Personalized "Alberta" Diet for Prevention of Relapse in Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

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.
    

Detailed description: 
      Recent research suggests that habitual dietary may play an important part in the treatment of
      inflammatory bowel disease (IBD), but this has not been systematically explored. Habitual
      intake of a diet that is rich in "anti-inflammatory" nutrients (e.g. n-3 fatty acids,
      polyphenols), soluble fiber and other prebiotics (e.g. inulin), and probiotics (that improve
      gut microbiota) may lead to major improvements in IBD disease. Ultimately, the investigators
      are interested in studying the extent to which habitually eating foods, sources of these
      important nutrients and dietary components, might help people with IBD living in Alberta.
      Thus, the information about nutrients and dietary components must be translated to foods and
      dietary patterns that are acceptable and accessible to people in Alberta. This study will
      compare the effectiveness of 2 different approaches, either a structured, personalized menu
      plan constructed with a dietitian (intervention group) vs. general advice to follow Canada's
      Food Guide by a dietitian (control group), to promoting uptake and adherence to an
      appropriate diet. The control group will receive the same care as the intervention group as
      far as access to a registered dietitian. In the intervention group, the nutritional advice
      offered will be to follow a structured four-week menu plan that includes recipes and
      nutrition tips. The menu plan emphasizes specific foods that have been shown in the
      literature to improve IBD symptoms. In the control group, the nutritional advice will be
      general and will emphasize the principles outlined in Canada's Food Guide. Each control
      participant will be provided with their daily serving size allowance for each of the four
      food groups. Each participant will have sole responsibility in deciding which foods are
      selected from each food group; specific foods will not be highlighted.

      Objectives: To evaluate if the proposed Alberta anti-inflammatory diet is effective for the
      prevention of relapses in ulcerative colitis as well as to determine their protective
      mechanisms

      Study Design: Randomized controlled clinical trial Study Population and Number of Subjects:
      70 patients with ulcerative colitis in clinical remission Duration of Treatment: 6 months
      Primary Endpoint: Patient relapse rate over 6 months Secondary Endpoints: Changes in: 1) Time
      to relapse; 2) Patients' quality of life during the study period; 3) Mucosal inflammation,
      measured by fecal calprotectin at baseline, months 1, 3, 6 or at relapse; 4) Partial Mayo
      score at the baseline and monthly, or at a relapse; 5) Laboratory markers of inflammation

      Subject visits:

        1. Screening Visit

             -  Assessment of inclusion of exclusion criteria

             -  Obtainment of Informed Consent

             -  Medical History

             -  Pregnancy Test

             -  Partial Mayo score

        2. Visit Month 0 (baseline), 1, 3, 6 (or at relapse)

             -  Focused Physical Exam and Medical History

             -  Partial Mayo score

             -  Fecal samples for Calprotectin and luminal microflora analysis

             -  Blood and urine samples for metabolomic analysis, inflammatory markers and other
                tests specified in the appendix 2.

             -  Dietary counseling

             -  Questionnaires specified in the appendix 2.

             -  Sigmoidoscopy (only at relapse)

        3. Visit at Month 2, 4, 5

             -  Telephone interview by the dietician

             -  Partial mayo score

             -  Questionnaires specified in the appendix 2

      Studies to Evaluate Mechanisms of Action of the Alberta anti-inflammatory diet:

        -  Compositional changes of the intestinal microbiota in fecal samples, using
           pyrosequencing

        -  Host and microbial metabolomics in serum and urine samples using gas chromatography and
           nuclear magnetic resonance

        -  Evaluations of inflammatory markers (fecal calprotectin, serum interleukin (IL) -6,
           C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and lipopolysaccharide
           (LPS).
    

Intervention name(s): Alberta Anti-inflammatory diet; Canada's Food Guide Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients randomized to Alberta Anti-inflammatory diet will follow a strict menu plan designed by certified dietitian for 6 months.; 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.
Intervention MeSH terms: Anti-Inflammatory Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention