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

Muscle Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05382026
• Other study ID #: 3228
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: November 2022
• Source: University of Saskatchewan
• Contact: Philip Chilibeck, PhD
• Phone: 306-966-1072
• Email: phil.chilibeck[@]usask.ca
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 114
• Est. completion date: August 31, 2023
• Est. primary completion date: June 30, 2023
• 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

Related Conditions & MeSH terms

• Muscle Atrophy
• Muscular Atrophy

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