Effect of Dairy Protein Yogourt vs Plant-based Yogourt on Body Weight, Body Composition, Bone Health and Gut Microbiota (PROYO)
5 mai 2026 mis à jour par: André Marette, Laval University
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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
75
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Julie Marois, M.Sc.
- Numéro de téléphone: 1-418-656-5258
- E-mail: julie.marois@fsaa.ulaval.ca
Lieux d'étude
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Quebec
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Québec, Quebec, Canada, G1V 0A6
- Recrutement
- INAF, Université Laval
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Contact:
- Julie Marois, M.Sc.
- Numéro de téléphone: 1-418-656-5258
- E-mail: julie.marois@fsaa.ulaval.ca
-
Chercheur principal:
- André Marette, PhD
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Dairy yogurt
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Dairy yogurt: two serving daily
|
|
Comparateur actif: Plant-based yogurt
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Plant based yogurt: two servings daily
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|
Comparateur placebo: No yogurt
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No yogurt: zero serving yogurt
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in bone health
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of bone mineral density using Dual X-ray Absorptiometry scan
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in bone health
Délai: 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)
|
At baseline and at the end of the intrevention (12 weeks)
|
|
Change in gut microbiota
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of global variation of the fecal microbiota
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in gut microbiota function
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of short-chain fatty acid (SCFA) in feces
|
At baseline and at the end of the intervention (12 weeks)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in body weight
Délai: At baseline and at the end of the intervention (12 weeks)
|
At baseline and at the end of the intervention (12 weeks)
|
|
|
Change in anthropometric measures
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of body mass index (BMI) using weight and height.
These two measurements will be combined to calculate BMI in kg/m2
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in anthropometric measure
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of waist circumference
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in body composition
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of changes in lean mass, fat mass and visceral fat mass (all in grams) using body composition by Dual X-ray Absorptiometry scan
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in skeletal muscle health
Délai: At baseline and at the end of the intervention (12 weeks)
|
muscle strength using handgrip strength tool (kg)
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in skeletal muscle health
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of physical performance using Timed Up and go Test
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in skeletal muscle health
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of functionnal capicity using 6-minute walk test)
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in Resting Metabolic Rate (RMR)
Délai: At baseline and at the end of the intervention (12 weeks)
|
Change in RMR using Calorimetry Device
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in Appetite and Satiety
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of leptin and ghrelin (both with same units of measurement)
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in Appetite and Satiety
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of appetite and satiety using visual analog scale
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in Eating behaviors
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of eating behaviors using Food Cravings Questionnaire (FCQ-T)
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in glycemia
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of fasting glucose concentration
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in insulinemia
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of fasting insulin concentration
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in lipid profile
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of triglycerides, LDL-cholesterol and HDL-cholesterol
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in blood pressure
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of systolic and diastolic blood pressure
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in chronic inflammation
Délai: At baseline and at the end of the intervention (12 weeks)
|
Assessment of plasma high sensitive C-Reactive Protein (hs-CRP) concentrations
|
At baseline and at the end of the intervention (12 weeks)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 novembre 2023
Achèvement primaire (Estimé)
30 juin 2026
Achèvement de l'étude (Estimé)
31 décembre 2026
Dates d'inscription aux études
Première soumission
5 mai 2026
Première soumission répondant aux critères de contrôle qualité
5 mai 2026
Première publication (Réel)
11 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 mai 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PROYO 2022-108
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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