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

NCT07578103 | Recruiting

• 1 other identifier: PROYO 2022-108
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gut Microbiota; Body Composition Changes; Body Weight Change; Metabolic Health; Bone Metabolism; Bone Health

Outcome Measures

Primary Outcomes (4)

• Change in bone health

  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

  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

  Assessment of global variation of the fecal microbiota

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

• Change in gut microbiota function

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

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

Secondary Outcomes (16)

• Change in body weight

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

• Change in anthropometric measures

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

• Change in anthropometric measure

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

• Change in body composition

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

• Change in skeletal muscle health

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

Study Arms (3)

Dairy yogurt

EXPERIMENTAL

Dietary Supplement: Dairy yogurt

Plant-based yogurt

ACTIVE COMPARATOR

Dietary Supplement: Plant based yogurt

No yogurt

PLACEBO COMPARATOR

Dietary Supplement: No yogurt

Interventions

Dairy yogurt DIETARY_SUPPLEMENT

Dairy yogurt: two serving daily

Dairy yogurt

Plant based yogurt DIETARY_SUPPLEMENT

Plant based yogurt: two servings daily

Plant-based yogurt

No yogurt DIETARY_SUPPLEMENT

No yogurt: zero serving yogurt

No yogurt

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

INAF, Université Laval

Québec, Quebec, G1V 0A6, Canada

RECRUITING

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Julie Marois, M.Sc.

CONTACT

1-418-656-5258; julie.marois@fsaa.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: November 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-04

Locations

CA (1)