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
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
Treatments tested in this trial
- Yogurt-free diet
- Low-yogurt diet
- Moderate-yogurt diet
- High-yogurt diet
Treatment groups
16 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov