Impact of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults

August 14, 2024 updated by: Hassanali Vatanparast, University of Saskatchewan

The Effects of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults: A Randomized Controlled Trial

Milk and dairy products contain significant amounts of nutrients that contribute to optimal health - nutrients like calcium, vitamin D, and high-quality protein. Fermented milk products or fermented dairy products are dairy foods that have been fermented with certain bacteria. Yogurt is a fermented dairy product containing millions of beneficial bacteria. In this study, the invesgitagtors will look at the effect of milk (a non-fermented dairy product) and yogurt (a fermented dairy product) supplementation on bone health and the amount of fat and muscle mass in Canadian young adults over a 24-month period. While dairy products contain significant amounts of nutrients, the scientific community does not know the impact of long-term supplementation of fermented (i.e., yogurt) or non-fermented (i.e., milk) dairy food on bone health and the amount of fat and muscle mass in young adults. To fill this knowledge gap, the investigators will recruit participants with low calcium intake and assign them to three different groups: 1) milk (intervention) group; 2) yogurt (intervention) group; and 3) control group. The investigators will ask the participants in the milk group to drink 1.5 servings (375 mL) of milk per day for 24 months. Participants in the yogurt group will consume 2 servings (350 g) of yogurt per day for 24 months. Those in the control group will continue their usual diets. Using a randomized controlled trial design, the investigators will measure bone health parameters, hormonal indices related to bone metabolism, body composition (e.g., muscle mass, fat mass), and the number and composition of bacteria living in the gastrointestinal (GI) tract. The hypothesis is that supplementation with yogurt will have more positive effects on bone health indices, particularly femoral neck BMD as the primary outcome, than milk in Canadian adults aged 19-30 years. The secondary hypothesis is that supplementation with yogurt, as a fermented milk product, will have a more beneficial effect than milk on body composition measures. The data will provide valuable information for developing targeted health initiatives and marketing strategies regarding the benefits of fermented and non-fermented dairy product consumption.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The overarching goal of this project is to determine the role of milk and yogurt supplementation on bone health and body composition in Canadian adults aged 19 to 30 years. Both the prevalence of obesity and osteoporosis among Canadians reflect a public health concern. According to data from 2018, 27% of Canadians aged 18 and older were classified as obese, and 36% were classified as overweight. Data from 2016 revealed a diagnosis of osteoporosis for 12% of Canadians. Consumption of milk and milk products play a role in bone homeostasis over the life course but most of the research has focused on children or older adults. Dairy product intake is associated with lower body weight or body fat. However, Canadian cross-sectional data shows a decline in the consumption of dairy products among all ages from 2004 to 2015. The overall impact of dairy consumption trends is reflected in the prevalence of calcium inadequacy among Canadians. Previous studies suggest that dairy products may positively influence bone homeostasis and body composition through various mechanisms involving key nutrients and the contribution of probiotics. Young adults are in a transitional period and thus at a critical point for developing healthy lifestyle habits that support optimal body composition and maintenance of peak bone mineral density. Further, as fermented milk products contain many beneficial nutrients, determining the specific role probiotics play is difficult to define. The research will build on previous studies with a specific focus on addressing current knowledge gaps on the health impacts of young adults and the comparison between milk and yogurt.

The specific objectives of the research are:

  1. To examine the effects of milk and yogurt supplementation on bone mineral density (BMD), bone mineral content (BMC), bone structure, and bone geometry of Canadian adults aged 19-30 years.
  2. To examine the effects of milk and yogurt supplementation on hormonal indices (parathyroid hormone, Insulin-like growth factor 1, 25-hydroxyvitamin D) related to bone metabolism in Canadian adults aged 19 to 30.
  3. To examine the effects of milk and yogurt supplementation on biochemical indices of bone turnover (Procollagen type 1 N-propeptide, Osteocalcin, Bone alkaline phosphatase, N-terminal telopeptide of type I collagen, C-terminal telopeptide of type 1 collagen) in Canadian adults aged 19-30.
  4. To examine the effects of milk and fermented milk product supplementation on body composition (bone-free lean tissue mass, total body fat mass, abdominal fat mass, percent total body fat) of Canadian adults aged 19 to 30.
  5. To examine the effects of milk and fermented milk product supplementation on gut microbiota of Canadian adults aged 19 to 30

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hassan Vatanparast, MD, PhD
  • Phone Number: 306-966-8866
  • Email: vatan.h@usask.ca

Study Contact Backup

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 5E5
        • Recruiting
        • University of Saskatchewan
        • Contact:
          • Hassan Vatanparast

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 19-30 years old
  • Dietary calcium intake below 1000mg/ day
  • living in the Saskatoon area (Saskatchewan, Canada)

Exclusion Criteria:

  • Calcium intake from both food and supplement above the estimated average requirement (EAR) for adults aged 19-30 years (>800 mg/day)
  • Total dairy intake of more than 1 serving per day
  • Body mass index greater than to 30 kg/m2
  • Medical history of metabolic bone, liver, endocrine, connective tissue, and respiratory diseases, thyroid disorders, or cancer
  • Diagnosed cases with secondary osteoporosis due to hypoparathyroidism
  • Hormonal disorders or disturbances
  • Taking medications known to influence bone mass and density (e.g., steroids, diuretics, heparin, and cancer drugs)
  • Cow's milk allergy
  • Pregnant or lactating women, or those planning to conceive during the duration of the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Habitual Diet (Control)
33 participants in this arm will continue to take their usual diet without any intervention.
Experimental: Habitual Diet + 1.5 Servings of Milk
Other: Habitual Diet + Milk
1.5 servings of milk [providing approx. 500 mg Ca/day] per day (either 1% fat milk, or 2% fat milk)
Experimental: Habitual Diet + 2 Servings of Yogurt
Other: Habitual Diet + Yogurt
2 servings of yogurt [providing approx. 500 mg Ca/day] per day (either 1% fat plain yogurt, 2% fat plain yogurt, 1% fat flavoured yogurt, 2% fat flavoured yogurt)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Femoral neck bone mineral density
Time Frame: Baseline, month 12, month 24
Measurement will be done via Dual Energy X-ray Absorptiometry.
Baseline, month 12, month 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bone mineral density (total hip, lumbar spine, whole body)
Time Frame: Baseline, month 12, month 24
Measurement will be done via Dual Energy X-ray Absorptiometry.
Baseline, month 12, month 24
Bone mineral content (total hip, femoral neck, lumbar spine, whole body)
Time Frame: Baseline, month 12, month 24
Measurement will be done via Dual Energy X-ray Absorptiometry.
Baseline, month 12, month 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bone structure
Time Frame: Baseline, month 12, month 24
Measurement via HR-pQCT scan at distal radius and tibia
Baseline, month 12, month 24
Bone geometry
Time Frame: Baseline, month 12, month 24
Measurement via HR-pQCT scan at distal radius and tibia
Baseline, month 12, month 24
Serum bone alkaline phosphatase (biochemical indices of bone turnover)
Time Frame: Baseline, month 12, month 24
Fasting blood sample will be collected from each participant between 8 a.m. and 10 a.m. after an overnight fast of 12 hours with no heavy exercise/workouts 48 hours prior to blood collection into 2 x 4ml serum separating tubes (SST) for the analysis of all serum measures.
Baseline, month 12, month 24
Serum osteocalcin (biochemical indices of bone turnover)
Time Frame: Baseline, month 12, month 24
Fasting blood sample will be collected from each participant between 8 a.m. and 10 a.m. after an overnight fast of 12 hours with no heavy exercise/workouts 48 hours prior to blood collection into 2 x 4ml serum separating tubes (SST) for the analysis of all serum measures.
Baseline, month 12, month 24
Serum procollagen type 1 N-propeptide (biochemical indices of bone turnover)
Time Frame: Baseline, month 12, month 24
Fasting blood sample will be collected from each participant between 8 a.m. and 10 a.m. after an overnight fast of 12 hours with no heavy exercise/workouts 48 hours prior to blood collection into 2 x 4ml serum separating tubes (SST) for the ananalysis of all serum measures.
Baseline, month 12, month 24
Serum N-terminal telopeptide of type 1 collagen (biochemical indices of bone turnover)
Time Frame: Baseline, month 12, month 24
Fasting blood sample will be collected from each participant between 8 a.m. and 10 a.m. after an overnight fast of 12 hours with no heavy exercise/workouts 48 hours prior to blood collection into 2 x 4ml serum separating tubes (SST) for the analysis of all serum measures.
Baseline, month 12, month 24
Serum C-terminal telopeptide of type 1 collagen (biochemical indices of bone turnover)
Time Frame: Baseline, month 12, month 24
Fasting blood sample will be collected from each participant between 8 a.m. and 10 a.m. after an overnight fast of 12 hours with no heavy exercise/workouts 48 hours prior to blood collection into 2 x 4ml serum separating tubes (SST) for the aanalysis of all serum measures.
Baseline, month 12, month 24
Serum PTH (hormonal indices related to bone metabolism)
Time Frame: Baseline, month 12, month 24
Fasting blood samples will be collected from each participant between 8 a.m. and 10 a.m. after an overnight fast of 12 hours with no heavy exercise/workouts 48 hours prior to blood collection for the analysis of all serum measures.
Baseline, month 12, month 24
Serum 25(OH)D (hormonal indices related to bone metabolism)
Time Frame: Baseline, month 12, month 24
Fasting blood samples will be collected from each participant between 8 a.m. and 10 a.m. after an overnight fast of 12 hours with no heavy exercise/workouts 48 hours prior to blood collection for the analysis of all serum measures.
Baseline, month 12, month 24
Serum IGF-1 (hormonal indices related to bone metabolism)
Time Frame: Baseline, month 12, month 24
Fasting blood samples will be collected from each participant between 8 a.m. and 10 a.m. after an overnight fast of 12 hours with no heavy exercise/workouts 48 hours prior to blood collection for the analysis of all serum measures.
Baseline, month 12, month 24
Saliva IGF-1 (hormonal indices related to bone metabolism)
Time Frame: Baseline, month 12, month 24
Saliva samples will be collected from each participant for analysis of salivary IGF-1 and comparison to serum IGF-1.
Baseline, month 12, month 24
Fat mass and lean mass
Time Frame: Baseline, month 12, month 24
Measurement via Dual Energy X-ray Absorptiometry.
Baseline, month 12, month 24
Height
Time Frame: Baseline, month 12, month 24
Height (cm) in standing position will be measured to the nearest 0.1 cm by a wall-mounted stadiometer.
Baseline, month 12, month 24
Weight
Time Frame: Baseline, month 12, month 24
For weight measurements, participants will be asked to wear light clothes and remove their shoes and jewelry and then stand on the SECA electronic scale to measure the weight to the nearest 0.01 kg.
Baseline, month 12, month 24
Gut microbiota via general lactobacillus and bifdobacterium
Time Frame: Baseline, month 12, month 24
Stool samples will be collected using DNAgenotek Omnigene sample collection kits and the total DNA of gut microbiomes from fecal material will be extracted using QIAamp PowerFecal Pro DNA Kit (Cat No. 51804), following manufacturer's instructions
Baseline, month 12, month 24
Dietary assessment
Time Frame: Baseline, month 6, month 12, month 18, month 24
Dietary intake will be assessed using serial 24-hour dietary recalls. Dietary data will be collected in person at baseline, 12 months, and 24 months and via telephone at 6 months and 18 months. The mean of three 24-h recalls at each time point will provide an estimation of the usual intake.
Baseline, month 6, month 12, month 18, month 24
Physical activity
Time Frame: Baseline, month 6, month 12, month 18, month 24
Physical activity will be captured using the Physical Activity Adult Questionnaire (PAAQ) to include transportation, recreational, and occupational or household physical activity in the last 7 days.
Baseline, month 6, month 12, month 18, month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Saskatchewan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dairy Farmers of Canada
Agriculture and Agri-Food Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hassan Vatanparast, MD, PhD, University of Saskatchewan
  • Principal Investigator: Phil Chilibeck, PhD, University of Saskatchewan
  • Principal Investigator: Sandra Clarke, Agriculture and Agri-Food Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 104993

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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