The Impact of Time Restricted Feeding in Crohn's Disease

Crohn's Disease (CD) Clinical Trial

— TRF-CD  

Official title:

The Impact of Time Restricted Feeding in Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04271748
• Other study ID #: 19-11021081
• Status: Completed
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: January 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 1, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease (CD)

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	The Kenneth Rainin Foundation

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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