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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02801344
Other study ID # PFE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date February 2018

Study information

Verified date March 2019
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date February 2018
Est. primary completion date September 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Normal
test drink which contains low amount of amino acids (0.14 g/kg/day)
Moderate
test drink which contains moderate amount of amino acids (0.40 g/kg/day)
High
test drink which contains high amount of amino acids (1.03 g/kg/day)
Other:
Controlled-diet
the diet containing 0.8 g protein /kg/day

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of Toronto Ajinomoto Co., Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 5days after the beginning of training
Other 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 5days after the beginning of training
Other 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 5days after the beginning of training
Other CRP concentration on day 5 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
Other amino acid concentration on day 5 amino acid concentration (mmol/mL) will be compared between the experimental arms 5days after the beginning of training 5days after the beginning of training
Primary 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 Difference between day 1 and day 4 whole body protein balance
Secondary 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. 5days after the beginning of training
Secondary 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. 5days after the beginning of training
Secondary 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. 5days after the beginning of training
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