Dietary ProteinsPQSNCT05052827
Determining the Effect of Protein Quality on Post-exercise Anabolism in Active Youth
A study testing Milk Protein Concentrate, Rice Protein Isolate and Soy Protein Isolate in people with Dietary Proteins, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Proteins
- What is being tested?
- Milk Protein Concentrate, Rice Protein Isolate and Soy Protein Isolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2021to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Goldring Centre for High Performance Sport
Toronto, Ontario, M5S 2C9
About this study
Official title: 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.
Read the 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.
- Conditions
- Dietary Proteins
- Being tested
- Milk Protein Concentrate, Rice Protein Isolate, Soy Protein Isolate
- Keywords
- protein quality, growth, indicator amino acid oxidation, children, adolescent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk Protein ConcentrateDietary supplement
Also called MPC, Idaho Milk Products (Grade A)
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 IsolateDietary supplement
Also called RPI, Axiom Foods - Organic Oryzatein Silk 90
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 IsolateDietary supplement
Also called MyProtein - 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Milk Protein Concentrate; Dietary Supplement: Rice Protein Isolate; Dietary 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. Receives: Dietary Supplement: Milk Protein Concentrate; Dietary Supplement: Rice Protein Isolate; Dietary 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. Receives: Dietary Supplement: Milk Protein Concentrate; Dietary Supplement: Rice Protein Isolate; Dietary Supplement: Soy Protein Isolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
F13CO2
Rate of 13CO2 excretion
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Sep 2021
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ProteinsStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
- Investigators
- Daniel Moore, PhD, Principal investigator, University of TorontoHugo JW Fung, MSc, Study director, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052827
- Sponsor's protocol ID
- 36378
- Acronym
- PQS
- Status last verified
- Nov 2023
- First submitted
- 13 Sep 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anabolic Potential of Dairy and Dairy Proteins for Active Children and Adolescents
- ClinicalTrials.gov ID
- NCT05052827
- Acronym / sponsor ID
- PQS / 36378
- Conditions
- Dietary Proteins
- Keywords
- protein quality, growth, indicator amino acid oxidation, children, adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Children | Active comparator | Dietary Supplement: Milk Protein Concentrate, Dietary Supplement: Rice Protein Isolate, Dietary Supplement: Soy Protein IsolateParticipants 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. |
| Adolescent Females | Active comparator | Dietary Supplement: Milk Protein Concentrate, Dietary Supplement: Rice Protein Isolate, Dietary Supplement: Soy Protein IsolateParticipants 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. |
| Adolescent Males | Active comparator | Dietary Supplement: Milk Protein Concentrate, Dietary Supplement: Rice Protein Isolate, Dietary Supplement: Soy Protein IsolateParticipants 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. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk Protein ConcentrateAlso: MPC, Idaho Milk Products (Grade A)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 | Dietary supplement | Adolescent Females, Adolescent Males, Children |
| Rice Protein IsolateAlso: RPI, Axiom Foods - Organic Oryzatein Silk 90Protein 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 | Dietary supplement | Adolescent Females, Adolescent Males, Children |
| Soy Protein IsolateAlso: MyProtein - Soy Protein IsolateProtein 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 | Dietary supplement | Adolescent Females, Adolescent Males, Children |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Dietary Proteins
Recruiting
Acute Effects of Ketone Monoester Co-ingestion With Dietary Protein on Whole-body Phenylalanine Oxidation, Phenylalanine Retention, and Myofibrillar Protein Breakdown Following Resistance Exercise in Young Males.
Post-exercise Period, Ketosis
Not yet recruiting
Acute Effects of Ketone Monoester Co-Ingestion With Dietary Protein on Whole-Body Phenylalanine Oxidation, Phenylalanine Retention, and Myofibrillar Protein Breakdown Following Resistance Exercise in Older Males
Ketosis, Resistance Exercise
Recruiting
Suitability of a High-energy, Low-protein Formula (Renalive® LP)
CKD, Low Protein Dietary Intake
Recruiting
Investigating the Effects of Beef Consumption on Cognitive and Brain Health
Dietary Intervention, Dietary Proteins
Recruiting
Leucine Requirements During Pregnancy
Pregnancy, Dietary Analysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Moore, PhD principal investigator
University of Toronto
Hugo JW Fung, MSc study director
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk Protein Concentrate, Rice Protein Isolate and Soy Protein Isolate in people with Dietary Proteins, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.