Effect of Dairy Protein Yogourt vs Plant-based Yogourt on Body Weight, Body Composition, Bone Hea… (NCT07578103) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Dairy Protein Yogourt vs Plant-based Yogourt on Body Weight, Body Composition, Bone Health and Gut Microbiota
Canada75 participantsStarted 2023-11-01
Plain-language 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.
Who can participate
Age range
40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares dairy protein yogurt to plant-based yogurt and is looking at effects on bone health and gut microbiota — given my current bone density and gut health status, is this the kind of study my doctor thinks could be relevant to where I am right now?
2Since this trial is listed as Phase NA, which often means it's a nutritional or lifestyle study rather than a drug trial, can my doctor explain what that means for how much is already known about the safety and risks of participating?
3The study is measuring changes in body composition, bone metabolism, and gut microbiota function — are there any baseline tests or health conditions I have that might affect how useful or appropriate it would be for me to take part?
4The trial involves regularly consuming a specific type of yogurt over a study period — can my doctor help me understand what the day-to-day commitment looks like and whether any dietary restrictions or monitoring would be required of me?
5Before considering this trial, are there established dietary recommendations or standard-of-care approaches for improving my bone health and gut microbiota that my doctor thinks I should try first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in bone health
Timeframe: At baseline and at the end of the intervention (12 weeks)
2
Change in bone health
Timeframe: At baseline and at the end of the intrevention (12 weeks)
3
Change in gut microbiota
Timeframe: At baseline and at the end of the intervention (12 weeks)
4
Change in gut microbiota function
Timeframe: At baseline and at the end of the intervention (12 weeks)