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Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease (DINE-CD)

Primary Purpose

Crohn Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring diet, specific carbohydrate diet, Mediterranean style diet, randomized controlled trial

Eligibility Criteria

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

Inclusion Criteria

  1. Age ≥18
  2. Documented diagnosis of Crohn's disease
  3. sCDAI score >175
  4. Documentation of receipt of a baseline stool sample by the data coordinating center and hsCRP.
  5. Access to a computer with internet and the ability to complete daily online surveys
  6. Capable of providing consent to participate
  7. Able to receive weekly food shipments delivered every Friday for 6 weeks

Exclusion Criteria

  1. Pregnancy
  2. sCDAI >400
  3. Hospitalized patients
  4. Anticipated need for surgery within 6 weeks of randomization
  5. Use of the Specific Carbohydrate Diet within 4 weeks of screening
  6. Start or change*** dose of thiopurines (azathioprine and 6-MP), methotrexate, natalizumab, or vedolizumab within 12 weeks prior to screening
  7. Start or change*** dose of anti-tumor necrosis factor (TNF) agents (including infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), golimumab (Simponi) or ustekinumab within 8 weeks prior to screening.
  8. Start or change in dose of any 5-aminosalicylic acid (5-ASA) medications within 2 weeks of screening.
  9. Start or change dose of corticosteroids within 1 week of screening or a dose >20mg/day prednisone or equivalent*
  10. Use of antibiotics (other than topical formulations) for any reason within 2 weeks prior to screening
  11. Known symptomatic intestinal stricture.
  12. Presence of an ostomy
  13. Baseline stool frequency >4 bowel movements/day when well
  14. BMI <16
  15. BMI ≥40
  16. Celiac disease
  17. Documented C difficile colitis within four weeks of screening
  18. Diabetes Mellitus requiring medication
  19. Albumin<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical care)
  20. Known allergy to tree nuts or peanuts
  21. Other conditions that would be a contraindication to any of the study diets or preclude the participant from completing the study.

  22. Currently participating in another clinical trial of a drug to treat Inflammatory Bowel Disease (IBD) or a dietary therapy for any indication.

    • Patients may continue these medications at stable dose for the first six weeks and budesonide may be used at any dose. After the 6th week in the study, patients may taper their steroid dose. The study will provide a recommended taper schedule.

      • Loading/induction doses of biologic type medication will be considered a stable doses. ***Exception for treatment failures: if a subject is determined to fail on any of the following standard lines of treatment at the treating investigator's discretion, subjects may screen for study intervention based upon the following wash out periods: 4 weeks for thiopurine and methotrexate and 8 weeks for natalizumab, vedolizumab, anti-TNF, or ustekinumab.

Sites / Locations

  • University of Arizona
  • UCSF Colitis and Crohn's Disease Center
  • University of Colorado Denver
  • Emory University
  • Atlanta Gastroenterology
  • University of Chicago
  • NorthShore University HealthSystem
  • Northwestern University
  • Indiana University Health University Hospital
  • The University of Louisville
  • University of Maryland Baltimore
  • Boston Children's Hospital
  • Clinical Research Institute of Michigan
  • Troy Gastroenterology
  • The University of Minnesota
  • Minnesota Gastroenterology, P.A
  • Mayo Clinic - Rochester
  • Dartmouth-Hitchcock Medical Center
  • NYU Langone Medical Center
  • Weill Cornell - NewYork Presbyterian
  • Icahn School of Medicine at Mount Sinai
  • Lenox Hill Hospital
  • The University of North Carolina
  • Atrium Health (formerly Carolinas HealthCare System)
  • Wake Forest Baptist Medical Center
  • University of Cincinnati
  • University Hospitals Cleveland Medical Center
  • Ohio State University - Wexner Medical Center
  • University of Pennsylvania
  • University of Pittsburgh Medical Center
  • Lifespan Health System
  • Vanderbilt University Medical Center
  • University of Utah
  • Virginia Mason Medical Center
  • University of Wisconsin-Madison

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Specific Carbohydrate Diet

Mediterranean Style Diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants That Achieved Symptomatic Remission at Week 6
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
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

Percentage of Participants That Reached Clinical Remission at Week 6
Assessed by the CDAI - CDAI <150
Percentage of Participants With a Reduction in Systemic Inflammation at Week 6
reduction in high-sensitivity CRP (hsCRP) to <5 mg/L and >50% reduction from screening among those with screening hsCRP >5mg/L

Full Information

First Posted
February 16, 2017
Last Updated
June 30, 2021
Sponsor
University of Pennsylvania
Collaborators
Patient-Centered Outcomes Research Institute, Crohn's and Colitis Foundation, University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT03058679
Brief Title
Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
Acronym
DINE-CD
Official Title
Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Patient-Centered Outcomes Research Institute, Crohn's and Colitis Foundation, University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
diet, specific carbohydrate diet, Mediterranean style diet, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Specific Carbohydrate Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Mediterranean Style Diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants That Achieved Symptomatic Remission at Week 6
Description
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
Time Frame
6 weeks
Title
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
Description
reduction of calprotectin to less than 250 μg/g and by greater than 50% from screening among those with screening FC >250 μg/g
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants That Reached Clinical Remission at Week 6
Description
Assessed by the CDAI - CDAI <150
Time Frame
6 weeks
Title
Percentage of Participants With a Reduction in Systemic Inflammation at Week 6
Description
reduction in high-sensitivity CRP (hsCRP) to <5 mg/L and >50% reduction from screening among those with screening hsCRP >5mg/L
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Age ≥18 Documented diagnosis of Crohn's disease sCDAI score >175 Documentation of receipt of a baseline stool sample by the data coordinating center and hsCRP. Access to a computer with internet and the ability to complete daily online surveys Capable of providing consent to participate Able to receive weekly food shipments delivered every Friday for 6 weeks Exclusion Criteria Pregnancy sCDAI >400 Hospitalized patients Anticipated need for surgery within 6 weeks of randomization Use of the Specific Carbohydrate Diet within 4 weeks of screening Start or change*** dose of thiopurines (azathioprine and 6-MP), methotrexate, natalizumab, or vedolizumab within 12 weeks prior to screening Start or change*** dose of anti-tumor necrosis factor (TNF) agents (including infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), golimumab (Simponi) or ustekinumab within 8 weeks prior to screening. Start or change in dose of any 5-aminosalicylic acid (5-ASA) medications within 2 weeks of screening. Start or change dose of corticosteroids within 1 week of screening or a dose >20mg/day prednisone or equivalent* Use of antibiotics (other than topical formulations) for any reason within 2 weeks prior to screening Known symptomatic intestinal stricture. Presence of an ostomy Baseline stool frequency >4 bowel movements/day when well BMI <16 BMI ≥40 Celiac disease Documented C difficile colitis within four weeks of screening Diabetes Mellitus requiring medication Albumin<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical care) Known allergy to tree nuts or peanuts Other conditions that would be a contraindication to any of the study diets or preclude the participant from completing the study. Currently participating in another clinical trial of a drug to treat Inflammatory Bowel Disease (IBD) or a dietary therapy for any indication. Patients may continue these medications at stable dose for the first six weeks and budesonide may be used at any dose. After the 6th week in the study, patients may taper their steroid dose. The study will provide a recommended taper schedule. Loading/induction doses of biologic type medication will be considered a stable doses. ***Exception for treatment failures: if a subject is determined to fail on any of the following standard lines of treatment at the treating investigator's discretion, subjects may screen for study intervention based upon the following wash out periods: 4 weeks for thiopurine and methotrexate and 8 weeks for natalizumab, vedolizumab, anti-TNF, or ustekinumab.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D Lewis, MD, MSCE
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
UCSF Colitis and Crohn's Disease Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Colorado Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Atlanta Gastroenterology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Indiana University Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Maryland Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Clinical Research Institute of Michigan
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Troy Gastroenterology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48092
Country
United States
Facility Name
The University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Minnesota Gastroenterology, P.A
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell - NewYork Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
The University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Atrium Health (formerly Carolinas HealthCare System)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State University - Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Lifespan Health System
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34052278
Citation
Lewis JD, Sandler RS, Brotherton C, Brensinger C, Li H, Kappelman MD, Daniel SG, Bittinger K, Albenberg L, Valentine JF, Hanson JS, Suskind DL, Meyer A, Compher CW, Bewtra M, Saxena A, Dobes A, Cohen BL, Flynn AD, Fischer M, Saha S, Swaminath A, Yacyshyn B, Scherl E, Horst S, Curtis JR, Braly K, Nessel L, McCauley M, McKeever L, Herfarth H; DINE-CD Study Group. A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn's Disease. Gastroenterology. 2021 Sep;161(3):837-852.e9. doi: 10.1053/j.gastro.2021.05.047. Epub 2021 May 27. Erratum In: Gastroenterology. 2022 Nov;163(5):1473.
Results Reference
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Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease

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