Recruiting

Milk, Fermented Milk, Soy

Sponsor:

Laval University

Code:

NCT07257913

Conditions

Gut Epithelial Permeability

Gut Microbiota Composition and Diversity

Gut and Circulating Inflammatory Markers

Milk and Digestion

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Accepted

Interventions

Milk

Fermented milk

Soy beverage

Study Details

Brief summary:

The primary objective is to investigate the impact of milk, fermented milk, and soy beverages, incorporated in a diet reflecting adherence to Canadian food guide recommendations on food choices on gut microbiota in middle-aged adults (45-65 years) with abdominal obesity and slightly deteriorated lipids and/or glucose profile. The study aims to discern whether the integration of soy beverages (control), milk, and fermented milk within the CFG diet contributes to distinct gut outcomes and alterations in gut health. We hypothesized that milk and fermented milk will further promote beneficial changes in gut health parameters including gut microbiota composition, trans-epithelial permeability, and inflammation, relative to soy beverages.

Conditions

Gut Epithelial Permeability

Gut Microbiota Composition and Diversity

Gut and Circulating Inflammatory Markers

Milk and Digestion

Study ID

NCT07257913

Start date

Oct 6, 2025

Status verified date

Dec, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • IMC < 45
  • Waist circumference > 80 cm (Women) or 94 cm (men)

Exclusion Criteria:

  • History of diabetes (types 1 and 2), CVD, enteropathy, immune diseases or bariatric surgery
  • Cancer (diagnostic and/or treatment) during the last 5 years
  • Antibiotic consumption during the last 3 months
  • Active smoking or cannabis consumption
  • Lactose intolerance or allergy, any allergies to foods given in the intervention phases
  • Irregular defecation patterns
  • Pregnancy/lactation
  • Inability to speak French

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Milk

\- Consumption of milk 3 times per day during 9 days alongside CFG diet, following a 4 day control diet

experimental: Fermented milk

\- Consumption of fermented milk 3 times per day during 9 days alongside CFG diet, following a 4 day control diet

experimental: Soy beverage

\- Consumption of a soy beverage 3 times per day during 9 days alongside CFG diet, following a 4 day control diet

Interventions

Milk

Consumption of 1 cup milk 3 times per day during 9 days alongside CFG diet

Fermented milk

Consumption of fermented milk 3 times per day during 9 days alongside CFG diet

Soy beverage

Consumption of a soy beverage 3 times per day during 9 days alongside CFG diet

Primary outcome measure

  • Gut epithelial permeability [ Time Frame: This outcome will be measured on the last day (day 13) of each intervention phase. ]

Central Contacts and Locations

Central contacts

Alain Veilleux, PhD

418 656-2131alain.veilleux@fsaa.ulaval.ca

Locations

Institute of Nutrition and Functional Foods (INAF)

Recruiting

Québec, Quebec, Canada, G1V 0A6

Contacts

Alain Veilleux, PhD

418 656 2131alain.veilleux@fsaa.ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Dec 2, 2025

Last verified

Dec, 2025

Keywords

  • Milk consumption
  • Gut epithelial permeability
  • Inflammation
  • Gut microbiota

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2025-12-02.