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

January 18, 2022 updated by: Daniel Moore, University of Toronto

Anabolic Potential of Dairy and Dairy Proteins for Active Children and Adolescents

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Dietary supplement: 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

Other Names:
  • MPC, Idaho Milk Products (Grade A)
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

Other Names:
  • RPI, Axiom Foods - Organic Oryzatein Silk 90
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

Other Names:
  • MyProtein - Soy Protein Isolate
Active Comparator: 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.
Dietary supplement: 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

Other Names:
  • MPC, Idaho Milk Products (Grade A)
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

Other Names:
  • RPI, Axiom Foods - Organic Oryzatein Silk 90
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

Other Names:
  • MyProtein - Soy Protein Isolate
Active Comparator: 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.
Dietary supplement: 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

Other Names:
  • MPC, Idaho Milk Products (Grade A)
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

Other Names:
  • RPI, Axiom Foods - Organic Oryzatein Silk 90
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

Other Names:
  • MyProtein - Soy Protein Isolate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
F13CO2
Time Frame: 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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Whole-Body Phenylalanine Kinetics
Time Frame: 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
Whole-Body Net Protein Balance
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dairy Management Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Moore, PhD, University of Toronto
  • Study Director: Hugo JW Fung, MSc, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 36378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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