Effect of Dairy Protein Yogourt vs Plant-based Yogourt on Body Weight, Body Composition, Bone Health and Gut Microbiota

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40+
SponsorLaval University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dairy yogurt

    Dietary supplement

    Dairy yogurt: two serving daily

  • Plant based yogurt

    Dietary supplement

    Plant based yogurt: two servings daily

  • No yogurt

    Dietary supplement

    No yogurt: zero serving yogurt

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Dairy yogurtExperimental treatment 1 intervention
Group B: Plant-based yogurtActive comparator 1 intervention
Group C: No yogurtPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in bone health

Assessment of bone mineral density using Dual X-ray Absorptiometry scan

Time frame
At baseline and at the end of the intervention (12 weeks)
2

Change in bone health

Assessment of bone turnover biomarkers (osteocalcin, c-telopeptide, Amino terminal propeptide of type 1 procollagen) (all in ng\\mL)

Time frame
At baseline and at the end of the intrevention (12 weeks)
3

Change in gut microbiota

Assessment of global variation of the fecal microbiota

Time frame
At baseline and at the end of the intervention (12 weeks)
4

Change in gut microbiota function

Assessment of short-chain fatty acid (SCFA) in feces

Time frame
At baseline and at the end of the intervention (12 weeks)

Secondary outcomes

1

Change in body weight

Time frame
At baseline and at the end of the intervention (12 weeks)
2

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

Time frame
At baseline and at the end of the intervention (12 weeks)
3

Change in anthropometric measure

Assessment of waist circumference

Time frame
At baseline and at the end of the intervention (12 weeks)
4

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

Time frame
At baseline and at the end of the intervention (12 weeks)

Other outcomes

Sponsors and contacts

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