Personalized "Alberta" Diet for Prevention of Relapse in Ulcerative Colitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02093780|
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Behavioral: Alberta Anti-inflammatory diet Behavioral: Canada's Food Guide Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Dietary Approach to Reduce the Frequency of Relapse in Ulcerative Colitis Patients: a Randomized Controlled Clinical Trial Study|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
Experimental: Alberta Anti-inflammatory Diet
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
Patients randomized to Alberta Anti-inflammatory diet will follow a strict menu plan designed by certified dietitian for 6 months.
Active Comparator: Canada's Food Guide Diet
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:
Behavioral: Canada's Food Guide Diet
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.
- Patient relapse rate [ Time Frame: 6 months ]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.
- Time to relapse [ Time Frame: 6 months ]Time from start until clinical relapse (outcome 1)
- Quality of Life improvement [ Time Frame: 6 months ]Improvement of Quality of Life
- change in mucosal inflammation, measured by fecal calprotectin [ Time Frame: 6 months ]Mucosal inflammation, measured by fecal calprotectin at baseline, months 1, 3, 6 or at relapse
- changes in partial Mayo score from baseline [ Time Frame: 6 months ]Partial Mayo disease activity score at the baseline and monthly, and at a relapse
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093780
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2E1|
|Principal Investigator:||Levinus A Dieleman, MD, PhD||University of Alberta|