Designing a Personalized Diet to Reduce the Risk of Crohn's Disease Onset
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Personalized model
研究概览
简要总结
The purpose of this trial is to run a pilot study that examines the impact of different dietary components on risk factors such as the Genetic, Environmental, Microbial (GEM) Microbiome Risk Score (GMRS) and fecal calprotectin (FCP), a marker of inflammation in the bowels, and a risk factor for developing Crohn's disease (CD) among first degree relatives (parents, siblings, or offspring) of Crohn's patients. The study will utilize the Western diet and the Mediterranean diet to explore the complex interplay between diet, microbiome, and inflammatory biomarkers to identify specific dietary components that may be beneficial in reducing the risk of developing CD. The study will enroll 30 participants from Mount Sinai Hospital in Toronto.
详细描述
This study is a clinical trial that will occur at Mount Sinai Hospital and healthy first degree relatives of CD patients will be recruited. Participation will occur over 7 weeks with 1 week of consuming the subject's regular diet and 6 weeks of intervention. A total of 30 subjects are expected to be enrolled into this trial. As part of this trial, The study will attempt to modify dietary consumption between the Western Diet (WD) and the Mediterranean Diet (MD) to evaluate participants responses to specific food items key to the WD or MD by monitoring subject's GMRS and FCP. Subjects will be randomized into one of two groups (1:1), in which there will be crossover between the two diets. Stool samples will be collected 3 times a week, a daily questionnaire and a daily consumption diary will be completed through an app.
Group 1 will follow the WD for weeks 2 and 3, switch to the MD for weeks 4 and 5, and then back to the WD for weeks 6 and 7. Group 2 will follow the MD for weeks 2 and 3, switch to the WD for weeks 4 and 5, and then back to the MD for weeks 6 and 7.
Meal plans developed by the study Dietitian and recipes will be provided for all weeks of the intervention (weeks 2-7). These meal plans will be identical for subjects within the same group. Groceries required to prepare the meals as per the meal plan will be provided to subjects on a weekly basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, asymptomatic first degree relative (child or sibling) of someone with Crohn's disease
- •Have at least 1 bowel movement every other day
排除标准
- •Received antibiotic treatment within 3 months of recruitment
- •Unintentional weight loss in the last 3 months more than 15% of baseline weight
- •Have ever been diagnosed with any chronic or recurring gastro-intestinal disease or bowel disease
- •Belly pain occurred more than once per week for longer than three months in the past year
- •Diarrhea (>three times per day) has been occurring for more than three months in the last year
- •Have blood in their stool with most stools
- •Diagnosed with diabetes
- •Diagnosed with Celiac disease
- •Diagnosed with irritable bowel syndrome
- •Diagnosed with inflammatory bowel disease
- •Presents significant symptoms of gastrointestinal disease
- •Pregnant or breastfeeding women
- •Has any serious food allergies
- •Diagnosed with lactose intolerance
- •Unable to stop NSAID or probiotic use during the study
结局指标
主要结局
Personalized model
时间窗: 7 weeks
Repeated measures of FCP and GMRS will be used to generate a personalized model identifying food items that provide are predicted to have the greatest effect in the GMRS and FCP levels for a given individual
次要结局
- Adherence to the interventions(6 weeks)
- Ability to maintain a balanced diet as measured by food intake records(6 weeks)
- Measure of microbial taxa relative abundance over time during each intervention(Duration of each diet (2 to 4 weeks))
- Concentration of FCP levels over time during each intervention(Duration of each diet (2 to 4 weeks))
- Modulation of GMRS over time during each intervention(Duration of each diet (2 to 4 weeks))
研究者
Ken Croitoru
Clinician Scientist
Mount Sinai Hospital, Canada