Impact of Dairy Integration Into Canadian Food Guide on Gut Health

NCT07257913 | Recruiting

• 1 other identifier: 2024-569
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Milk consumption; Gut epithelial permeability; Inflammation; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• Gut epithelial permeability

  Post-intervention lactulose/mannitol ratio by LCMS, 0-5 hours after ingestion of the non-metabolizable sugar

  This outcome will be measured on the last day (day 13) of each intervention phase.

Secondary Outcomes (3)

• Gut inflammatory markers

  Samples will be collected on days 6 and 13 of each intervention phase.

• Perceived gut symptoms

  Gastrointestinal symptoms questionnaire is administered on days 0, 4 and 13.

• Whole gut transit time

  At days 1, 4 and 11.

Study Arms (3)

Milk

EXPERIMENTAL

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

Other: Milk; Other: Fermented milk; Other: Soy beverage

Fermented milk

EXPERIMENTAL

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

Other: Milk; Other: Fermented milk; Other: Soy beverage

Soy beverage

EXPERIMENTAL

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

Other: Milk; Other: Fermented milk; Other: Soy beverage

Interventions

Milk OTHER

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

Fermented milk; Milk; Soy beverage

Fermented milk OTHER

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

Fermented milk; Milk; Soy beverage

Soy beverage OTHER

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

Fermented milk; Milk; Soy beverage

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institute of Nutrition and Functional Foods (INAF)

Québec, Quebec, G1V 0A6, Canada

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Milk; Cultured Milk Products; Soy Milk

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Fermented Foods; Milk Substitutes; Soy Foods; Vegetable Products; Vegetables

Study Officials

• Alain Veilleux, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain Veilleux, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: December 2, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)