- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02801344
The Impact of Protein Intake on Protein Metabolism During Intensified Training
The Impact of Protein Intake on Amino Acid and Protein Metabolism, and Performance During Intensified Training
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2C9
- Goldring Centre for High Performance Sport
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
test drink which contains low amount of amino acids (0.14 g/kg/day)
the diet containing 0.8 g protein /kg/day
|
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.
|
the diet containing 0.8 g protein /kg/day
test drink which contains moderate amount of amino acids (0.40 g/kg/day)
|
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.
|
the diet containing 0.8 g protein /kg/day
test drink which contains high amount of amino acids (1.03 g/kg/day)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 24h whole body protein balance
Time Frame: Difference between day 1 and day 4 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
|
Difference between day 1 and day 4 whole body protein balance
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline physical performance (5 km time trial) 5days after the beginning of training
Time Frame: 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.
|
5days after the beginning of training
|
change from baseline Physical performance (muscle strength) 5days after the beginning of training
Time Frame: 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.
|
5days after the beginning of training
|
change from baseline Physical Performance (muscle power) 5days after the beginning of training
Time Frame: 5days after the beginning of training
|
Peak lower body power will be measured by force platform after 4days-intensified training.
|
5days after the beginning of training
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Creatine Phosphate Kinase activity on day 5
Time Frame: 5days after the beginning of training
|
Muscle damage markers (blood Creatine Phosphate Kinase activity, IU/L) will be compared between the experimental arms 5days after the beginning of training
|
5days after the beginning of training
|
Myoglobin concentration on day 5
Time Frame: 5days after the beginning of training
|
Muscle damage markers (blood Mb Concentration, mg/mL) will be compared between the experimental arms 5days after the beginning of training
|
5days after the beginning of training
|
IL-6 concentration on day 5
Time Frame: 5days after the beginning of training
|
inflammatory markers (IL-6 concentration, pg/ml) will be compared between the experimental arms 5days after the beginning of training
|
5days after the beginning of training
|
CRP concentration on day 5
Time Frame: 5days after the beginning of training
|
inflammatory markers (CRP concentration, mg/L) will be compared between the experimental arms 5days after the beginning of training
|
5days after the beginning of training
|
amino acid concentration on day 5
Time Frame: 5days after the beginning of training
|
amino acid concentration (mmol/mL) will be compared between the experimental arms 5days after the beginning of training
|
5days after the beginning of training
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel Moore, Ph.D., Faculty of Kinesiology and Physical Education, University of Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PFE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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