Body Composition ChangesPROYONCT07578103
Effect of Dairy Protein Yogourt vs Plant-based Yogourt on Body Weight, Body Composition, Bone Health and Gut Microbiota
A study testing Dairy yogurt, Plant based yogurt and No yogurt in people with Body Composition Changes and Body Weight Change, run by Laval University at 1 site in Canada.
Trial summary
The consumption of an adequate quantity of protein in the diet is essential to maintain a healthy body composition and functioning. It is also well established that all proteins are not equal regarding their ability to promote health benefits. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Composition Changes, Body Weight Change, Metabolic Health
- What is being tested?
- Dairy yogurt, Plant based yogurt and No yogurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2023to 31 Dec 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women (absence of menstruation for at least 1 year and FSH > 40 IU/L)
- BMI between 27.0 and 39.9 kg/m²
- Sedentary or moderately active
Who cannot join
- Body weight change greater than 5 kg in the 3 months preceding the study
- Currently dieting or following specific dietary patterns
- Previous or planned bariatric surgery
- Food allergies or intolerances (particularly dairy proteins and lactose)
- Serious or problematic health conditions (e.g., renal insufficiency, diabetes, Cushing's disease, Paget's disease, parathyroid disorders, inflammatory bowel disease, uncontrolled thyroid disease, etc.)
- Fracture within the past year
Show all 13Show fewer
- Hormone therapy
- Medications affecting bone metabolism (e.g., osteoporosis treatments, anti-estrogen therapy for breast cancer, epilepsy treatments)
- Antibiotic use within the 6 months preceding the study
- Use of probiotic supplements (capsules)
- More than two alcoholic drinks per day
- Smoking
- Drug abuse
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
INAF, Université Laval
Québec, Quebec, G1V 0A6
Julie Marois, M.Sc., 1-418-656-5258, julie.marois@fsaa.ulaval.ca
André Marette, PhD
About this study
Official title: A New Focus on Protein and the Gut Microbiota to Explain Health Benefits of Dairy Foods
The consumption of an adequate quantity of protein in the diet is essential to maintain a healthy body composition and functioning. It is also well established that all proteins are not equal regarding their ability to promote health benefits. Recently, we have innovated in that matter by showing that under the context of high intake of dietary fat, the dairy protein casein was more effective than a mix of proteins representative of a western diet to prevent body weight gain and insulin resistance. This was explained in part by modifications of the gut microbiota. This finding represents the main conceptual basis of the present research program that is aimed to determine the impact of dairy protein from yogurt compared to a plant-based equivalent on body composition indicators including muscle mass and bone mineral density, in relation to the profile of the gut microbiota, the production of newly discovered protein-derived metabolites, and markers of metabolic health. This program will include a human and an animal component requiring the testing of these variables before and after a standardized intervention. The human component will be a clinical study consisting of a 12-week diet-based weight loss intervention in postmenopausal overweight women being randomly assigned to one of the three following groups: yogurt, plant-based yogurt, or kept on diet without supplements. The animal experimentation will permit to causally determine the implication of the gut microbiota in the protein effects following transfer of the human bacteria to germ free mice and validate the benefits seen in humans. It is anticipated that these two complementary investigative approaches will allow a thorough documentation of the impact of fermented dairy protein on body composition and functioning, a better understanding of the underlying mechanisms, and the identification of new biomarkers to better appreciate related health benefits.
- Conditions
- Body Composition Changes, Body Weight Change, Metabolic Health, Bone Metabolism, Bone Health, Gut Microbiota
- Being tested
- Dairy yogurt, Plant based yogurt, No yogurt
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy yogurtDietary supplement
Dairy yogurt: two serving daily
Plant based yogurtDietary supplement
Plant based yogurt: two servings daily
No yogurtDietary supplement
No yogurt: zero serving yogurt
| Study group | Role | What they receive |
|---|---|---|
| Dairy yogurt | Experimental | Not described Receives: Dietary Supplement: Dairy yogurt |
| Plant-based yogurt | Active comparator | Not described Receives: Dietary Supplement: Plant based yogurt |
| No yogurt | Placebo comparator | Not described Receives: Dietary Supplement: No yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone health
Assessment of bone mineral density using Dual X-ray Absorptiometry scan
Measured: At baseline and at the end of the intervention (12 weeks)
Change in bone health
Assessment of bone turnover biomarkers (osteocalcin, c-telopeptide, Amino terminal propeptide of type 1 procollagen) (all in ng\mL)
Measured: At baseline and at the end of the intrevention (12 weeks)
Change in gut microbiota
Assessment of global variation of the fecal microbiota
Measured: At baseline and at the end of the intervention (12 weeks)
Change in gut microbiota function
Assessment of short-chain fatty acid (SCFA) in feces
Measured: At baseline and at the end of the intervention (12 weeks)
Secondary outcomes (16)
Change in body weight
Measured: At baseline and at the end of the intervention (12 weeks)
Change in anthropometric measures
Assessment of body mass index (BMI) using weight and height. These two measurements will be combined to calculate BMI in kg/m2
Measured: At baseline and at the end of the intervention (12 weeks)
Change in anthropometric measure
Assessment of waist circumference
Measured: At baseline and at the end of the intervention (12 weeks)
Change in body composition
Assessment of changes in lean mass, fat mass and visceral fat mass (all in grams) using body composition by Dual X-ray Absorptiometry scan
Measured: At baseline and at the end of the intervention (12 weeks)
Change in skeletal muscle health
muscle strength using handgrip strength tool (kg)
Measured: At baseline and at the end of the intervention (12 weeks)
Change in skeletal muscle health
Assessment of physical performance using Timed Up and go Test
Measured: At baseline and at the end of the intervention (12 weeks)
Change in skeletal muscle health
Assessment of functionnal capicity using 6-minute walk test)
Measured: At baseline and at the end of the intervention (12 weeks)
Change in Resting Metabolic Rate (RMR)
Change in RMR using Calorimetry Device
Measured: At baseline and at the end of the intervention (12 weeks)
Change in Appetite and Satiety
Assessment of leptin and ghrelin (both with same units of measurement)
Measured: At baseline and at the end of the intervention (12 weeks)
Change in Appetite and Satiety
Assessment of appetite and satiety using visual analog scale
Measured: At baseline and at the end of the intervention (12 weeks)
Change in Eating behaviors
Assessment of eating behaviors using Food Cravings Questionnaire (FCQ-T)
Measured: At baseline and at the end of the intervention (12 weeks)
Change in glycemia
Assessment of fasting glucose concentration
Measured: At baseline and at the end of the intervention (12 weeks)
Change in insulinemia
Assessment of fasting insulin concentration
Measured: At baseline and at the end of the intervention (12 weeks)
Change in lipid profile
Assessment of triglycerides, LDL-cholesterol and HDL-cholesterol
Measured: At baseline and at the end of the intervention (12 weeks)
Change in blood pressure
Assessment of systolic and diastolic blood pressure
Measured: At baseline and at the end of the intervention (12 weeks)
Change in chronic inflammation
Assessment of plasma high sensitive C-Reactive Protein (hs-CRP) concentrations
Measured: At baseline and at the end of the intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Nov 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Composition ChangesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Marette, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578103
- Sponsor's protocol ID
- PROYO 2022-108
- Acronym
- PROYO
- Status last verified
- Apr 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Focus on Protein and the Gut Microbiota to Explain Health Benefits of Dairy Foods
- ClinicalTrials.gov ID
- NCT07578103
- Acronym / sponsor ID
- PROYO / PROYO 2022-108
- Conditions
- Body Composition Changes, Body Weight Change, Metabolic Health, Bone Metabolism, Bone Health, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 May 2026 (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 consumption of an adequate quantity of protein in the diet is essential to maintain a healthy body composition and functioning. It is also well established that all proteins are not equal regarding their ability to promote health benefits. Recently, we have innovated in that matter by showing that under the context of high intake of dietary fat, the dairy protein casein was more effective than a mix of proteins representative of a western diet to prevent body weight gain and insulin resistance. This was explained in part by modifications of the gut microbiota. This finding represents the main conceptual basis of the present research program that is aimed to determine the impact of dairy protein from yogurt compared to a plant-based equivalent on body composition indicators including muscle mass and bone mineral density, in relation to the profile of the gut microbiota, the production of newly discovered protein-derived metabolites, and markers of metabolic health. This program will include a human and an animal component requiring the testing of these variables before and after a standardized intervention. The human component will be a clinical study consisting of a 12-week diet-based weight loss intervention in postmenopausal overweight women being randomly assigned to one of the three following groups: yogurt, plant-based yogurt, or kept on diet without supplements. The animal experimentation will permit to causally determine the implication of the gut microbiota in the protein effects following transfer of the human bacteria to germ free mice and validate the benefits seen in humans. It is anticipated that these two complementary investigative approaches will allow a thorough documentation of the impact of fermented dairy protein on body composition and functioning, a better understanding of the underlying mechanisms, and the identification of new biomarkers to better appreciate related health benefits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dairy yogurt | Experimental | Dietary Supplement: Dairy yogurt |
| Plant-based yogurt | Active comparator | Dietary Supplement: Plant based yogurt |
| No yogurt | Placebo comparator | Dietary Supplement: No yogurt |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women (absence of menstruation for at least 1 year and FSH > 40 IU/L)
- BMI between 27.0 and 39.9 kg/m²
- Sedentary or moderately active
Key exclusion criteria (13 listed)
- Body weight change greater than 5 kg in the 3 months preceding the study
- Currently dieting or following specific dietary patterns
- Previous or planned bariatric surgery
- Food allergies or intolerances (particularly dairy proteins and lactose)
- Serious or problematic health conditions (e.g., renal insufficiency, diabetes, Cushing's disease, Paget's disease, parathyroid disorders, inflammatory bowel disease, uncontrolled thyroid disease, etc.)
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 |
|---|---|---|
| Dairy yogurtDairy yogurt: two serving daily | Dietary supplement | Dairy yogurt |
| Plant based yogurtPlant based yogurt: two servings daily | Dietary supplement | Plant-based yogurt |
| No yogurtNo yogurt: zero serving yogurt | Dietary supplement | No yogurt |
Primary outcome
Change in bone health
Time frame: At baseline and at the end of the intervention (12 weeks)
Assessment of bone mineral density using Dual X-ray Absorptiometry scan
Change in bone health
Time frame: At baseline and at the end of the intrevention (12 weeks)
Assessment of bone turnover biomarkers (osteocalcin, c-telopeptide, Amino terminal propeptide of type 1 procollagen) (all in ng\mL)
Change in gut microbiota
Time frame: At baseline and at the end of the intervention (12 weeks)
Assessment of global variation of the fecal microbiota
Change in gut microbiota function
Time frame: At baseline and at the end of the intervention (12 weeks)
Assessment of short-chain fatty acid (SCFA) in feces
16 secondary outcomes
Change in body weight
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in anthropometric measures
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in anthropometric measure
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in body composition
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in skeletal muscle health
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in skeletal muscle health
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in skeletal muscle health
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in Resting Metabolic Rate (RMR)
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in Appetite and Satiety
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in Appetite and Satiety
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in Eating behaviors
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in glycemia
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in insulinemia
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in lipid profile
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in blood pressure
Time frame: At baseline and at the end of the intervention (12 weeks)
Change in chronic inflammation
Time frame: At baseline and at the end of the intervention (12 weeks)
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 11 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy yogurt, Plant based yogurt and No yogurt in people with Body Composition Changes and Body Weight Change, 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 3 inclusion and 13 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 11 May 2026. 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. Some participants in this study may receive a placebo. 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 Julie Marois, M.Sc. (1-418-656-5258, julie.marois@fsaa.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone health (time frame: At baseline and at the end of the intervention (12 weeks)). The study lists 4 primary outcomes in all. 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 11 May 2026.