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 : January 24, 2022
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Condition or disease | Intervention/treatment | Phase |
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Crohn's Disease (CD) | Other: Time Restricted Feeding | Not Applicable |
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 : | November 2022 |
Estimated Study Completion Date : | November 2022 |

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.
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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 |
- 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.
- 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.
- 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.
- 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.
- 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 |
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.

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
Contact: Prerna Mahtani | 646-697-0985 | prm4002@med.cornell.edu | |
Contact: Fatiha Chabouni, MD | 212-746-5109 | fac2005@med.cornell.edu |
United States, New York | |
Weill Cornell Medicine | Recruiting |
New York, New York, United States, 10065 | |
Contact: Prerna Mahtani 646-697-0985 prm4002@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 |
Principal Investigator: | Dana J Lukin, MD, PhD | Weill Medical College of Cornell University |
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: | January 24, 2022 |
Last Verified: | January 2022 |
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 |
Fasting Time Restricted Feeding Intermittent Fasting |
Inflammatory Bowel Diseases (IBD) IBD CD |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |