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View on ClinicalTrials.gov

Testing Dairy yogurt against a placebo for body composition changes

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

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

Condition: Body Composition ChangesSponsor: Laval UniversityTarget enrollment: 75
  • 3 groups
  • One site, in Québec
  • Recruiting
INAF, Université Laval, Québec, Quebec

Interventions

  • Other intervention

    Dairy yogurt

    Dairy yogurt: two serving daily

  • Other intervention

    Plant based yogurt

    Plant based yogurt: two servings daily

  • Other intervention

    No yogurt

    No yogurt: zero serving yogurt

Canadian Sites (1)

1 of 1 recruiting

  • INAF, Université Laval

    Québec, Quebec

    Recruiting

Eligibility Criteria

See who this study is looking for15 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +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

  • Food allergies or intolerances (particularly dairy proteins and lactose)
  • Body weight change greater than 5 kg in the 3 months preceding the study
  • Currently dieting or following specific dietary patterns
  • 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
  • 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
  • Drug abuse
  • Previous or planned bariatric surgery
  • Hormone therapy
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to prevent a condition from developing.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 3 groups in this study.

Group A receives Dairy yogurt.

Registry label: A: Dairy yogurt

Group B, the comparison group, receives Plant based yogurt.

Registry label: B: Plant-based yogurt

Group C, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives No yogurt.

Registry label: C: No yogurt

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 40 years, with no upper limit given.

The study lists female participants only.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 75 people.

The study is currently expected to finish around December 2026.

The main measurement is taken over: At baselineBaselineYour starting measurements, taken before treatment begins.Read more → and at the end of the intervention (12 weeks).

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Change in bone health — measured over At baselineBaselineYour starting measurements, taken before treatment begins.Read more → and at the end of the intervention (12 weeks).

Change in bone health — measured over At baseline and at the end of the intrevention (12 weeks).

Change in gut microbiota — measured over At baseline and at the end of the intervention (12 weeks).

Change in gut microbiota function — measured over At baseline and at the end of the intervention (12 weeks).

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07578103 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Dairy yogurtDietary supplement

Dairy yogurt: two serving daily

From the trial registry — its own words, unedited.

What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.

Read the full explanation → · in clinical review

About Plant based yogurtDietary supplement

Plant based yogurt: two servings daily

From the trial registry — its own words, unedited.

What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.

Read the full explanation → · in clinical review

About No yogurtDietary supplement

No yogurt: zero serving yogurt

From the trial registry — its own words, unedited.

What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 40 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 40 years, with no upper limit given.

It lists female participants only.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: At baselineBaselineYour starting measurements, taken before treatment begins.Read more → and at the end of the intervention (12 weeks).

The study as a whole is currently expected to finish around 2026-12-31.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 75 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Québec, Quebec, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.