Muscle AtrophyNCT05382026
Milk Versus a Pea-based Beverage for Bone and Muscle Health in Young Athletes
A study testing Nutritional supplementation during a 6 month resistance training program in people with Muscle Atrophy, run by University of Saskatchewan at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Atrophy
- What is being tested?
- Nutritional supplementation during a 6 month resistance training program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- 24 May 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Currently participating in a resistance-training program 3 times per week
- Female participants must have reached menarche
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Atrophy
- Being tested
- Nutritional supplementation during a 6 month resistance training program
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supplementation during a 6 month resistance training programDietary supplement
1% chocolate milk
Nutritional supplementation during a 6 month resistance training programDietary supplement
Pea-based beverage
Nutritional supplementation during a 6 month resistance training programDietary supplement
Maltodextrin placebo
| Study group | Role | What they receive |
|---|---|---|
| 1% chocolate milk | Experimental | 250 ml of 1% chocolate milk consumed immediately after resistance training sessions + 250 ml of chocolate milk consumed 1 hour after resistance training sessions Receives: Dietary Supplement: Nutritional supplementation during a 6 month resistance training program |
| Pea-based beverage | Active comparator | 250 ml of pea beverage consumed immediately after resistance training sessions + 250 ml of pea beverage consumed 1 hour after resistance training sessions Receives: Dietary Supplement: Nutritional supplementation during a 6 month resistance training program |
| Placebo: Low protein plant-based beverage | Placebo comparator | 250 ml of placebo beverage consumed immediately after resistance training sessions + 250 ml of placebo beverage consumed 1 hour after resistance training sessions Receives: Dietary Supplement: Nutritional supplementation during a 6 month resistance training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lean tissue mass (kg)
Lean tissue mass measured by dual energy X-ray absorptiometry
Measured: 6 months
Secondary outcomes (10)
Change in fat mass (kg)
Fat mass measured by dual energy X-ray absorptiometry
Measured: 6 months
Change in lumbar spine bone mineral density (g/cm-squared)
Lumbar spine bone mineral density measured by dual energy X-ray absorptiometry
Measured: 6 months
Change in hip bone mineral density (g/cm-squared)
Hip bone mineral density measured by dual energy X-ray absorptiometry
Measured: 6 months
Change in bench press strength (kg)
Bench press strength predicted from resistance lifted for 6-10 repetitions
Measured: 6 months
Change in squat strength (kg)
Squat strength predicted from resistance lifted for 6-10 repetitions
Measured: 6 months
Change in cross-sectional moment of inertia at the hip (cm to the power of 4)
Cross-sectional moment of inertia measured by dual energy X-ray absorptiometry
Measured: 6 months
Change in section modulus at the hip (cm to the power of 3)
Section modulus measured by dual energy X-ray absorptiometry
Measured: 6 months
Change in cross-sectional area at the hip (cm-squared)
Cross-sectional area measured by dual energy X-ray absorptiometry
Measured: 6 months
Change in cortical thickness at the hip (cm)
Cortical thickness measured by dual energy X-ray absorptiometry
Measured: 6 months
Change in buckling ratio at the hip (no units)
Buckling ratio measured by dual energy X-ray absorptiometry
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start24 May 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phil Chilibeck, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382026
- Sponsor's protocol ID
- 3228
- Status last verified
- May 2024
- First submitted
- 14 May 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milk Versus a Pea-based Beverage for Increasing Muscle Mass and Bone Mineral Density During Resistance Training in Adolescent Boys and Girls
- ClinicalTrials.gov ID
- NCT05382026
- Acronym / sponsor ID
- 3228
- Conditions
- Muscle Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1% chocolate milk | Experimental | Dietary Supplement: Nutritional supplementation during a 6 month resistance training program250 ml of 1% chocolate milk consumed immediately after resistance training sessions + 250 ml of chocolate milk consumed 1 hour after resistance training sessions |
| Pea-based beverage | Active comparator | Dietary Supplement: Nutritional supplementation during a 6 month resistance training program250 ml of pea beverage consumed immediately after resistance training sessions + 250 ml of pea beverage consumed 1 hour after resistance training sessions |
| Placebo: Low protein plant-based beverage | Placebo comparator | Dietary Supplement: Nutritional supplementation during a 6 month resistance training program250 ml of placebo beverage consumed immediately after resistance training sessions + 250 ml of placebo beverage consumed 1 hour after resistance training sessions |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Currently participating in a resistance-training program 3 times per week
- Female participants must have reached menarche
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional supplementation during a 6 month resistance training program1% chocolate milk | Dietary supplement | 1% chocolate milk |
| Nutritional supplementation during a 6 month resistance training programPea-based beverage | Dietary supplement | Pea-based beverage |
| Nutritional supplementation during a 6 month resistance training programMaltodextrin placebo | Dietary supplement | Placebo: Low protein plant-based beverage |
Primary outcome
Change in lean tissue mass (kg)
Time frame: 6 months
Lean tissue mass measured by dual energy X-ray absorptiometry
10 secondary outcomes
Change in fat mass (kg)
Time frame: 6 months
Change in lumbar spine bone mineral density (g/cm-squared)
Time frame: 6 months
Change in hip bone mineral density (g/cm-squared)
Time frame: 6 months
Change in bench press strength (kg)
Time frame: 6 months
Change in squat strength (kg)
Time frame: 6 months
Change in cross-sectional moment of inertia at the hip (cm to the power of 4)
Time frame: 6 months
Change in section modulus at the hip (cm to the power of 3)
Time frame: 6 months
Change in cross-sectional area at the hip (cm-squared)
Time frame: 6 months
Change in cortical thickness at the hip (cm)
Time frame: 6 months
Change in buckling ratio at the hip (no units)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional supplementation during a 6 month resistance training program in people with Muscle Atrophy, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lean tissue mass (kg) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.