ClinicalTrials.gg
RecruitingNCT07578103PROYOUpdated May 11, 2026

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

An interventional study of Dairy yogurt and Plant based yogurt in Body Composition Changes, Body Weight Change and Metabolic Health, sponsored by Laval University. Recruiting at 1 site in Canada. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Laval University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Registered 2 years 6 months after the study started (first participant enrolled Nov 2023, registered May 2026).
  • Started Nov 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
40 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

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

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03

In context

Body Weight Changes

231 studies on the registry are indexed under Body Weight Changes; 30 are open to participants now.

This study's planned enrollment of 75 is close to the median of 80 across 179 interventional studies indexed under Body Weight Changes.

Browse Body Weight Changes studies →

Lead sponsor

Laval University is the lead sponsor of 380 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women (absence of menstruation for at least 1 year and FSH > 40 IU/L)
  • between 27.0 and 39.9 kg/m²
  • Sedentary or moderately active

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Dairy yogurt

    Dietary Supplement: Dairy yogurt

  • Active comparator
    Plant-based yogurt

    Dietary Supplement: Plant based yogurt

  • Placebo comparator
    No yogurt

    Dietary Supplement: No yogurt

Interventions

  • Dietary supplementDairy yogurt

    Dairy yogurt: two serving daily

  • Dietary supplementPlant based yogurt

    Plant based yogurt: two servings daily

  • Dietary supplementNo yogurt

    No yogurt: zero serving yogurt

06

What researchers measure

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)

  5. Change in skeletal muscle health

    muscle strength using handgrip strength tool (kg)

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

  6. Change in skeletal muscle health

    Assessment of physical performance using Timed Up and go Test

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

  7. Change in skeletal muscle health

    Assessment of functionnal capicity using 6-minute walk test)

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

  8. Change in Resting Metabolic Rate (RMR)

    Change in RMR using Calorimetry Device

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

  9. Change in Appetite and Satiety

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

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

  10. Change in Appetite and Satiety

    Assessment of appetite and satiety using visual analog scale

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

  11. Change in Eating behaviors

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

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

  12. Change in glycemia

    Assessment of fasting glucose concentration

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

  13. Change in insulinemia

    Assessment of fasting insulin concentration

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

  14. Change in lipid profile

    Assessment of triglycerides, LDL-cholesterol and HDL-cholesterol

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

  15. Change in blood pressure

    Assessment of systolic and diastolic blood pressure

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

  16. Change in chronic inflammation

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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07578103
Lead sponsor
Laval University
Responsible party
André Marette (Professor, Laval University) — Principal investigator
First posted
May 11, 2026
Start date
Nov 1, 2023
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 11, 2026

Study contacts

Julie Marois, M.Sc.
Contact
julie.marois@fsaa.ulaval.ca
1-418-656-5258

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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