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CompletedNCT02801344Updated Mar 29, 2019

The Impact of Protein Intake on Protein Metabolism During Intensified Training

An interventional study of Normal and Moderate in Healthy, sponsored by University of Toronto. Completed at 1 site in Canada. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-29.

Sponsored by University of Toronto · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

Protein requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA).

Our recent study using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 30% higher than the recommended protein intake.

The present study will investigate the impact of protein sufficiency on protein metabolism and performance during intensified training periods as a means to further our understanding of the nutritional requirements for the endurance athlete.

02

Conditions studied

  • Healthy

Keywords

  • exercise
  • performance
  • recovery
  • muscle
  • protein
03

In context

Lead sponsor

University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy, male, endurance-trained participants who have run regularly more than 45 km or 4.5 hours/week
  • Participants who are categorized at least "very good" based on a study by Shvartz \& Reibold [40], in which peak rate of oxygen consumption(VO2 Peak) is used as an index. (i.e. the participants whose VO2peak is ≥57 ml/kg/min (18-24 y), ≥54 ml/kg/min (25-29 y), ≥52 ml/kg/min (30-34 y), ≥49 ml/kg/min (35-39 y), ≥47 ml/kg/min (40-44 y), ≥44 ml/kg/min (45-50 y) according to his age,
  • Participants who can cover 10 km in less than 60 min after the VO2peak test and 5 km Time trial on session 2.
  • Participants will be 18-50 years old.
  • Participants are willing to abide by the compliance rules of this study

Exclusion criteria

Exclusion Criteria:

  • Inability to meet health and physical activity guidelines according to the The Physical Activity Readiness Questionnaire for everyone.
  • Female
  • Inability to adhere to any of the compliance rules judged by principal investigator or medical doctor
  • Regular tobacco use
  • Illicit drug use (e.g. growth hormone, testosterone, etc.)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Normal protein intake

    participants will receive the controlled-diet containing 0.8 g protein /kg/day and the test drink containing 0.14 g protein/kg/d.

    Dietary Supplement: Normal · Other: Controlled-diet

  • Experimental
    Moderate protein intake

    participants will receive the controlled-diet containing 1.20 g protein /kg/day and the test drink containing 0.40 g protein/kg/d.

    Dietary Supplement: Moderate · Other: Controlled-diet

  • Experimental
    High protein intake

    participants will receive the controlled-diet containing 1.83 g protein /kg/day and the test drink containing 1.03 g protein/kg/d.

    Dietary Supplement: High · Other: Controlled-diet

Interventions

  • Dietary supplementNormal

    test drink which contains low amount of amino acids (0.14 g/kg/day)

  • Dietary supplementModerate

    test drink which contains moderate amount of amino acids (0.40 g/kg/day)

  • Dietary supplementHigh

    test drink which contains high amount of amino acids (1.03 g/kg/day)

  • OtherControlled-diet

    the diet containing 0.8 g protein /kg/day

06

What researchers measure

Primary outcomes

  1. Change in 24h whole body protein balance

    Protein balance (mg/kg/d; protein synthesis - protein breakdown) will be measured using \[15N\]Glycine method on day 1 and day 4 to determine the change over the intensified training period to compare between protein levels

    Time frame: Difference between day 1 and day 4 whole body protein balance

Secondary outcomes

  1. Change from baseline physical performance (5 km time trial) 5days after the beginning of training

    Before and after 4 days of intensified training period, Duration (seconds) for completing 5-km running on treadmill will be measured.

    Time frame: 5days after the beginning of training

  2. change from baseline Physical performance (muscle strength) 5days after the beginning of training

    Maximal strength will be assessed by a maximal isometric voluntary contraction (MVC), which will be tested for the knee-extensors using a custom-made knee-extension apparatus after 4 days intensified training.

    Time frame: 5days after the beginning of training

  3. change from baseline Physical Performance (muscle power) 5days after the beginning of training

    Peak lower body power will be measured by force platform after 4days-intensified training.

    Time frame: 5days after the beginning of training

Other outcomes

  1. Creatine Phosphate Kinase activity on day 5

    Muscle damage markers (blood Creatine Phosphate Kinase activity, IU/L) will be compared between the experimental arms 5days after the beginning of training

    Time frame: 5days after the beginning of training

  2. Myoglobin concentration on day 5

    Muscle damage markers (blood Mb Concentration, mg/mL) will be compared between the experimental arms 5days after the beginning of training

    Time frame: 5days after the beginning of training

  3. IL-6 concentration on day 5

    inflammatory markers (IL-6 concentration, pg/ml) will be compared between the experimental arms 5days after the beginning of training

    Time frame: 5days after the beginning of training

  4. CRP concentration on day 5

    inflammatory markers (CRP concentration, mg/L) will be compared between the experimental arms 5days after the beginning of training

    Time frame: 5days after the beginning of training

  5. amino acid concentration on day 5

    amino acid concentration (mmol/mL) will be compared between the experimental arms 5days after the beginning of training

    Time frame: 5days after the beginning of training

07

Study locations

1 site
  • Goldring Centre For High Performance Sport
    Toronto, Ontario M5S 2C9, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02801344
Lead sponsor
University of Toronto
Collaborators
Ajinomoto Co., Inc.
Responsible party
Daniel Moore (Associate professor, University of Toronto) — Principal investigator
First posted
Jun 15, 2016
Start date
May 2016
Primary completion
Sep 2017
Completion
Feb 2018
Last update
Mar 29, 2019

Study contacts

Daniel Moore, Ph.D.
principal investigator · Faculty of Kinesiology and Physical Education, University of Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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