Aug 22;178(5):1072-1087.e14. doi: 10.1016/j.cell.2019.07.047.
• Jordan S, Tung N, Casanova-Acebes M, Chang C, Cantoni C, Zhang D, Wirtz TH, Naik S, Rose SA, Brocker CN, Gainullina A, Hornburg D, Horng S, Maier BB, Cravedi P, LeRoith D, Gonzalez FJ, Meissner F, Ochando J, Rahman A, Chipuk JE, Artyomov MN, Frenette PS, Piccio L, Berres ML, Gallagher EJ, Merad M. Dietary Intake Regulates the Circulating Inflammatory Monocyte Pool. Cell. 2019 Aug 22;178(5):1102-1114.e17. doi: 10.1016/j.cell.2019.07.050.
• MacLellan A, Moore-Connors J, Grant S, Cahill L, Langille MGI, Van Limbergen J. The Impact of Exclusive Enteral Nutrition (EEN) on the Gut Microbiome in Crohn's Disease: A Review. Nutrients. 2017 May 1;9(5):447. doi: 10.3390/nu9050447.
• Khanna R, Zou G, D'Haens G, Feagan BG, Sandborn WJ, Vandervoort MK, Rolleri RL, Bortey E, Paterson C, Forbes WP, Levesque BG. A retrospective analysis: the development of patient reported outcome measures for the assessment of Crohn's disease activity. Aliment Pharmacol Ther. 2015 Jan;41(1):77-86. doi: 10.1111/apt.13001. Epub 2014 Oct 27.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: IBD; CD; Fasting; Intermittent Fasting; Time Restricted Feeding; Inflammatory Bowel Diseases (IBD)
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 19-11021081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No