An interventional study of Mediterranean diet pattern and Habitual diet (control) in Ulcerative Colitis, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-23.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
The Mediterranean Diet Pattern (MDP) has been shown to have beneficial effects on the intestinal bacteria and the immune system in diseases like cancer and diabetes. The aim of this study is to determine if a MDP will have an impact on symptoms, intestinal bacteria and the immune system in Ulcerative Colitis (UC). Symptoms, blood and stool will be examined to determine if the MDP results in changes to the intestinal bacteria or immune system.
Few studies have found a single dietary factor as being protective or detrimental against inflammatory bowel disease (IBD), therefore novel diet approaches for the prevention and treatment of IBD are urgently needed. The Mediterranean Diet Pattern (MDP) is associated with improvements in health status and inflammatory markers in healthy individuals and rodent models of colitis. Reductions in inflammatory biomarkers and a "normalization" of the gut microbiota have been shown in patients with Crohn's disease following a MDP. To date, no studies have examined the effect of MDP on disease activity, inflammatory markers or the effects on the microbiome in ulcerative colitis (UC).
This study will examine the effects of a MDP taken by patients with UC on 1) symptoms, clinical and quality of life endpoints and 2) on gut microbiome and fecal immune biomarkers. One hundred subjects and two subjects with UC will be randomly allocated to follow a MDP for 12 weeks or their usual diet (controls). Upon initiation, throughout and completion of each diet, symptoms, clinical and quality of life endpoints will be monitored. Fecal samples will be collected to assess pH, short-chain fatty acid concentrations, bacterial abundance and diversity.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 28 is below the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →University of British Columbia is the lead sponsor of 1,310 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Mediterranean diet pattern x 12 weeks.
Behavioral: Mediterranean diet pattern
Habitual diet (control) x 12 weeks.
Behavioral: Habitual diet (control)
Subjects assigned to the Mediterranean diet pattern arm will receive nutrition advice from a Registered Dietitian (RD). The RD will meet with the subjects (in-person) to provide diet education at randomization, week 3 and week 6 of the intervention. Phone and e-mail follow-up will occur at week 2 and week 9 to provide cooking tips, recipes, videos and answer questions.
Subjects assigned to follow their habitual group will be instructed to make no changes to their diet over 12 weeks.
Simple Clinical Colitis Activity Index (SCCAI)
The SCCAI is a symptom-based disease activity index that uses six clinical parameters: daytime and nocturnal bowel frequency, urgency, amount of blood in the stool, well-being and extraintestinal manifestations. A reduction of SCCAI \>1.5 is considered clinically significant and SCCAI score of \<4 is indicative of remission.
Time frame: Change from baseline to week 12
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Quality of life improvement measured at baseline, week 3, week 6, week 9 and 12.
Time frame: 12 weeks
Fecal microbiota
Fecal microbiota measured by examining microbial taxa from stool at baseline and 12 weeks
Time frame: 12 weeks
Change in mucosal inflammation measured by fecal calprotectin
Change in mucosal inflammation will be measured by fecal calprotectin at baseline and week 12
Time frame: 12 weeks
Change in serum marker of inflammation (serum CRP)
Change in markers of inflammation will be measured by serum CRP
Time frame: 12 weeks
Change in serum marker of inflammation (serum ferritin)
Change in markers of inflammation will be measured by serum ferritin
Time frame: 12 weeks
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of British Columbia