NCT05382026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

May 24, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

1.7 years

First QC Date

May 14, 2022

Last Update Submit

May 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in lean tissue mass (kg)

    Lean tissue mass measured by dual energy X-ray absorptiometry

    6 months

Secondary Outcomes (10)

  • Change in fat mass (kg)

    6 months

  • Change in lumbar spine bone mineral density (g/cm-squared)

    6 months

  • Change in hip bone mineral density (g/cm-squared)

    6 months

  • Change in bench press strength (kg)

    6 months

  • Change in squat strength (kg)

    6 months

  • +5 more secondary outcomes

Study Arms (3)

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

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

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

Dietary Supplement: Nutritional supplementation during a 6 month resistance training program

Interventions

1% chocolate milk

1% chocolate milk

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Currently participating in a resistance-training program 3 times per week
  • Female participants must have reached menarche

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N5B2, Canada

Location

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2022

First Posted

May 19, 2022

Study Start

May 24, 2022

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations