Healthy Clinical Trial
Official title:
The Impact of Protein Intake on Amino Acid and Protein Metabolism, and Performance During Intensified Training
| 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 |
| Verified date | March 2019 |
| Source | University of Toronto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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.) |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Goldring Centre For High Performance Sport | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| University of Toronto | Ajinomoto Co., Inc. |
Canada,
| 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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