Effect of Dairy Protein Yogourt vs Plant-based Yogourt on Body Weight, Body Composition, Bone Health and Gut Microbiota (PROYO)
5 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
75
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Julie Marois, M.Sc.
- Número de teléfono: 1-418-656-5258
- Correo electrónico: julie.marois@fsaa.ulaval.ca
Ubicaciones de estudio
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Quebec
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Québec, Quebec, Canadá, G1V 0A6
- Reclutamiento
- INAF, Université Laval
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Contacto:
- Julie Marois, M.Sc.
- Número de teléfono: 1-418-656-5258
- Correo electrónico: julie.marois@fsaa.ulaval.ca
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Investigador principal:
- André Marette, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Dairy yogurt
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Dairy yogurt: two serving daily
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Comparador activo: Plant-based yogurt
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Plant based yogurt: two servings daily
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Comparador de placebos: No yogurt
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No yogurt: zero serving yogurt
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in bone health
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
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Assessment of bone mineral density using Dual X-ray Absorptiometry scan
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At baseline and at the end of the intervention (12 weeks)
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Change in bone health
Periodo de tiempo: At baseline and at the end of the intrevention (12 weeks)
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Assessment of bone turnover biomarkers (osteocalcin, c-telopeptide, Amino terminal propeptide of type 1 procollagen) (all in ng\mL)
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At baseline and at the end of the intrevention (12 weeks)
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Change in gut microbiota
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
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Assessment of global variation of the fecal microbiota
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At baseline and at the end of the intervention (12 weeks)
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Change in gut microbiota function
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
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Assessment of short-chain fatty acid (SCFA) in feces
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At baseline and at the end of the intervention (12 weeks)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in body weight
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
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At baseline and at the end of the intervention (12 weeks)
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Change in anthropometric measures
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
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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)
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Change in anthropometric measure
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
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Assessment of waist circumference
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At baseline and at the end of the intervention (12 weeks)
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Change in body composition
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
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Assessment of changes in lean mass, fat mass and visceral fat mass (all in grams) using body composition by Dual X-ray Absorptiometry scan
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At baseline and at the end of the intervention (12 weeks)
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Change in skeletal muscle health
Periodo de tiempo: 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)
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Change in skeletal muscle health
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
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Assessment of physical performance using Timed Up and go Test
|
At baseline and at the end of the intervention (12 weeks)
|
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Change in skeletal muscle health
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
|
Assessment of functionnal capicity using 6-minute walk test)
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At baseline and at the end of the intervention (12 weeks)
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Change in Resting Metabolic Rate (RMR)
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
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Change in RMR using Calorimetry Device
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At baseline and at the end of the intervention (12 weeks)
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Change in Appetite and Satiety
Periodo de tiempo: 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)
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Change in Appetite and Satiety
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
|
Assessment of appetite and satiety using visual analog scale
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At baseline and at the end of the intervention (12 weeks)
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Change in Eating behaviors
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
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Assessment of eating behaviors using Food Cravings Questionnaire (FCQ-T)
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At baseline and at the end of the intervention (12 weeks)
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Change in glycemia
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
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Assessment of fasting glucose concentration
|
At baseline and at the end of the intervention (12 weeks)
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Change in insulinemia
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
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Assessment of fasting insulin concentration
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At baseline and at the end of the intervention (12 weeks)
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Change in lipid profile
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
|
Assessment of triglycerides, LDL-cholesterol and HDL-cholesterol
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At baseline and at the end of the intervention (12 weeks)
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Change in blood pressure
Periodo de tiempo: At baseline and at the end of the intervention (12 weeks)
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Assessment of systolic and diastolic blood pressure
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At baseline and at the end of the intervention (12 weeks)
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Change in chronic inflammation
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de noviembre de 2023
Finalización primaria (Estimado)
30 de junio de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
5 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de mayo de 2026
Publicado por primera vez (Actual)
11 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de mayo de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PROYO 2022-108
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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