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NOT YET RECRUITING
NCT07491887
NA

Identification of Objective Metabolomics-based Biomarkers of Yogurt Consumption

Sponsor: Laval University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2026-03-23

Completion Date

2026-06-30

Last Updated

2026-04-02

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

Yogurt-free diet

During 6 days, participants will receive a fully-controlled dairy-free background diet reflecting high adherence to Canada's food guide. The diet will be complemented by 125 g per 2,380 kcal per day of a soy-based pudding. On day 7, participants will undergo an acute mixed-meal test to inform on time-responsiveness of the yogurt biomarkers. After a 12-hour fast, participants will arrive at INAF at 7:30 AM. The test meal will consist of a breakfast smoothie containing the same soy-based pudding provided daily during the preceding days. Plasma samples will be collected at baseline (fasting) and 1, 2, 4, and 6 hours post-meal.

OTHER

Low-yogurt diet

During 6 days, participants will receive a fully-controlled dairy-free background diet reflecting high adherence to Canada's food guide. The diet will be complemented by 90 g per 2,380 kcal per day of yogurt (i.e., 0.5 reference serving of yogurt per 2,380 kcal per day). On day 7, participants will undergo an acute mixed-meal test to inform on time-responsiveness of the yogurt biomarkers. After a 12-hour fast, participants will arrive at INAF at 7:30 AM. The test meal will consist of a breakfast smoothie containing the same yogurt provided daily during the preceding days. Plasma samples will be collected at baseline (fasting) and 1, 2, 4, and 6 hours post-meal.

OTHER

Moderate-yogurt diet

During 6 days, participants will receive a fully-controlled dairy-free background diet reflecting high adherence to Canada's food guide. The diet will be complemented by 175 g per 2,380 kcal per day of yogurt (i.e., 1 reference serving of yogurt per 2,380 kcal per day). On day 7, participants will undergo an acute mixed-meal test to inform on time-responsiveness of the yogurt biomarkers. After a 12-hour fast, participants will arrive at INAF at 7:30 AM. The test meal will consist of a breakfast smoothie containing the same yogurt provided daily during the preceding days. Plasma samples will be collected at baseline (fasting) and 1, 2, 4, and 6 hours post-meal.

OTHER

High-yogurt diet

During 6 days, participants will receive a fully-controlled dairy-free background diet reflecting high adherence to Canada's food guide. The diet will be complemented by 350 g per 2,380 kcal per day of yogurt (i.e., 2 reference servings per 2,380 kcal per day). On day 7, participants will undergo an acute mixed-meal test to inform on time-responsiveness of the yogurt biomarkers. After a 12-hour fast, participants will arrive at INAF at 7:30 AM. The test meal will consist of a breakfast smoothie containing the same yogurt provided daily during the preceding days. Plasma samples will be collected at baseline (fasting) and 1, 2, 4, and 6 hours post-meal.

Locations (1)

Institute on nutrition and functional foods, Laval University

Québec, Quebec, Canada