Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Foundation for Dietetic Research (CFDR) | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean Diet Pattern | Active Comparator | Mediterranean diet pattern x 12 weeks. |
|
| Habitual Diet | Placebo Comparator | Habitual diet (control) x 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet pattern | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | Quality of life improvement measured at baseline, week 3, week 6, week 9 and 12. | 12 weeks |
| Fecal microbiota | Fecal microbiota measured by examining microbial taxa from stool at baseline and 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deanna L Gibson, PhD | University of British Columbia- Okanagan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia - Okanagan | Kelowna | British Columbia | V1V 1V7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27067195 | Background | DeCoffe D, Quin C, Gill SK, Tasnim N, Brown K, Godovannyi A, Dai C, Abulizi N, Chan YK, Ghosh S, Gibson DL. Dietary Lipid Type, Rather Than Total Number of Calories, Alters Outcomes of Enteric Infection in Mice. J Infect Dis. 2016 Jun 1;213(11):1846-56. doi: 10.1093/infdis/jiw084. Epub 2016 Apr 10. | |
| 27306105 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 20, 2024 | |
| Reset | Oct 11, 2024 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 20, 2024 | Oct 11, 2024 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Using a randomized, parallel treatment design, the effects of the Mediterranean diet pattern on symptoms, clinical disease activity, gut microbiome and fecal biomarkers in stable UC patients in remission will be examined. Using this design, we will compare the habitual diet (taken as a "control" diet) to the Mediterranean diet pattern taken by UC patients over a 12-week period.
Not provided
Not provided
Not provided
Not provided
|
| Habitual diet (control) | Behavioral | Subjects assigned to follow their habitual group will be instructed to make no changes to their diet over 12 weeks. |
|
| 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 | 12 weeks |
| Change in serum marker of inflammation (serum CRP) | Change in markers of inflammation will be measured by serum CRP | 12 weeks |
| Change in serum marker of inflammation (serum ferritin) | Change in markers of inflammation will be measured by serum ferritin | 12 weeks |
| Strisciuglio C, Giugliano F, Martinelli M, Cenni S, Greco L, Staiano A, Miele E. Impact of Environmental and Familial Factors in a Cohort of Pediatric Patients With Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):569-574. doi: 10.1097/MPG.0000000000001297. |
| 24283712 | Background | Marlow G, Ellett S, Ferguson IR, Zhu S, Karunasinghe N, Jesuthasan AC, Han DY, Fraser AG, Ferguson LR. Transcriptomics to study the effect of a Mediterranean-inspired diet on inflammation in Crohn's disease patients. Hum Genomics. 2013 Nov 27;7(1):24. doi: 10.1186/1479-7364-7-24. |
| 40242173 | Derived | Haskey N, Ye J, Josephson J, Raman M, Ghosh S, Gibson DL. Metabolomic Signatures Highlight Fiber-Degrading Bacteroides Species in Mediterranean Diet Response Among Ulcerative Colitis. Gastro Hep Adv. 2024 Dec 31;4(4):100606. doi: 10.1016/j.gastha.2024.100606. eCollection 2025. |
| 36618690 | Derived | Haskey N, Shim RCK, Davidson-Hunt A, Ye J, Singh S, Dieleman LA, Jacobson K, Ghosh S, Gibson DL. Dietary adherence to the Mediterranean diet pattern in a randomized clinical trial of patients with quiescent ulcerative colitis. Front Nutr. 2022 Dec 21;9:1080156. doi: 10.3389/fnut.2022.1080156. eCollection 2022. |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |