NCT05052827

Brief Summary

Leucine-enriched proteins (e.g., dairy) are more effective than plant-based sources for supporting post-exercise rates of muscle protein synthesis in adults. However, the impact of protein quality on protein synthesis and acute markers of growth in active children are unknown. Using a randomized crossover design, the investigators will compare the effects of ingesting 0.35g/kg fat free mass (FFM) of either milk protein concentrate (MPC), rice protein isolate (RPI), or soy protein isolate (SPI) following a bout of variable intensity exercise with whole-body protein kinetics (i.e., oxidation, synthesis, breakdown, and net balance) determined by oral \[13C\]phenylalanine tracer methodology.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

September 13, 2021

Last Update Submit

November 9, 2023

Conditions

Keywords

protein qualitygrowthindicator amino acid oxidationchildrenadolescent

Outcome Measures

Primary Outcomes (1)

  • F13CO2

    Rate of 13CO2 excretion

    The rate of 13CO2 excretion based upon baseline (t=30 minutes) and isotopic steady state (t=360-420 minutes) 13CO2 enrichments in the breath and resting VCO2

Secondary Outcomes (1)

  • Whole-Body Phenylalanine Kinetics

    Whole-Body Net Protein Balance will be calculated based upon baseline (t=30 minutes) and isotopic steady state (t=360-420 minutes) 13CO2 enrichments in the breath and 1-[13C]phenylalanine enrichments in the urine

Study Arms (3)

Children

ACTIVE COMPARATOR

Participants underwent 3 metabolic trials in a randomized crossover fashion, where they were provided with an isonitrogenous quantities of either milk protein concentrate, soy protein isolate, and rice protein isolate following a standardized bout of variable intensity exercise.

Dietary Supplement: Milk Protein ConcentrateDietary Supplement: Rice Protein IsolateDietary Supplement: Soy Protein Isolate

Adolescent Females

ACTIVE COMPARATOR

Participants underwent 3 metabolic trials in a randomized crossover fashion, where they were provided with an isonitrogenous quantities of either milk protein concentrate, soy protein isolate, and rice protein isolate following a standardized bout of variable intensity exercise.

Dietary Supplement: Milk Protein ConcentrateDietary Supplement: Rice Protein IsolateDietary Supplement: Soy Protein Isolate

Adolescent Males

ACTIVE COMPARATOR

Participants underwent 3 metabolic trials in a randomized crossover fashion, where they were provided with an isonitrogenous quantities of either milk protein concentrate, soy protein isolate, and rice protein isolate following a standardized bout of variable intensity exercise.

Dietary Supplement: Milk Protein ConcentrateDietary Supplement: Rice Protein IsolateDietary Supplement: Soy Protein Isolate

Interventions

Milk Protein ConcentrateDIETARY_SUPPLEMENT

Protein provided at 0.35 g/kg fat free-mass. Macronutrient and Amino Acid Content provided below. Per 100 g protein powder: Calories (Cal): 363 Carbs (g): 5.60 Protein (g): 82.60 Fat (g): 1.12 Total BCAA (g): 15.67 Total EAA (g): 34.66 Total AA (g): 83.27

Also known as: MPC, Idaho Milk Products (Grade A)
Adolescent FemalesAdolescent MalesChildren
Rice Protein IsolateDIETARY_SUPPLEMENT

Protein provided at 0.35 g/kg fat free-mass. Macronutrient and Amino Acid Content provided below. Per 100 g protein powder: Calories (Cal): 394 Carbs (g): 6.50 Protein (g): 86.70 Fat (g): 2.39 Total BCAA (g): 14.98 Total EAA (g): 30.62 Total AA (g): 86.11

Also known as: RPI, Axiom Foods - Organic Oryzatein Silk 90
Adolescent FemalesAdolescent MalesChildren
Soy Protein IsolateDIETARY_SUPPLEMENT

Protein provided at 0.35 g/kg fat free-mass. Macronutrient and Amino Acid Content provided below. Per 100 g protein powder: Calories (Cal): 377 Carbs (g): 2.12 Protein (g): 88.8 Fat (g): 0.60 Total BCAA (g): 13.88 Total EAA (g): 31.74 Total AA (g): 89.39

Also known as: MyProtein - Soy Protein Isolate
Adolescent FemalesAdolescent MalesChildren

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy will be defined as screened by the PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone)
  • Regularly active, as defined by being in the top 20% of age specific scores on the iPAQ (the International Physical Activity Questionnaire)
  • Between the ages of 8 to 16 years
  • An age and sex-specific minimum of 75th percentile Beep Test level

You may not qualify if:

  • Inability to meet health and physical activity guidelines according to the PAR-Q+ and iPAQ
  • Inability to adhere to any of the protocol guidelines
  • Biological age outside of -0.5 to +1.5 years from PHV for adolescents, and \> -1 years from PHV for children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Centre for High Performance Sport

Toronto, Ontario, M5S 2C9, Canada

Location

MeSH Terms

Interventions

Soybean Proteins

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and Beverages

Study Officials

  • Daniel Moore, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR
  • Hugo JW Fung, MSc

    University of Toronto

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
As the study was a single-blind crossover design, the randomization of the protein type will be blinded to the participants only. The allocation concealment in relation to the liquid meal will be done by providing the same relative protein content (0.35 g/kg FFM) within the same volume of fluid, (8 ml/kg) to match the exercise-induced fluid loses, in opaque bottles. Additional carbohydrate (0.4g/kg) and artificial sweetener will be added to improve the organoleptic properties of the beverages.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Using a single-blind randomized counterbalanced crossover design, participants will complete three metabolic trials providing 0.35 g/kg FFM of either milk protein concentrate (MPC), rice protein isolate (RPI), or soy protein isolate (SPI) following a bout of variable intensity exercise.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 22, 2021

Study Start

September 1, 2021

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations