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

Primary Purpose

Muscle Atrophy

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nutritional supplementation during a 6 month resistance training program
Nutritional supplementation during a 6 month resistance training program
Nutritional supplementation during a 6 month resistance training program
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Muscle Atrophy

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of SaskatchewanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1% chocolate milk

Pea-based beverage

Placebo: Low protein plant-based beverage

Arm Description

250 ml of 1% chocolate milk consumed immediately after resistance training sessions + 250 ml of chocolate milk consumed 1 hour after resistance training sessions

250 ml of pea beverage consumed immediately after resistance training sessions + 250 ml of pea beverage consumed 1 hour after resistance training sessions

250 ml of placebo beverage consumed immediately after resistance training sessions + 250 ml of placebo beverage consumed 1 hour after resistance training sessions

Outcomes

Primary Outcome Measures

Change in lean tissue mass (kg)
Lean tissue mass measured by dual energy X-ray absorptiometry

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2022
Last Updated
November 25, 2022
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT05382026
Brief Title
Milk Versus a Pea-based Beverage for Bone and Muscle Health in Young Athletes
Official Title
Milk Versus a Pea-based Beverage for Increasing Muscle Mass and Bone Mineral Density During Resistance Training in Adolescent Boys and Girls
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Atrophy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1% chocolate milk
Arm Type
Experimental
Arm Description
250 ml of 1% chocolate milk consumed immediately after resistance training sessions + 250 ml of chocolate milk consumed 1 hour after resistance training sessions
Arm Title
Pea-based beverage
Arm Type
Active Comparator
Arm Description
250 ml of pea beverage consumed immediately after resistance training sessions + 250 ml of pea beverage consumed 1 hour after resistance training sessions
Arm Title
Placebo: Low protein plant-based beverage
Arm Type
Placebo Comparator
Arm Description
250 ml of placebo beverage consumed immediately after resistance training sessions + 250 ml of placebo beverage consumed 1 hour after resistance training sessions
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional supplementation during a 6 month resistance training program
Intervention Description
1% chocolate milk
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional supplementation during a 6 month resistance training program
Intervention Description
Pea-based beverage
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional supplementation during a 6 month resistance training program
Intervention Description
Maltodextrin placebo
Primary Outcome Measure Information:
Title
Change in lean tissue mass (kg)
Description
Lean tissue mass measured by dual energy X-ray absorptiometry
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in fat mass (kg)
Description
Fat mass measured by dual energy X-ray absorptiometry
Time Frame
6 months
Title
Change in lumbar spine bone mineral density (g/cm-squared)
Description
Lumbar spine bone mineral density measured by dual energy X-ray absorptiometry
Time Frame
6 months
Title
Change in hip bone mineral density (g/cm-squared)
Description
Hip bone mineral density measured by dual energy X-ray absorptiometry
Time Frame
6 months
Title
Change in bench press strength (kg)
Description
Bench press strength predicted from resistance lifted for 6-10 repetitions
Time Frame
6 months
Title
Change in squat strength (kg)
Description
Squat strength predicted from resistance lifted for 6-10 repetitions
Time Frame
6 months
Title
Change in cross-sectional moment of inertia at the hip (cm to the power of 4)
Description
Cross-sectional moment of inertia measured by dual energy X-ray absorptiometry
Time Frame
6 months
Title
Change in section modulus at the hip (cm to the power of 3)
Description
Section modulus measured by dual energy X-ray absorptiometry
Time Frame
6 months
Title
Change in cross-sectional area at the hip (cm-squared)
Description
Cross-sectional area measured by dual energy X-ray absorptiometry
Time Frame
6 months
Title
Change in cortical thickness at the hip (cm)
Description
Cortical thickness measured by dual energy X-ray absorptiometry
Time Frame
6 months
Title
Change in buckling ratio at the hip (no units)
Description
Buckling ratio measured by dual energy X-ray absorptiometry
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Chilibeck, PhD
Phone
306-966-1072
Email
phil.chilibeck@usask.ca
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N5B2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Chilibeck, PhD
Phone
306-966-1072
Email
phil.chilibeck@usask.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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

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