Diet Study on Ulcerative Colitis

Dietary Control of Fat to Modify Colonic Inflammation in Ulcerative Colitis

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: LFD; Other: SAD

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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
13. Failure to meet any of the inclusion criteria
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; 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.
Experimental: 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.	Other: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ulcerative Colitis (UC) symptoms as measured by the partial Mayo score	The partial Mayo score ranges from 0 to 9 with a higher score indicating worsening UC symptoms.	Baseline, 4 weeks
Change in UC symptoms as measured by the Simple Clinical Colitis Activity Index (SCCAI)	SCCAI score ranges from 0 to 19 with a higher score indicating worsening UC symptoms.	Baseline, 4 weeks
Rate of adherence to fat intake	Adherence to fat intake is measured by the web-based daily food diary software Nutrihand.	Baseline, 4 weeks
Rate of adherence to diet items	Adherence to diet items is measured by the web-based daily food diary software Nutrihand.	Baseline, 4 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Broad Medical Research Program Crohn's and Colitis Foundation
• Investigators: Principal Investigator: Maria Abreu, MD, University of Miami

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2015
• Primary Completion (Actual): September 11, 2018
• Study Completion (Actual): September 11, 2018

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: IBD; diet; Inflammatory bowel disease; low fat; UC
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 20130716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No