Recruiting

SCD vs. Mediterranean Diet

Sponsor:

Massachusetts General Hospital

Code:

NCT04398550

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Specific Carbohydrate Diet

Mediterranean Diet

Study Details

Brief summary:

Although patients and physicians have shown tremendous interest in the effect of diet on ulcerative colitis, there is a lack of significant evidence for providers to make practical recommendations with. In this study, the investigators hope to find out if dietary therapy by either the Specific Carbohydrate Diet (SCD) or the Mediterranean diet will help improve ulcerative colitis symptoms for patients with mild to moderately active disease. In addition, the investigators will compare disease activity and changes in the intestinal bacterial composition in the colon that occur with the Mediterranean or the SCD diet in active ulcerative colitis.

This study is proposed as a single-site randomized trial consisting of 10 study visits to Massachusetts General Hospital (MGH) over 12 weeks. Participants in this study will be randomly assigned to the SCD or Mediterranean diet. The investigators ask that participants exclusively consume their assigned diet for 6 weeks, with all meals and snacks prepared by the metabolic kitchen within MGH. Participants will need to pick up food from MGH every 5-7 days, and will meet with a study dietitian before they begin and weekly during the diet therapy.

There will be a screening visit to determine eligibility for the study, as well as study visits at weeks 0, 1, 2, 4, 6, and a 10 week follow-up at MGH, in which participants will fill out questionnaires. Participants will need to provide stool samples at screening, week 6, and week 10. In addition, blood will be drawn at week 0 and week 6, and if participants are getting a clinically-indicated colonoscopy at the time of screening, up to eight research biopsies may be collected during the procedure.

Conditions

Ulcerative Colitis

Study ID

NCT04398550

Start date

Sep 3, 2020

Status verified date

May, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • History of active ulcerative colitis for at least 3 months before screening
  • Ulcerative colitis confirmed by colonoscopy or flexible sigmoidoscopy within 2 years of screening
  • Mild to moderate ulcerative colitis at the time of screening (2 < Mayo score < 12)
  • 1 ≤ Endoscopy subscore ≤ 2, or fecal calprotectin > 150 mcg/g within 2 weeks of screening
  • Patients on 5-aminosalicylates (e.g. mesalamine, etc.) must be on a stable dose for ≥ 4 weeks prior to screening
  • Patients on treatment with immunosuppressive (azathioprine/6-mercaptopurine and methotrexate) or biologic medications (infliximab, adalimumab, and golimumab) must be on stable dose for 8 weeks prior to baseline
  • At the time of baseline, patients may be on no more than 20 mg of prednisone and 9 mg of budesonide MMX

Exclusion Criteria:

  • Patients with Crohn's disease or indeterminate colitis
  • History of colectomy
  • Presence of ileal pouch or ostomy
  • History of colonic dysplasia
  • Evidence of active bacterial or viral gastroenteritis as indicated by positive stool studies for ova \& parasites, clostridium difficile, and stool culture
  • Severe to fulminant colitis
  • Recent hospitalizations (within 2 weeks of screening) for ulcerative colitis requiring IV steroids
  • Recent systemic antibiotics use (within 2 weeks of screening)
  • Presence of the following labs indicative of severe colitis: a. Hemoglobin < 8.0 g/dl b. Albumin < 3.0 g/dl
  • Use of Total Parenteral Nutrition (TPN)
  • Active use of anti-diarrheal medications
  • Use of cyclosporine, tacrolimus, or thalidomide within 2 months prior to screening

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Specific Carbohydrate Diet

Exclusive consumption of the specific carbohydrate diet for 6 weeks

experimental: Mediterranean Diet

Exclusive consumption of the Mediterranean diet for 6 weeks

Interventions

Specific Carbohydrate Diet

Diet restricts all but simple carbohydrates and allows for inclusion of fresh fruits, vegetables, unprocessed meats, and homemade lactose-free cheese and yogurt.

Mediterranean Diet

Diet rich in whole vegetables, fruit, plant-based protein, and olive oil, with moderate amounts of seafood and dairy, and limited in sugar-sweetened goods, red meat, and nutrients like heme and sodium.

Primary outcome measure

  • Partial Mayo Clinic Score [ Time Frame: Week 6 ]

Central Contacts and Locations

Central contacts

Hamed Khalili, MD, MPH

978-882-6709hkhalili@partners.org

Katherine Williams

617-643-9374kwilliams81@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Katherine Williams

617-643-9374kwilliams81@mgh.harvard.edu

Jessica McGoldrick

jmcgoldrick2@mgh.harvard.edu

Principal Investigator:

Hamed Khalili, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 31, 2022

Last verified

May, 2022

Keywords

  • Diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2022-05-31.