Crohn's Disease (CD)
Conditions
Keywords
Fasting, Time Restricted Feeding, Intermittent Fasting, Inflammatory Bowel Diseases (IBD), IBD, CD
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.
Interventions
OTHERTime 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.
Sponsors
The Kenneth Rainin Foundation
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient reported outcomes as measured by Patient Recorded Outcome 2 (PRO2) scores. | 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). | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in taxonomic composition of the gut microbiome as measured by Polymerase Chain Reaction (PCR) analysis. | 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. | 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. |
Countries
United States
Outcome results
None listed