Gut Epithelial PermeabilityGutMilkNCT07257913
Impact of Dairy Integration Into Canadian Food Guide on Gut Health
A study testing Milk, Fermented milk and Soy beverage in people with Gut Epithelial Permeability and Gut Microbiota Composition and Diversity, run by Laval University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Epithelial Permeability, Gut Microbiota Composition and Diversity, Gut and Circulating Inflammatory Markers
- What is being tested?
- Milk, Fermented milk and Soy beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 6 Oct 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- IMC < 45
- Waist circumference > 80 cm (Women) or 94 cm (men)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Institute of Nutrition and Functional Foods (INAF)
Québec, Quebec, G1V 0A6
Alain Veilleux, PhD, 418 656 2131 ext. 405108, alain.veilleux@fsaa.ulaval.ca
About this study
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.
Read the 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.
- Conditions
- Gut Epithelial Permeability, Gut Microbiota Composition and Diversity, Gut and Circulating Inflammatory Markers, Milk and Digestion
- Being tested
- Milk, Fermented milk, Soy beverage
- Keywords
- Milk consumption, Gut epithelial permeability, Inflammation, Gut microbiota
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilkOther
Consumption of 1 cup milk 3 times per day during 9 days alongside CFG diet
Fermented milkOther
Consumption of fermented milk 3 times per day during 9 days alongside CFG diet
Soy beverageOther
Consumption of a soy beverage 3 times per day during 9 days alongside CFG diet
| Study group | Role | What they receive |
|---|---|---|
| Milk | Experimental | - Consumption of milk 3 times per day during 9 days alongside CFG diet, following a 4 day control diet Receives: 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 Receives: 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 Receives: Other: Milk; Other: Fermented milk; Other: Soy beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut epithelial permeability
Post-intervention lactulose/mannitol ratio by LCMS, 0-5 hours after ingestion of the non-metabolizable sugar
Measured: This outcome will be measured on the last day (day 13) of each intervention phase.
Secondary outcomes (3)
Gut inflammatory markers
Fecal calprotectin levels by ELISA
Measured: Samples will be collected on days 6 and 13 of each intervention phase.
Perceived gut symptoms
Perception gastrointestinal symptoms questionnaires
Measured: 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
Measured: At days 1, 4 and 11.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start6 Oct 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut Epithelial PermeabilityStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alain Veilleux, Laval University
- Investigators
- Alain Veilleux, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257913
- Sponsor's protocol ID
- 2024-569
- Acronym
- GutMilk
- Status last verified
- Dec 2025
- First submitted
- 22 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dairy Integration Into Canadian Food Guide on Gut Health
- ClinicalTrials.gov ID
- NCT07257913
- Acronym / sponsor ID
- GutMilk / 2024-569
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Milk | Experimental | Other: Milk, Other: Fermented milk, Other: Soy beverage- Consumption of milk 3 times per day during 9 days alongside CFG diet, following a 4 day control diet |
| Fermented milk | Experimental | 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 |
| Soy beverage | Experimental | 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 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- IMC < 45
- Waist circumference > 80 cm (Women) or 94 cm (men)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MilkConsumption of 1 cup milk 3 times per day during 9 days alongside CFG diet | Other | Fermented milk, Milk, Soy beverage |
| Fermented milkConsumption of fermented milk 3 times per day during 9 days alongside CFG diet | Other | Fermented milk, Milk, Soy beverage |
| Soy beverageConsumption of a soy beverage 3 times per day during 9 days alongside CFG diet | Other | Fermented milk, Milk, Soy beverage |
Primary outcome
Gut epithelial permeability
Time frame: This 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
3 secondary outcomes
Gut inflammatory markers
Time frame: Samples will be collected on days 6 and 13 of each intervention phase.
Perceived gut symptoms
Time frame: Gastrointestinal symptoms questionnaire is administered on days 0, 4 and 13.
Whole gut transit time
Time frame: At days 1, 4 and 11.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alain Veilleux, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk, Fermented milk and Soy beverage in people with Gut Epithelial Permeability and Gut Microbiota Composition and Diversity, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alain Veilleux, PhD (418 656-2131 ext. 405108, alain.veilleux@fsaa.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut epithelial permeability (time frame: This outcome will be measured on the last day (day 13) of each intervention phase.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.