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

Primary Purpose

Crohn's Disease (CD)

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Time Restricted Feeding

About this trial

This is an interventional treatment trial for Crohn's Disease (CD) focused on measuring Fasting, Time Restricted Feeding, Intermittent Fasting, Inflammatory Bowel Diseases (IBD), IBD, CD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Weill Cornell Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Time Restricted Feeding

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04271748

First Posted

February 13, 2020

Last Updated

January 30, 2023

Sponsor

Weill Medical College of Cornell University

Collaborators

The Kenneth Rainin Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04271748

Brief Title

The Impact of Time Restricted Feeding in Crohn's Disease

Acronym

TRF-CD

Official Title

The Impact of Time Restricted Feeding in Crohn's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

January 14, 2021 (Actual)

Primary Completion Date

August 16, 2022 (Actual)

Study Completion Date

November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

The Kenneth Rainin Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease (CD)

Keywords

Fasting, Time Restricted Feeding, Intermittent Fasting, Inflammatory Bowel Diseases (IBD), IBD, CD

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Time Restricted Feeding

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Time Restricted Feeding

Other Intervention Name(s)

Intermittent Fasting

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

Change in inflammatory markers as measured by fecal calprotectin lab results

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dana J Lukin, MD, PhD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29693729

Citation

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.

Results Reference

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PubMed Identifier

27810402

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.

Results Reference

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PubMed Identifier

28715993

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.

Results Reference

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PubMed Identifier

31442401

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.

Results Reference

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PubMed Identifier

31442403

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.

Results Reference

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PubMed Identifier

28468301

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.

Results Reference

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PubMed Identifier

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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.

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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.

Results Reference

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The Impact of Time Restricted Feeding in Crohn's Disease

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