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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

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

• Principal Investigator: Dana J Lukin, MD, PhD; Weill Medical College of Cornell University

More Information

Publications:

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. Review.

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. Review.

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. Review.

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). pii: E0447. doi: 10.3390/nu9050447. Review.

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.

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.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT04271748
• Other Study ID Numbers: 19-11021081
• First Posted: February 17, 2020
• Last Update Posted: February 2, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases