Diet Study on Ulcerative Colitis

NCT04147598 | Completed DMC

• 1 other identifier: 20130716
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Keywords

Inflammatory bowel disease; diet; low fat; UC; IBD

Outcome Measures

Primary Outcomes (6)

• Change in quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ).

  sIBDQ is a 10-item shortened version of the original IBDQ assessing quality of life (QOL) with total scores ranging from 1 to 7 with a higher score indicating a better QOL.

  Baseline, 4 weeks

• Change in quality of life as measured by the Food-Related Quality of Life (FR-QoL-29) Questionnaire.

  FR-QoL-29 is a 29-item questionnaire assessing quality of life (QOL) with total scores ranging from 29 to 145 with a score less than 90 suggesting poor food related QoL.

  Baseline, 4 weeks

• Change in quality of life as measured by the Medical Outcomes Short Form-36 (SF-36) Questionnaire.

  SF-36 is a 36-item questionnaire assessing quality of life (QOL) with total scores ranging from 0 to 100 with a higher score indicating a better QOL.

  Baseline, 4 weeks

• Change in the expression of inflammatory markers in the colon.

  Change in the expression of interleukin (IL)-1β, IL-6 and Tumor Necrosis Factor alpha (TNFa) evaluated in pg/mL.

  Baseline, 4 weeks

• Change in the expression of cytokine in the colon.

  Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluted in mg/L.

  Baseline, 4 weeks

• Change in intestinal microbiota

  Change in relative abundance of the microbial communities evaluated as a percentage.

  Baseline, 4 weeks

Secondary Outcomes (4)

• Change in Ulcerative Colitis (UC) symptoms as measured by the partial Mayo score

  Baseline, 4 weeks

• Change in UC symptoms as measured by the Simple Clinical Colitis Activity Index (SCCAI)

  Baseline, 4 weeks

• Rate of adherence to fat intake

  Baseline, 4 weeks

• Rate of adherence to diet items

  Baseline, 4 weeks

Study Arms (2)

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

EXPERIMENTAL

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

Other: LFD; Other: SAD

SAD to LFD

EXPERIMENTAL

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

Other: LFD; Other: SAD

Interventions

LFD 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.

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

SAD 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.

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female ≥18 and ≤70 years old
• History of UC of at least 3 months duration
• UC should be confirmed by colonoscopy within two years of entry into the study
• 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
• No antibiotic use or probiotic use within 4 weeks prior to screening
• Signed written informed consent for enrollment into the study

You may not qualify if:

• Patients with Crohn's Disease and Celiac Disease
• History of colonic dysplasia except for adenoma on prior surveillance colonoscopy
• Patients with altered anatomy: prior colectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
• Clinical manifestations concerning for fulminant disease or toxic megacolon
• 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
• Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening
• Need for prednisone \>20mg daily or budesonide \>9mg daily at the time of screening
• Received intravenous corticosteroids within 2 weeks prior to screening, during screening, or during the study period, except as premedication for anti-TNFs
• Use of Total Parenteral Nutrition at the time of screening and during the study period
• Anti-diarrheal use within 2 weeks prior to screening
• Presence of any of the following laboratory abnormalities during screening period or at least \<12 weeks
• Hemoglobin \<8.0g/dl
• Albumin \<2.8g/dl
• Conditions/situations such as:
• Patients with short life expectancy

Sponsors & Collaborators

• University of Miami: lead
• Broad Medical Research Program Crohn's and Colitis Foundation: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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.

  PMID: 32445952 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Maria Abreu, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: February 25, 2015
• Primary Completion: September 11, 2018
• Study Completion: September 11, 2018
• Last Updated: November 1, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)