Predicting Microbiome-Associated Personalized Responses to the Mediterranean Diet
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Microbiome - Microbial Diversity
研究概览
简要总结
People respond differently to various diets-some may see significant benefits, while others may not. This project aims to personalize dietary recommendations by analyzing the gut microbiome to predict who will benefit most from the Mediterranean diet based on their unique biology, including their microbiome.
The study focuses on answering these key questions:
- Are there specific microbes that influence who is most likely to benefit from the Mediterranean diet?
- What changes occur in the gut microbiome when healthy individuals follow a Mediterranean diet?
To explore these questions, researchers will compare the effects of a Mediterranean diet to a Western-style diet. Participants will receive all their meals and snacks for the study to ensure accurate comparisons of how these diets impact the gut microbiome.
详细描述
Understanding the role of therapeutic dietary interventions in treating chronic diseases requires acknowledging that the response to nutrition varies in populations, subgroups and individual's. Varying responses to dietary intervention is dependent on interpersonal differences and environment. Personalized nutrition addresses these differences between individuals to maximize the benefits of dietary interventions. Many large, randomized controlled trials have effectively demonstrated that only 40% of a study cohort responds to dietary interventions, and lifestyle measures in regards to reducing disease risk. A more pragmatic approach to enhance the effectiveness of dietary treatment emerges by identifying microbiome-derived biomarkers capable of predicting and categorizing those most likely to benefit from specific nutritional interventions. Developing a predictive microbiome signature represents an advancement in this endeavour, offering the prospect of tailored, personalized nutrition interventions and a comprehensive understanding of the intricate interplay between diet, gut microbiota composition, and human health. Specifically, the Mediterranean diet (MD) has been investigated as a therapeutic diet for varying diseases due to its positive correlation with an array of health benefits. However, there is little consensus on specific microbial changes associated with the MD and how the MD alters the gut microbiome. This study aims to fill this knowledge gap that exists surrounding the MD and to determine a predictive microbiome associated with the MD. Ultimately producing a highly predictive microbiome signature that will have the ability to identifies those who will respond to the MD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants, defined as free from cardiovascular disease, diabetes, and hypertension
- •Body Mass Index of 20-25
- •Between the ages 20-50 years
- •Low adherence to the Mediterranean diet (MD serving score [MDSS] less than 10 points).
- •Must live in the Okanagan area
排除标准
- •Individuals with a self-reported history of irritable bowel syndrome, inflammatory bowel disease, Type-2 diabetes, kidney disease, intestinal obstruction, infectious gastroenteritis, colitis or gastritis, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated), malabsorption (such as celiac disease), major surgery of the GI tract, or colorectal cancer
- •Oral antibiotics within three months of the intervention start date
- •Individuals with any known food allergies, reported dietary intolerances of any kind, and those with eating disorders
- •Pregnant or breastfeeding
- •Participants with a high MDSS (> 10 points)
- •Individuals who are intermittent fasting or refuse to follow the study protocol
研究组 & 干预措施
Mediterranean Diet
During the Mediterranean Diet (MD) phase, participants will receive three meals and two snacks per day for three weeks, adhering to the MD guidelines. To monitor compliance, participants will log their daily appetite and record any uneaten food. Additionally, participants will meet with the Research Coordinator weekly to receive guidance and support throughout the nutrition intervention.
干预措施: Mediterranean diet (Other)
Westernized Diet
During the Westernized Diet phase, participants will receive three meals and two snacks per day for three weeks, following a Westernized diet plan. To ensure compliance, participants will log their daily appetite and record any uneaten food. They will also meet with the Research Coordinator weekly for additional support and guidance.
干预措施: Westernized Diet (Other)
Washout Period
This will be the period between two different interventions where participants will consume their usual diet while we wait for the participants' microbes to normalize after the first intervention before beginning the next one.
结局指标
主要结局
Microbiome - Microbial Diversity
时间窗: Baseline, Week 3, Week 9 and Week 12
Metagenomic sequencing will be employed to analyze stool samples, focusing on changes in the taxonomic composition of the gut microbiome in healthy individuals in response to interventions with the Mediterranean and Western diets.
Microbiome - Microbial Signature
时间窗: Baseline, Week 3, Week 9 and Week 12
Metagenomic sequencing will be utilized to analyze stool samples, aiming to identify microbial signatures of the gut microbiome in healthy individuals following interventions with the Mediterranean and Western diets.
次要结局
- Metabolomics - Change in fecal metabolites(Baseline, Week 3, Week 9 and Week 12)
- Metabolomics - Change in serum metabolites(Baseline, Week 3, Week 9 and Week 12)
- Change in Quality of Life(Baseline, Week 3, Week 9, Week 12)
- Dietary intake(Baseline, Week 9)
- Appetite rating(The Visual Analog Scales (VAS) for Appetite will be completed daily throughout the dietary intervention period, which includes 3 weeks on the Mediterranean diet and 3 weeks on the Western diet.)
- Change in Anxiety(Baseline, Week 3, Week 9 and Week 12)
- Change in Depression(Baseline, Week 3, Week 9 and Week 12)
研究者
Natasha Haskey
Research Associate, Department of Biology
University of British Columbia