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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05052827
Other study ID # 36378
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date March 2024

Study information

Verified date November 2023
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 24
Est. completion date March 2024
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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
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

Locations

Country Name City State
Canada Goldring Centre for High Performance Sport Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
University of Toronto Dairy Management Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Whole-Body Phenylalanine Kinetics 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
See also
  Status Clinical Trial Phase
Completed NCT00700804 - Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically? N/A
Completed NCT03785002 - Comparison of the Increment of Neuromuscular Parameters in Vegetarians and Non-vegetarians N/A
Recruiting NCT05827666 - The Effect of Dairy and Dairy-Free Alternative Beverages on Post-Exercise Anabolism in Active Youth N/A