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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05382026
Other study ID # 3228
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 24, 2022
Est. completion date January 31, 2024

Study information

Verified date May 2024
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date January 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Nutritional supplementation during a 6 month resistance training program
1% chocolate milk
Nutritional supplementation during a 6 month resistance training program
Pea-based beverage
Nutritional supplementation during a 6 month resistance training program
Maltodextrin placebo

Locations

Country Name City State
Canada University of Saskatchewan Saskatoon Saskatchewan

Sponsors (1)

Lead Sponsor Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

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