Identification of Objective Metabolomics-based Biomarkers of Yogurt Consumption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Biomarker of yogurt intake
研究概览
简要总结
Substantial evidence links yogurt consumption to a lower risk of type 2 diabetes (T2D). However, the existing evidence is derived exclusively from prospective cohort studies relying on self-reported dietary questionnaires, which-despite being validated-are subject to random and systematic errors that may compromise evidence quality and hinder regulatory approval.
The project aims to discover and validate biomarkers of yogurt intake.
The investigators will conduct a randomized, crossover, dose-response feeding trial involving 16 generally healthy adult participants (8 females, 8 males). The trial will include four 7-day diet periods, each separated by a 1-week washout. All diets will be based on a dairy-free background and supplemented with one of the following: (a) 1 serving of soy-based pudding (no yogurt), (b) 0.5 serving of yogurt, (c) 1 serving of yogurt, or (d) 2 servings of yogurt per 2,380 kcal/day.
On the 7th day of each diet, participants will complete a mixed-meal test at INAF, consuming a smoothie containing the same yogurt dose as during the preceding days. Plasma samples collected in the postprandial state will be used to profile over 20,000 metabolites. Using artificial intelligence-based approaches, potential biomarkers of yogurt intake will be identified. These candidates will then be filtered using standard statistical methods to assess dose- and time-responsiveness, robustness, and biological plausibility. Biomarkers that meet all criteria will be considered validated indicators of yogurt intake.
详细描述
The U.S. Food and Drug Administration recently deemed the scientific evidence sufficiently robust to approve a petition for a qualified health claim on yogurt and reduced type 2 diabetes (T2D) risk. In contrast, Health Canada has yet to approve a similar claim. The existing evidence is derived exclusively from prospective cohort studies relying on self-reported dietary questionnaires, which-despite being validated-are subject to random and systematic errors that may compromise evidence quality and hinder regulatory approval.
Biomarkers of food intake are increasingly recognized as valuable tools to enhance objectivity in nutritional epidemiology. Metabolomics, the comprehensive profiling of plasma metabolites, is considered the gold standard for identifying such biomarkers. In the context of dairy, a major milestone was the identification of a metabolomic signature of yogurt intake in a large Spanish cohort. This signature-comprising 27 metabolites (e.g., C14:0 sphingomyelin, derived from myristic acid)-was predictive of yogurt intake in an independent U.S. cohort and associated with lower T2D incidence in both populations. However, because this signature was derived from observational data, it lacked specificity for yogurt intake.
This project seeks to fill this critical gap by discovering specific biomarkers of yogurt intake and validating them against recognized criteria.
The investigators will conduct a randomized, crossover, dose-response feeding trial involving 16 generally healthy adult participants (8 females, 8 males). The trial will consist of 4 predetermined diets, each lasting 7 days and separated by a 1-week washout period. On the 7th day of each diet, participants will undergo a mixed-meal test at INAF to collect plasma samples in postprandial state. The 4 diets will be based on a dairy-free background diet reflecting high adherence to Canada's food guide, with the following additions:
- 125 g per 2,380 kcal per day of a soy-based pudding (i.e., yogurt-free diet);
- 90 g per 2,380 kcal per day of yogurt (i.e., 0.5 reference serving of yogurt per 2,380 kcal per day);
- 175 g per 2,380 kcal per day of yogurt (i.e., 1 reference serving of yogurt per 2,380 kcal per day);
- 350 g per 2,380 kcal per day of yogurt (i.e., 2 reference servings per 2,380 kcal per day).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants and the CRC cannot be blinded to diet allocation. However, the exact amount of yogurt (or soy-based pudding) in the diets will not be disclosed to participants. The four diets will be randomly labeled with letters (e.g., A=high yogurt, B=soy, C=low yogurt, D=moderate yogurt). This approach will minimize information bias for the completion of the R24W at the end of each intervention.
All analysis will be conducted by individuals blinded to the participants and the clinical research coordinator.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 18-70 years;
- •BMI: 18-40 kg/m²;
- •willingness to consume plain yogurt daily for 3 weeks;
- •for coffee/tea consumers, willingness to consume these beverages without added milk, cream or sugar for 4 weeks.
排除标准
- •lactose intolerance; blood donation within 2 months; severe chronic illness or ongoing treatment for conditions such as infections, autoimmune diseases, cancer, type 2 diabetes, Crohn's disease, celiac disease, hepatic or renal diseases;
- •history of severe cancer, cardiovascular disease or bariatric surgery;
- •unstable body weight for 3 months;
- •illicit drug use or alcoholism; tobacco/cannabis smoking/vaping (ensuring no day-to-day fluctuations and objective reporting of consumption is too complex);
- •allergies or aversions to components of the diets.
研究组 & 干预措施
125 g per 2,380 kcal per day of a soy-based pudding (i.e., yogurt-free diet);
The trial will consist of 4 predetermined diets, each lasting 7 days and separated by a 1-week washout period. The 4 diets will be based on a dairy-free background diet reflecting high adherence to Canada's food guide. In the yogurt-free control diet, the diet will include 125 g per 2,380 kcal per day of a soy-based pudding.
干预措施: Yogurt-free diet (Other)
90 g per 2,380 kcal per day of yogurt (0.5 reference serving of yogurt per 2,380 kcal per day)
The trial will consist of 4 predetermined diets, each lasting 7 days and separated by a 1-week washout period. The 4 diets will be based on a dairy-free background diet reflecting high adherence to Canada's food guide. In the low yogurt-diet, the diet will include 90 g per 2,380 kcal per day of yogurt (i.e., 0.5 reference serving of yogurt per 2,380 kcal per day).
干预措施: Low-yogurt diet (Other)
175 g per 2,380 kcal per day of yogurt (1 reference serving of yogurt per 2,380 kcal per day)
The trial will consist of 4 predetermined diets, each lasting 7 days and separated by a 1-week washout period. The 4 diets will be based on a dairy-free background diet reflecting high adherence to Canada's food guide. In the low yogurt-diet, the diet will include 175 g per 2,380 kcal per day of yogurt (1 reference serving of yogurt per 2,380 kcal per day).
干预措施: Moderate-yogurt diet (Other)
350 g per 2,380 kcal per day of yogurt (2 reference servings per 2,380 kcal per day).
The trial will consist of 4 predetermined diets, each lasting 7 days and separated by a 1-week washout period. The 4 diets will be based on a dairy-free background diet reflecting high adherence to Canada's food guide. In the low yogurt-diet, the diet will include 350 g per 2,380 kcal per day of yogurt (2 reference servings per 2,380 kcal per day).
干预措施: High-yogurt diet (Other)
结局指标
主要结局
Biomarker of yogurt intake
时间窗: Day 7
The trial is specifically designed to discover an validate biomarkers of yogurt intake. All plasma samples collected on day 7, before and during the test meal challenge will be used for data analysis to conduct discovery and validaiton of yogurt biomarkers.
次要结局
未报告次要终点
研究者
Jean-Philippe Drouin-Chartier
Professor
Laval University