An interventional study of Milk and Fermented milk in Gut Epithelial Permeability, Gut Microbiota Composition and Diversity and Gut and Circulating Inflammatory Markers, sponsored by Laval University. Recruiting at 1 site in Canada. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Laval University · Not applicable, Interventional, and Basic science
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.
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:
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This study's planned enrollment of 20 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.
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Exclusion Criteria:
\- 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
\- 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
\- 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
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
Gut epithelial permeability
Post-intervention lactulose/mannitol ratio by LCMS, 0-5 hours after ingestion of the non-metabolizable sugar
Time frame: This outcome will be measured on the last day (day 13) of each intervention phase.
Gut inflammatory markers
Fecal calprotectin levels by ELISA
Time frame: Samples will be collected on days 6 and 13 of each intervention phase.
Perceived gut symptoms
Perception gastrointestinal symptoms questionnaires
Time frame: Gastrointestinal symptoms questionnaire is administered on days 0, 4 and 13.
Whole gut transit time
Whole gut transit time (h) by the Blue poop challenge
Time frame: At days 1, 4 and 11.
Plan to share: Yes — All IPD that underlie results in a publication
No publications or documents are linked to this record.
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Laval University