Determining the Effect of Protein Quality on Post-exercise Anabolism in Active Youth

NCT ID: NCT05052827

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In adults, dairy protein is more effective than non-dairy sources at supporting recovery from exercise; however, it is not well understood if protein quality impacts short-term markers of growth in the same manner in active youth. Therefore, it is essential to understand whether different anabolic responses to varying protein quality persist in children, in order to maximize lean tissue accretion specifically during these periods of exponential growth. Thus, assessing the impact of protein quality on post-exercise protein synthesis and whole-body protein balance in active children would help provide valuable maturation-specific nutritional information. Moreover, these studies investigating the effects of protein quality in adults required the use of invasive techniques (i.e., muscle biopsies and indwelling catheters for blood draws) and are not suitable for vulnerable populations like children. As a result, the study of protein quality in children requires non-invasive alternative approaches and novel methods to advance our understanding of the nutritional best practices for active youth.

The overall objective of this investigation is to examine the impact of protein quality on post-exercise protein synthesis and acute markers of "growth" (i.e., net protein balance) in active youth (children and adolescents). Using the minimally invasive indicator amino acid oxidation (IAAO) methodology, we will determine the ability of milk, rice, and soy proteins to support whole-body protein synthesis and net-protein balance during recovery from an acute bout of sport specific moderate-to-vigorous physical activity.

The primary aim of the present study is to compare the ability of dairy and non-dairy alternatives (i.e., plant-based protein sources) to support post-exercise protein synthesis and net-protein balance in active, growing youth. The investigators hypothesize that the ingestion of milk protein concentrate (MPC) will result in a lower indicator amino acid oxidation (i.e., greatest protein synthesis) and higher net protein balance after exercise in both children and adolescents, compared to an isonitrogenous (i.e., equal protein amount) quantity of soy (SPI) and rice (RPI) protein isolate. This is predicated on the relative deficiency of branched-chain amino acids (BCAA) and other essential amino acids (EAA), specifically lysine and methionine, in RPI and SPI respectively, compared to MPC.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dietary Proteins

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Children

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.

Group Type ACTIVE_COMPARATOR

Milk Protein Concentrate

Intervention Type DIETARY_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

Rice Protein Isolate

Intervention Type DIETARY_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

Soy Protein Isolate

Intervention Type DIETARY_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

Adolescent Females

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.

Group Type ACTIVE_COMPARATOR

Milk Protein Concentrate

Intervention Type DIETARY_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

Rice Protein Isolate

Intervention Type DIETARY_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

Soy Protein Isolate

Intervention Type DIETARY_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

Adolescent Males

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.

Group Type ACTIVE_COMPARATOR

Milk Protein Concentrate

Intervention Type DIETARY_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

Rice Protein Isolate

Intervention Type DIETARY_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

Soy Protein Isolate

Intervention Type DIETARY_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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Milk Protein Concentrate

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

Intervention Type DIETARY_SUPPLEMENT

Rice Protein Isolate

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

Intervention Type DIETARY_SUPPLEMENT

Soy Protein Isolate

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MPC, Idaho Milk Products (Grade A) RPI, Axiom Foods - Organic Oryzatein Silk 90 MyProtein - Soy Protein Isolate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dairy Management Inc.

INDUSTRY

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel Moore

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Moore, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Hugo JW Fung, MSc

Role: STUDY_DIRECTOR

University of Toronto

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Goldring Centre for High Performance Sport

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

36378

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Anabolic Properties of Canola
NCT05664269 UNKNOWN NA