SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
NCT ID: NCT04398550
Last Updated: 2022-05-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-09-03
Study Completion Date
2023-12-31
Brief Summary
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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.
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.
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Detailed Description
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This randomized, parallel-group feeding study will examine the influence of Mediterranean and SCD diets on gut microbiota, luminal inflammation, and disease-specific clinical indices in patients with mild to moderate ulcerative colitis (UC). 50 patients will be randomized to follow either the SCD or Mediterranean diet in a 1:1 ratio. Once informed consent is obtained, subjects will enter a 2-week screening period. Eligible subjects will be enrolled in the feeding treatment for 6 weeks followed by an additional follow-up visit at 10 weeks (4 weeks after feeding treatment completion). The total time to complete the study is 12 weeks. The metabolic kitchen within the Metabolism and Nutrition Research Center at MGH Translational and Clinical Research (TCRC) Unit will be responsible for preparing and packaging food for participants to pick up, as well as performing all necessary nutritional assessments. Participants will be provided with 3 meals and 2 snacks a day during the 6-week dietary intervention. Patient menus will be identical in each diet and will rotate on a 3-day basis. Total calories for each diet will be tailored according to each participant's body composition.
Conditions
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Ulcerative Colitis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
The investigators, subjects, and remaining study staff will not be intentionally unblinded. Due to the nature of the study, subjects, study staff, and investigators interacting with the subjects will likely be able to figure out what diet the subject is assigned to, however, the exact diet will not be explicitly revealed to them.
Study Groups
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Specific Carbohydrate Diet
Exclusive consumption of the specific carbohydrate diet for 6 weeks
Group Type
EXPERIMENTAL
Specific Carbohydrate Diet
Intervention Type
OTHER
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
Exclusive consumption of the Mediterranean diet for 6 weeks
Group Type
EXPERIMENTAL
Mediterranean Diet
Intervention Type
OTHER
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.
Interventions
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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.
Intervention Type
OTHER
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.
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Massachusetts General Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Hamed Khalili
Assistant Professor of Medicine at Harvard Medical School
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Hamed Khalili, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Halmos EP, Christophersen CT, Bird AR, Shepherd SJ, Gibson PR, Muir JG. Diets that differ in their FODMAP content alter the colonic luminal microenvironment. Gut. 2015 Jan;64(1):93-100. doi: 10.1136/gutjnl-2014-307264. Epub 2014 Jul 12.
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Other Identifiers
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2020P000298
Identifier Type: -
Identifier Source: org_study_id
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