Identification of Objective Metabolomics-based Biomarkers of Yogurt Consumption

ConditionDiet

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorLaval University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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);

Trial design

Design model

Crossover

Treatments tested in this trial

Yogurt-free diet
Other intervention
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.
Low-yogurt diet
Other intervention
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.
Moderate-yogurt diet
Other intervention
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.
High-yogurt diet
Other intervention
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.

Treatment groups

16 Participants

are divided into 4 treatment groups

Group A: 125 g per 2,380 kcal per day of a soy-based pudding (i.e., yogurt-free diet);Placebo comparator 1 intervention

Group B: 90 g per 2,380 kcal per day of yogurt (0.5 reference serving of yogurt per 2,380 kcal per day)Experimental treatment 1 intervention

Group C: 175 g per 2,380 kcal per day of yogurt (1 reference serving of yogurt per 2,380 kcal per day)Experimental treatment 1 intervention

Group D: 350 g per 2,380 kcal per day of yogurt (2 reference servings per 2,380 kcal per day).Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Biomarker of yogurt intake

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.

Time frame

Day 7

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laval University

Lead sponsor

Source ClinicalTrials.gov

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