Yogurt Consumption for Diet

(YOGBIO Trial)

Overseen By Valérie Guay, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: Lactose intolerance, Severe chronic illness, Cancer, others

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Jean-Philippe Drouin-Chartier, PhD

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

Inclusion Criteria

Willingness to consume plain yogurt daily for 3 weeks

I am willing to drink coffee or tea without milk, cream, or sugar for 4 weeks.

I am between 18 and 70 years old.

Exclusion Criteria

Allergies or aversions to components of the diets

Lactose intolerance

Blood donation within 2 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Diet Intervention

Participants undergo four 7-day diet periods with different yogurt servings, each separated by a 1-week washout period.

7 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the diet interventions.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Identification of Objective Metabolomics-based Biomarkers of Yogurt Consumption

How Is the Trial Designed?

Group I: 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

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).

Group II: 350 g per 2,380 kcal per day of yogurt (2 reference servings per 2,380 kcal per day). Experimental Treatment 1 Intervention

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).

Group III: 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

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).

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

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.

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+