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

NCT02093780 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-05-02

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Levinus A Dieleman, MD, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02093780 on ClinicalTrials.gov