Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
- Conditions
- Crohn Disease
- Interventions
- Other: Diet
- Registration Number
- NCT03058679
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
This protocol is designed to compare the effectiveness of two dietary interventions for patients with Crohn's disease (CD): the Specific Carbohydrate Diet (SCD) and a Mediterranean style diet (MSD) that has been demonstrated to have numerous other health benefits. The two diets will be compared in terms of their ability to resolve both the symptoms and bowel inflammation that characterize this debilitating disease.
- Detailed Description
This study tested whether the SCD is superior to a MSD for managing symptoms and reducing inflammatory markers in patients with CD.
The study was designed to include 194 patients with CD who have 1) active symptoms defined by a short Crohn's Disease Activity Index (sCDAI) score \>175. Although the initial plan was to also require that all patients have active inflammation documented by a fecal calprotectin (FCP) concentration \>250mcg/g or high sensitivity C-reactive protein (CRP) \>7 mg/L or ulceration of the small bowel and/or colon consistent with an SES-CD score \>4 as documented in routine clinical practice within 4 weeks of screening, a decision was made early in the recruitment period to enroll all patients with CD with sCDAI\>175 regardless of the results of the tests for inflammatory markers and to perform subgroup analyses of those with and without evidence of inflammation.
Eligible participants were randomly assigned to follow one of the diets in a 1:1 ratio. Participants were provided with 3 meals and 2 snacks each day for a period of 6 weeks. The meals and snacks were prepared by the food vendor, Healthy Chef Creations, and were delivered directly to the participant's home once per week. Participants in both groups were also provided with instructions on how to follow the diets on their own. Participants reported their symptoms through an electronic diary and provided stool samples for FCP measurement and blood for CRP measurement at weeks 0, 6 and 12. The primary and secondary outcomes were assessed at week 6. Following week 6, participants were able to pay out of pocket to purchase food from Healthy Chef Creations and/or could attempt to follow their assigned diet completely on their own. At week 12, in addition to the primary and secondary outcomes assessed again
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Specific Carbohydrate Diet Diet For the first six 6 weeks of the trial, participants received a weekly delivery of prepared meals compliant with the SCD (breakfast, lunch, dinner, and two 2 snacks per day). Meals were prepared by Healthy Chef Creations (Orlando, FL) based on menus developed by the food vendor in consultation with study dietitians. Participants assigned to the SCD received a three3-day starter diet as recommended in Breaking the Vicious Cycle. Meals were designed to be heated in an oven or microwave. No other preparation was required. Mediterranean Style Diet Diet For the first six 6 weeks of the trial, participants received a weekly delivery of prepared meals compliant with the MD (breakfast, lunch, dinner, and two 2 snacks per day). Meals were prepared by Healthy Chef Creations (Orlando, FL) based on menus developed by the food vendor in consultation with study dietitians. Meals were designed to be heated in an oven or microwave. No other preparation was required.
- Primary Outcome Measures
Name Time Method Percentage of Participants That Achieved Symptomatic Remission at Week 6 6 weeks Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being; sCDAI \<150 in the absence of initiation or increase of any CD medications
Reduction in Bowel Inflammation Among Those Whose Screening Fecal Calprotectin (FC) Was Greater Than 250μg/g at Baseline and Who Had an FC Results at Both Baseline and Week 6 6 weeks reduction of calprotectin to less than 250 μg/g and by greater than 50% from screening among those with screening FC \>250 μg/g
- Secondary Outcome Measures
Name Time Method Percentage of Participants That Reached Clinical Remission at Week 6 6 weeks Assessed by the CDAI - CDAI \<150
Percentage of Participants With a Reduction in Systemic Inflammation at Week 6 6 weeks reduction in high-sensitivity CRP (hsCRP) to \<5 mg/L and \>50% reduction from screening among those with screening hsCRP \>5mg/L
Trial Locations
- Locations (35)
Weill Cornell - NewYork Presbyterian
🇺🇸New York, New York, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Atrium Health (formerly Carolinas HealthCare System)
🇺🇸Charlotte, North Carolina, United States
Minnesota Gastroenterology, P.A
🇺🇸Plymouth, Minnesota, United States
Troy Gastroenterology
🇺🇸Troy, Michigan, United States
Lifespan Health System
🇺🇸Providence, Rhode Island, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States
UCSF Colitis and Crohn's Disease Center
🇺🇸San Francisco, California, United States
University of Colorado Denver
🇺🇸Denver, Colorado, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Atlanta Gastroenterology
🇺🇸Atlanta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
NorthShore University HealthSystem
🇺🇸Evanston, Illinois, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Indiana University Health University Hospital
🇺🇸Indianapolis, Indiana, United States
University of Maryland Baltimore
🇺🇸Baltimore, Maryland, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
The University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Ohio State University - Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Clinical Research Institute of Michigan
🇺🇸Chesterfield, Michigan, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
The University of Louisville
🇺🇸Louisville, Kentucky, United States
The University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States