Identification of Objective Metabolomics-based Biomarkers of Yogurt Consumption

NCT07491887 | Not Yet Recruiting

• 1 other identifier: YOG
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diet

Keywords

yogurt; biomarker of food intake

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 7

Study Arms (4)

125 g per 2,380 kcal per day of a soy-based pudding (i.e., yogurt-free diet);

PLACEBO COMPARATOR

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.

Other: Yogurt-free diet

90 g per 2,380 kcal per day of yogurt (0.5 reference serving of yogurt per 2,380 kcal per day)

EXPERIMENTAL

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).

Other: Low-yogurt diet

175 g per 2,380 kcal per day of yogurt (1 reference serving of yogurt per 2,380 kcal per day)

EXPERIMENTAL

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).

Other: Moderate-yogurt diet

350 g per 2,380 kcal per day of yogurt (2 reference servings per 2,380 kcal per day).

EXPERIMENTAL

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).

Other: High-yogurt diet

Interventions

Yogurt-free diet OTHER

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.

125 g per 2,380 kcal per day of a soy-based pudding (i.e., yogurt-free diet);

Low-yogurt diet OTHER

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.

90 g per 2,380 kcal per day of yogurt (0.5 reference serving of yogurt per 2,380 kcal per day)

Moderate-yogurt diet OTHER

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.

175 g per 2,380 kcal per day of yogurt (1 reference serving of yogurt per 2,380 kcal per day)

High-yogurt diet OTHER

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.

350 g per 2,380 kcal per day of yogurt (2 reference servings per 2,380 kcal per day).

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institute on nutrition and functional foods, Laval University

Québec, Quebec, G1V0A?, Canada

Location

Study Officials

• Jean-Philippe Drouin-Chartier, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Philippe Drouin-Chartier, PhD

CONTACT

418-656-2131; jean-philipe.drouin-chartier@pha.ulaval.ca

Valérie Guay, MSc

CONTACT

418-656-2131; valerie.guay@fsaa.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 25, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: When study will be completed and published.
• Access Criteria: Access to the minimum dataset necessary to interpret, verify, and extend the research reported in this article will be made available upon request through a custom proprietary repository, in accordance with the conditions set by the local ethics review committee on data sharing. Data access requests should be directed to the principal investigator

Locations

CA (1)