Diet Study on Ulcerative Colitis

NCT ID: NCT04147598

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-25
• Study Completion Date: 2018-09-11

Brief Summary

The primary purpose of this study is to determine the effectiveness of a low-fat or standard American diet (high in fat) in helping people with ulcerative colitis improve their symptoms and the signs of inflammation in blood tests and in bowel biopsies.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Low Fat Diet (LFD) to Standard American Diet (SAD)

Week 1 to 4 participants will receive a LFD followed by a washout period of 2 weeks and then week 6 to 10 SAD.

Group Type: EXPERIMENTAL

LFD

Intervention Type: OTHER

Participants will receive daily prepared food trays to achieve a diet with approximately 10% of total fat, 1-5% of calories from saturated fat, and 5-9% of MUFA and PUFA. This diet will contain an approximate ratio of 1:1 of omega-6/omega-3 fatty acids.

SAD

Intervention Type: OTHER

Participants will receive daily prepared food trays to achieve a diet with approximately 35-40% of calories from fat, 10-11% of saturated fats, and 25-29% would be mono-unsaturated (MUFA) and PUFA. This diet will contain a 20-30:1 ratio of omega-6/omega-3 fatty acids, representing the current SAD.

SAD to LFD

Week 1 to 4 participants will receive a SAD followed by a washout period of 2 weeks and then week 6 to 10 LFD.

Group Type: EXPERIMENTAL

LFD

Intervention Type: OTHER

Participants will receive daily prepared food trays to achieve a diet with approximately 10% of total fat, 1-5% of calories from saturated fat, and 5-9% of MUFA and PUFA. This diet will contain an approximate ratio of 1:1 of omega-6/omega-3 fatty acids.

SAD

Intervention Type: OTHER

Participants will receive daily prepared food trays to achieve a diet with approximately 35-40% of calories from fat, 10-11% of saturated fats, and 25-29% would be mono-unsaturated (MUFA) and PUFA. This diet will contain a 20-30:1 ratio of omega-6/omega-3 fatty acids, representing the current SAD.

Interventions

LFD

Participants will receive daily prepared food trays to achieve a diet with approximately 10% of total fat, 1-5% of calories from saturated fat, and 5-9% of MUFA and PUFA. This diet will contain an approximate ratio of 1:1 of omega-6/omega-3 fatty acids.

Intervention Type: OTHER

SAD

Participants will receive daily prepared food trays to achieve a diet with approximately 35-40% of calories from fat, 10-11% of saturated fats, and 25-29% would be mono-unsaturated (MUFA) and PUFA. This diet will contain a 20-30:1 ratio of omega-6/omega-3 fatty acids, representing the current SAD.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male or Female ≥18 and ≤70 years old

2. History of UC of at least 3 months duration

3. UC should be confirmed by colonoscopy within two years of entry into the study

4. Patients with mild to moderate UC, or patients in remission that have had active disease within the past 18 months, regardless of treatment with mesalamines, immunosuppressants, anti-TNFs and/or vedolizumab

• Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥2 weeks prior to screening
• Patients treated with anti-TNFs or immunosuppressants (AZA, 6-MP, or methotrexate) at screening must have been on a stable dose for ≥8 weeks and remain on the same dose during the treatment period
• Patients on steroids can be on no more than prednisone 20mg daily or budesonide 9mg daily at screening. If clinically indicated, tapering of steroids after 4 weeks of intervention may occur. Prednisone may be tapered by no more than 2.5mg/week and budesonide by no more than 3mg/week.
• Patients on infliximab, premedication may include intravenous corticosteroid

5. No antibiotic use or probiotic use within 4 weeks prior to screening

6. Signed written informed consent for enrollment into the study

14. Poor compliance with diet during the study period

15. Failure to submit stool samples as indicated at each phase of the study

16. The need for antibiotic use during the study period

Exclusion Criteria

1. Patients with Crohn's Disease and Celiac Disease

2. History of colonic dysplasia except for adenoma on prior surveillance colonoscopy

3. Patients with altered anatomy: prior colectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy

4. Clinical manifestations concerning for fulminant disease or toxic megacolon

5. Patients with stool sample positive at during screening period or at least <12 weeks for ova, parasites, or culture for aerobic pathogens including: Aeromonas, Plesiomonas, Shigella, Yersinia, Campylobacter and E.coli spp. or positive for Clostridium difficile B toxin in stools

6. Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening

7. Need for prednisone >20mg daily or budesonide >9mg daily at the time of screening

8. Received intravenous corticosteroids within 2 weeks prior to screening, during screening, or during the study period, except as premedication for anti-TNFs

9. Use of Total Parenteral Nutrition at the time of screening and during the study period

10. Anti-diarrheal use within 2 weeks prior to screening

11. Presence of any of the following laboratory abnormalities during screening period or at least <12 weeks

• Hemoglobin <8.0g/dl
• Albumin <2.8g/dl

12. Conditions/situations such as:

• Patients with short life expectancy
• Uncooperative behavior or any condition that could make the patient potentially non-compliant to the study procedures
• Patients with pacemaker
• Other significant or life-threatening co-morbidities in which diet intervention could negatively affect

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Broad Medical Research Program Crohn's and Colitis Foundation

UNKNOWN

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Maria Abreu

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Abreu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

References

Fritsch J, Garces L, Quintero MA, Pignac-Kobinger J, Santander AM, Fernandez I, Ban YJ, Kwon D, Phillips MC, Knight K, Mao Q, Santaolalla R, Chen XS, Maruthamuthu M, Solis N, Damas OM, Kerman DH, Deshpande AR, Lewis JE, Chen C, Abreu MT. Low-Fat, High-Fiber Diet Reduces Markers of Inflammation and Dysbiosis and Improves Quality of Life in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1189-1199.e30. doi: 10.1016/j.cgh.2020.05.026. Epub 2020 May 20.

Reference Type: DERIVED

PMID: 32445952 (View on PubMed)

Other Identifiers

20130716

Identifier Type: -

Identifier Source: org_study_id