NCT05827666

Brief Summary

The growth and development of lean body mass (i.e., muscle and bone) is instrumental to health and performance across the lifespan, especially in youth, as they actively experience growth. Thus, it is important to capitalize on physical activity and nutrition (especially dietary protein), to support the accretion of lean tissues. Eating a protein-rich meal or performing physical activity can stimulate protein synthesis, and when repeated over time, lean body mass accretion. There is currently an increasing market demand for non-dairy alternatives, due to multiple reasons including environmental, ethical, or taste preferences. However, it is important to understand how different beverages may support 'growth' (anabolism) of lean tissues after exercise. Research in adults has shown that dairy milk is superior to non-dairy milk beverages for supporting post-exercise recovery and muscle protein synthesis. However, the impact of dairy and non-dairy milk alternatives on recovery from exercise is not well understood in children. By understanding the milk beverage that best supports post-exercise recovery, the investigators can determine the optimal nutritional environment to facilitate the growth of lean tissues in the body.

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 Feb 2023

Shorter than P25 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

February 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

March 30, 2023

Last Update Submit

April 11, 2023

Conditions

Keywords

Nutrition in YouthGrowthActive youthProtein metabolismLean body massWhole food matrixProtein beverageChildrenAdolescentIndicator Amino Acid Oxidation

Outcome Measures

Primary Outcomes (1)

  • F13CO2

    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

    Duration of the metabolic trial (7 hours)

Secondary Outcomes (1)

  • Whole-Body Net Protein Balance

    Duration of the metabolic trial (7 hours)

Study Arms (3)

Children

ACTIVE COMPARATOR

Participants will undergo four metabolic trials in a randomized crossover design, where they will be provided with an isoenergetic (i.e., equal calories) amount of one of the following beverages upon completing a standardized bout of variably intensity exercise: 2% milk, almond 'milk,' soy 'milk,' or rice 'milk.'

Dietary Supplement: 2% milk beverageDietary Supplement: Almond milk alternative beverageDietary Supplement: Soy milk alternative beverageDietary Supplement: Rice milk alternative beverage

Adolescent females

ACTIVE COMPARATOR

Participants will undergo four metabolic trials in a randomized crossover design, where they will be provided with an isoenergetic (i.e., equal calories) amount of one of the following beverages upon completing a standardized bout of variably intensity exercise: 2% milk, almond 'milk,' soy 'milk,' or rice 'milk.'

Dietary Supplement: 2% milk beverageDietary Supplement: Almond milk alternative beverageDietary Supplement: Soy milk alternative beverageDietary Supplement: Rice milk alternative beverage

Adolescent males

ACTIVE COMPARATOR

Participants will undergo four metabolic trials in a randomized crossover design, where they will be provided with an isoenergetic (i.e., equal calories) amount of one of the following beverages upon completing a standardized bout of variably intensity exercise: 2% milk, almond 'milk,' soy 'milk,' or rice 'milk.'

Dietary Supplement: 2% milk beverageDietary Supplement: Almond milk alternative beverageDietary Supplement: Soy milk alternative beverageDietary Supplement: Rice milk alternative beverage

Interventions

2% milk beverageDIETARY_SUPPLEMENT

Protein provided at 0.3 g/kg fat-free mass. All other conditions (almond, soy and rice milk alternative beverages) will be matched to the same energy content (i.e., isoenergetic). Macronutrient content of beverage (per 100 g): Calories: 52 kcal; Fat: 2.25 g; Carbohydrates: 4.8 g; Protein: 3.3 g.

Also known as: Natrel 2% milk
Adolescent femalesAdolescent malesChildren

Matched to the same energy intake as 0.3 g/kg FFM of 2% milk. Macronutrient content of beverage (per 100 g): Calories: 24 kcal; Fat: 1.13 g; Carbohydrates: 3.1 g; Protein: 0.3 g.

Also known as: Silk Original Almond Beverage
Adolescent femalesAdolescent malesChildren

Matched to the same energy intake as 0.3 g/kg FFM of 2% milk. Macronutrient content of beverage (per 100 g): Calories: 39 kcal; Fat: 1.70 g; Carbohydrates: 3.0 g; Protein: 2.9 g.

Also known as: Silk Original Soy Beverage
Adolescent femalesAdolescent malesChildren

Matched to the same energy intake as 0.3 g/kg FFM of 2% milk. Macronutrient content of beverage (per 100 g): Calories: 49 kcal; Fat: 1.09 g; Carbohydrates: 9.8 g; Protein: 0.1 g.

Also known as: Rice Dream Milk Beverage
Adolescent femalesAdolescent malesChildren

Eligibility Criteria

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

You may qualify if:

  • Between the ages of 8-16 years
  • Children: \>-1 y age from peak height velocity\* (aPHV)
  • Adolescents: -0.5 to 1.5 aPHV
  • An age and sex-specific minimum of 75th percentile Beep Test level
  • Considered healthy based on responses to the PAR-Q+ and a medical history form \*NOTE: age from peak height velocity (aPHV): sitting/standing height

You may not qualify if:

  • Almond or soy allergy
  • Lactose intolerance
  • If enrolled as a child participant: biological age outside of \>-1 years from aPHV
  • If enrolled as an adolescent participant: biological age outside -0.5 to 1.5 aPHV
  • Inability to perform physical activity as determined by the PAR-Q+ and iPAQ
  • Inability to adhere to protocol guidelines (e.g., 2-day controlled diet)
  • Diagnosed medical condition under the care of a physician (e.g., type 1 diabetes)
  • Consuming any medications known to affect protein metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories)
  • Failure to complete all four metabolic trials within four months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Centre for High Performance and Sport

Toronto, Ontario, M5S 2C9, Canada

RECRUITING

MeSH Terms

Interventions

Milk

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Nicki Pourhashemi, BSc

    University of Toronto

    STUDY DIRECTOR

Central Study Contacts

Daniel R Moore, PhD

CONTACT

Hugo JW Fung, PhD (c)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
As the study is a single-blind crossover design, the randomization of the protein type will be blinded to the participants only. For each liquid meal, beverages will be provided in opaque bottles, and the caloric content of the beverages will be the same.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Using a single-blind randomized counterbalanced crossover design, participants will complete four metabolic trials providing one of the four isoenergetic (equal calories) beverages: 2% milk (MILK), soy 'milk,' (SOY), almond 'milk,' (ALMOND), or rice 'milk' (RICE) following a bout of variable-intensity exercise. The caloric content of the beverages is based on 0.3 g/kg FFM 2% milk.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 25, 2023

Study Start

February 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations