Milk Versus a Pea-based Beverage for Bone and Muscle Health in Young Athletes

May 24, 2024 updated by: Phil Chilibeck, University of Saskatchewan

Milk Versus a Pea-based Beverage for Increasing Muscle Mass and Bone Mineral Density During Resistance Training in Adolescent Boys and Girls

Canada's Food Guide places an increased emphasis on plant-based proteins; however, Canadians who consume a plant-based diet may be compromised because of intake of lower-quality protein. Consumption of high-quality protein is important during growth and development, especially in highly active individuals. The study will compare milk (i.e. high quality protein) to a pea-based beverage (i.e. lower quality plant-based protein) in adolescent boys and girls who are engaged in resistance-training programs as part of their athletic training. One-hundred and fourteen adolescent boys and girls (12-17y of age) will be divided into groups that consume milk, a pea-beverage, or a carbohydrate (sugar) beverage after resistance training sessions performed three times per week for six months. It is predicted that the group consuming milk will have greater increases in muscle mass, strength, and bone density, and greater reductions in fat mass compared to the groups consuming a pea-based or carbohydrate beverages.

Study Overview

Status

Status

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

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

Milk protein is important especially for very active people and in the context of plant-based diets, which are lower in protein quality. The purpose of the study is to compare the effectiveness of milk supplementation to pea-beverage supplementation during resistance training programs for increasing lean tissue mass in adolescent boys and girls. Secondary and tertiary outcomes include fat mass, bone mineral density, and muscular strength. It is hypothesized that milk supplementation during resistance training will be more effective than plant-based proteins (i.e. pea-beverage) for increasing muscle mass, reducing fat mass, and improving bone mineral outcomes in adolescent boys and girls. One-hundred and fourteen boys and girls (aged 12-17y) who are currently enrolled in resistance training programs (3 times per week for 6 months) as part of their competitive athletic programs will be stratified by sex and maturity status before being randomized to three groups: 1) 1% chocolate milk supplementation; 2) pea-based beverage; 3) carbohydrate beverage (placebo control). Beverages will be consumed during recovery from each resistance training session (i.e. 250 ml immediately after training and 250 ml one hour later to optimize post-exercise protein synthesis) over the six-month intervention. It is anticipated that milk supplementation will be more effective than plant-based protein supplementation.

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 (Actual)

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.
112

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 Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N5B2
        • University of Saskatchewan

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

12 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Currently participating in a resistance-training program 3 times per week
  • Female participants must have reached menarche

Exclusion Criteria:

  • Have taken any nutritional supplement (e.g., protein, creatine, amino acids) within the past month
  • Currently taking anabolic steroids or oral corticosteroids
  • Allergies to dairy, almonds, cashews, or peas

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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.
Experimental: 1% chocolate milk
250 ml of 1% chocolate milk consumed immediately after resistance training sessions + 250 ml of chocolate milk consumed 1 hour after resistance training sessions
Dietary supplement: Nutritional supplementation during a 6 month resistance training program
1% chocolate milk
Dietary supplement: Nutritional supplementation during a 6 month resistance training program
Pea-based beverage
Dietary supplement: Nutritional supplementation during a 6 month resistance training program
Maltodextrin placebo
Active Comparator: Pea-based beverage
250 ml of pea beverage consumed immediately after resistance training sessions + 250 ml of pea beverage consumed 1 hour after resistance training sessions
Dietary supplement: Nutritional supplementation during a 6 month resistance training program
1% chocolate milk
Dietary supplement: Nutritional supplementation during a 6 month resistance training program
Pea-based beverage
Dietary supplement: Nutritional supplementation during a 6 month resistance training program
Maltodextrin placebo
Placebo Comparator: Placebo: Low protein plant-based beverage
250 ml of placebo beverage consumed immediately after resistance training sessions + 250 ml of placebo beverage consumed 1 hour after resistance training sessions
Dietary supplement: Nutritional supplementation during a 6 month resistance training program
1% chocolate milk
Dietary supplement: Nutritional supplementation during a 6 month resistance training program
Pea-based beverage
Dietary supplement: Nutritional supplementation during a 6 month resistance training program
Maltodextrin placebo

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
Change in lean tissue mass (kg)
Time Frame: 6 months
Lean tissue mass measured by dual energy X-ray absorptiometry
6 months

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
Change in fat mass (kg)
Time Frame: 6 months
Fat mass measured by dual energy X-ray absorptiometry
6 months
Change in lumbar spine bone mineral density (g/cm-squared)
Time Frame: 6 months
Lumbar spine bone mineral density measured by dual energy X-ray absorptiometry
6 months
Change in hip bone mineral density (g/cm-squared)
Time Frame: 6 months
Hip bone mineral density measured by dual energy X-ray absorptiometry
6 months
Change in bench press strength (kg)
Time Frame: 6 months
Bench press strength predicted from resistance lifted for 6-10 repetitions
6 months
Change in squat strength (kg)
Time Frame: 6 months
Squat strength predicted from resistance lifted for 6-10 repetitions
6 months
Change in cross-sectional moment of inertia at the hip (cm to the power of 4)
Time Frame: 6 months
Cross-sectional moment of inertia measured by dual energy X-ray absorptiometry
6 months
Change in section modulus at the hip (cm to the power of 3)
Time Frame: 6 months
Section modulus measured by dual energy X-ray absorptiometry
6 months
Change in cross-sectional area at the hip (cm-squared)
Time Frame: 6 months
Cross-sectional area measured by dual energy X-ray absorptiometry
6 months
Change in cortical thickness at the hip (cm)
Time Frame: 6 months
Cortical thickness measured by dual energy X-ray absorptiometry
6 months
Change in buckling ratio at the hip (no units)
Time Frame: 6 months
Buckling ratio measured by dual energy X-ray absorptiometry
6 months

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

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 (Actual)

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.
May 24, 2022

Primary Completion (Actual)

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.
January 31, 2024

Study Completion (Actual)

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.
January 31, 2024

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).
May 14, 2022

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.
May 14, 2022

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.
May 19, 2022

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.
May 29, 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.
May 24, 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.
May 1, 2024

More Information

Terms related to this study

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.
  • 3228

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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