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Impact of Dairy Integration Into Canadian Food Guide on Gut Health

Impact of Dairy Integration Into Canadian Food Guide on Gut Health

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07257913
Acronym
GutMilk
Enrollment
20
Registered
2025-12-02
Start date
2025-10-06
Completion date
2026-08-31
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Detailed description

Single-blinded crossover RCT to test the impact of integrating dairy (i.e., milk and fermented milk) into the Canadian Food Guide (CFG) diet on gut health, in fully controlled dietary settings. The trial will include mid-age women and men with abdominal obesity and slightly deteriorated metabolic profile (n=20). The trial will feature 3 controlled-feeding phases (14 days), allocated in a random order and separated by free-uncontrolled feeding washout periods (14-28 days). Each dietary intervention phase will be initiated by a Run-in full-feeding period (4 days), to standardize participants' dietary intakes, and immediately followed by one of the 3 dietary interventions (9 days) reflecting adherence to the CFG recommendation (9 days, CFG-Diet) incorporating either soy beverages (Control), milk, or non-effervescent fermented milk. This approach was shown to be highly informative in deciphering the interaction between diet and the gut microbiota in previous work. It will be able to assess how integrating dairy (i.e., milk and fermented milk) into the Canadian Food Guide (CFG) diet promptly modulates gut health parameters (i.e. gut microbiota composition, inflammatory states, and gut permeability) in the context of obesity and metabolic complications, relative to a plant-based alternative. The fully controlled dietary setting of this study design will provide precise intakes of foods and bioactive nutrients, which will enable us to comprehensively assess the impact of dairies on gut health. The trial will include 10 women and 10 men with abdominal obesity and slightly deteriorated metabolic profile. Diet sequence allocation will be randomized with a sex-specific stratification. The study will be single-blinded, such as participants will not be informed of the precise nature of the diet sequence. TRIAL INTERVENTION PHASES (3 X 14 DAYS) During each intervention phases, all meals and foods will be provided to ensure optimal diet control. Each intervention phases will follow this sequence: * Day 0: Initiation of the run-in full-feeding period (4 days) to standardize participants' dietary intakes. * Day 4: Baseline sampling and data collection. * Day 4: Initiation of the CFG dietary intervention (10 days) incorporating either soy beverages (Control), milk, or non-effervescent fermented milk. * Day 6: Post-intervention (+2 days) sampling and data collection. * Day 13: Post-intervention (+9 days) sampling and data collection. End of the intervention phases.

Interventions

OTHERMilk

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

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

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

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Gut epithelial permeabilityThis outcome will be measured on the last day (day 13) of each intervention phase.Post-intervention lactulose/mannitol ratio by LCMS, 0-5 hours after ingestion of the non-metabolizable sugar

Secondary

MeasureTime frameDescription
Gut inflammatory markersSamples will be collected on days 6 and 13 of each intervention phase.Fecal calprotectin levels by ELISA
Perceived gut symptomsGastrointestinal symptoms questionnaire is administered on days 0, 4 and 13.Perception gastrointestinal symptoms questionnaires
Whole gut transit timeAt days 1, 4 and 11.Whole gut transit time (h) by the Blue poop challenge

Countries

Canada

Contacts

Primary ContactAlain Veilleux, PhD
alain.veilleux@fsaa.ulaval.ca418 656-2131

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026