- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05382026
Milk Versus a Pea-based Beverage for Bone and Muscle Health in Young Athletes
November 25, 2022 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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
114
Phase
- 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
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N5B2
- Recruiting
- 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
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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 |
Intervention / Treatment |
---|---|
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
|
1% chocolate milk
Pea-based beverage
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
|
1% chocolate milk
Pea-based beverage
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
|
1% chocolate milk
Pea-based beverage
Maltodextrin placebo
|
What is the study measuring?
Primary Outcome Measures
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
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
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)
May 24, 2022
Primary Completion (Anticipated)
June 30, 2023
Study Completion (Anticipated)
August 31, 2023
Study Registration Dates
First Submitted
May 14, 2022
First Submitted That Met QC Criteria
May 14, 2022
First Posted (Actual)
May 19, 2022
Study Record Updates
Last Update Posted (Actual)
November 30, 2022
Last Update Submitted That Met QC Criteria
November 25, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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