Clinical trial NCT04271748: The Impact of Time Restricted Feeding in Crohn's Disease
Official title: The Impact of Time Restricted Feeding in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease (CD)
Keywords: Fasting
Time Restricted Feeding
Intermittent Fasting
Inflammatory Bowel Diseases (IBD)
IBD
CD
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: The Kenneth Rainin Foundation
First posted: 2020-02-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in patient reported outcomes as measured by Patient Recorded Outcome 2 (PRO2) scores.
timeFrame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
measure: Change in Inflammatory Markers as measured by blood C-reactive protein (CRP).
timeFrame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
measure: Change in inflammatory markers as measured by fecal calprotectin lab results
timeFrame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
Secondary outcomes:
measure: Change in taxonomic composition of the gut microbiome as measured by Polymerase Chain Reaction (PCR) analysis.
timeFrame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
measure: Markers of systemic peripheral blood immunity as measured by Mass Cytometry by Time-Of-Flight (CyTOF) analysis.
timeFrame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Dana J Lukin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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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.
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