Personalized "Alberta" Diet for Prevention of Relapse in Ulcerative Colitis

NCT02093780 | Completed

• 1 other identifier: Pro00035413
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

In the present study, ulcerative colitis (UC) patients in the remission stage of the disease will be randomized into two groups: Alberta anti-inflammatory diet and Canada's Food Guide diet. The elements of Alberta anti-inflammatory diet have previously been shown to have a role in decreasing the risk of UC development or management of UC-related symptoms or relapse. Since the primary outcome of interest is the relapse rate in two groups, disease status will be assessed monthly using appropriate tools. In order to find out the underlying mechanisms that will relate the proposed diet to decreased flare rate, some laboratory evaluations, which are mainly markers of inflammation or are related to gut microbiome will be conducted. In the present study, the investigators will also perform state-of-the art metabolomics tests, in order to study how the dietary changes will change the end metabolites. In addition, the investigators will be able to explore if metabolomic profile of participants can predict future UC relapse. This study will last for 6 months from baseline wherein all the study subjects will receive appropriate dietary instructions in addition to their stable doses of maintenance drug therapy.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Patient relapse rate

  Relapse is defined as the total partial Mayo score exceeds 2. Partial Mayo score represents a sum of the subject's symptoms for rectal bleeding and stool frequency, as well as a physician global assessment score, each of them scored from 0 to 3.

  6 months

Secondary Outcomes (4)

• Time to relapse

  6 months

• Quality of Life improvement

  6 months

• change in mucosal inflammation, measured by fecal calprotectin

  6 months

• changes in partial Mayo score from baseline

  6 months

Study Arms (2)

Alberta Anti-inflammatory Diet

EXPERIMENTAL

Patients randomized into this group will receive a dietary menu plan that contains anti-inflammatory foods/nutrients that have been shown to be effective in the management of IBD in previous studies. The main aim of this diet will be to increase dietary intakes of prebiotics/probiotics, omega 3 fatty acids, fiber (soluble), antioxidants and decrease dietary intake of red and processed meat.

Behavioral: Alberta Anti-inflammatory diet

Canada's Food Guide Diet

ACTIVE COMPARATOR

Patients that have been randomized into this group will receive simple dietary recommendations based on the Canada's Food Guide. The details of Canada's Food Guide can be available here: http://www.hc-sc.gc.ca/fn-an/food-guide-aliment/index-eng.php

Behavioral: Canada's Food Guide Diet

Interventions

Alberta Anti-inflammatory diet BEHAVIORAL

Patients randomized to Alberta Anti-inflammatory diet will follow a strict menu plan designed by certified dietitian for 6 months.

Alberta Anti-inflammatory Diet

Canada's Food Guide Diet BEHAVIORAL

Patients randomized to Canada's Food Guide diet will receive counseling by certified dietitian for 6 months and will design their own diet following Canada's Food Guide.

Canada's Food Guide Diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have Ulcerative Colitis in clinical remission (partial Mayo score of less than 2)
• Fecal calprotectin of more than 150 microgram/g
• Patients on oral 5-ASA drugs and/or Azathioprine or 6-mercaptopurine as long as the dose has been stable for 2 weeks (between 2-2.4 gram daily for oral 5-ASA) or 2 months (for azathioprine or 6-mercaptopurine).
• Participants must be generally healthy besides having UC
• Must be able to communicate in English.
• Live in the Edmonton Area.

You may not qualify if:

• Use of prednisone (or steroid equivalent) at the time of enrollment.
• Use of anti-TNF drugs within 3 months of enrollment.
• Use of antibiotics (washout period of at least 2 weeks is required).
• Pregnancy or lactation.
• History of colectomy.
• Significant chronic disorders such as severe cardiac disease, significant renal failure, severe pulmonary disease (need for oxygen).
• Active gastrointestinal infection.
• Severe psychiatric disorder.
• Unable or unwilling to consent

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

Related Publications (2)

• Olendzki BC, Silverstein TD, Persuitte GM, Ma Y, Baldwin KR, Cave D. An anti-inflammatory diet as treatment for inflammatory bowel disease: a case series report. Nutr J. 2014 Jan 16;13:5. doi: 10.1186/1475-2891-13-5.

  PMID: 24428901 BACKGROUND

• Richman E, Rhodes JM. Review article: evidence-based dietary advice for patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1156-71. doi: 10.1111/apt.12500. Epub 2013 Sep 17.

  PMID: 24102340 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Officials

• Levinus A Dieleman, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: March 21, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: May 2, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)