NCT07578103 Effect of Dairy Protein Yogourt vs Plant-based Yogourt on Body Weight, Body Composition, Bone Health and Gut Microbiota
| NCT ID | NCT07578103 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laval University |
| Condition | Body Composition Changes |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2023-11-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07578103 clinical trial?
This trial is open to female participants only, aged 40 Years or older, studying Body Composition Changes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07578103 currently recruiting?
Yes, NCT07578103 is actively recruiting participants. Contact the research team at julie.marois@fsaa.ulaval.ca for enrollment information.
Where is the NCT07578103 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT07578103 clinical trial?
NCT07578103 is sponsored by Laval University. The trial plans to enroll 75 participants.