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NCT Number: NCT07578103

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

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.

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Key information

Conditions

Body Composition Changes Body Weight Body Weight Change Body Weight Changes Bone Health Bone Metabolism Gut Microbiota Metabolic Health Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

INAF, Université Laval

Québec, Quebec, G1V 0A6, Canada

Location status: Recruiting

Location contact

André Marette, PhD

PRINCIPAL_INVESTIGATOR

Julie Marois, M.Sc.

CONTACT

[email protected]

1-418-656-5258

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in bone health

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

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

  2. Change in bone health

    Time frame: 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)

  3. Change in gut microbiota

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

    Assessment of global variation of the fecal microbiota

  4. Change in gut microbiota function

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

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

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

    Time frame: 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

  3. Change in anthropometric measure

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

    Assessment of waist circumference

  4. Change in body composition

    Time frame: 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

  5. Change in skeletal muscle health

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

    muscle strength using handgrip strength tool (kg)

  6. Change in skeletal muscle health

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

    Assessment of physical performance using Timed Up and go Test

  7. Change in skeletal muscle health

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

    Assessment of functionnal capicity using 6-minute walk test)

  8. Change in Resting Metabolic Rate (RMR)

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

    Change in RMR using Calorimetry Device

  9. Change in Appetite and Satiety

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

    Assessment of leptin and ghrelin (both with same units of measurement)

  10. Change in Appetite and Satiety

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

    Assessment of appetite and satiety using visual analog scale

  11. Change in Eating behaviors

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

    Assessment of eating behaviors using Food Cravings Questionnaire (FCQ-T)

  12. Change in glycemia

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

    Assessment of fasting glucose concentration

  13. Change in insulinemia

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

    Assessment of fasting insulin concentration

  14. Change in lipid profile

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

    Assessment of triglycerides, LDL-cholesterol and HDL-cholesterol

  15. Change in blood pressure

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

    Assessment of systolic and diastolic blood pressure

  16. Change in chronic inflammation

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

    Assessment of plasma high sensitive C-Reactive Protein (hs-CRP) concentrations

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Marois, M.Sc.

CONTACT

[email protected]

1-418-656-5258

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

A New Focus on Protein and the Gut Microbiota to Explain Health Benefits of Dairy Foods

Acronym: PROYO

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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