- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02478801
Protein Requirements in Endurance-trained Athlete (EP)
Evaluation of Protein Requirements in Male Endurance Athletes
Protein requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA).
Nutritional requirements for dietary amino acids in adults have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity.
Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than RDA based on nitrogen balance data.
Therefore, the purpose of this study is to measure the protein requirement in endurance trained adults using the IAAO technique.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy, male, endurance-trained participants who regularly more than 40 km/week
- Ability to perform the exercise stimulus (20 km run) on metabolic trial.
Exclusion Criteria:
- Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
- Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
- Regular tobacco use
- Illicit drug use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endurance trained
subjects will receive different levels of amino acids intakes varying from 0.2 to 2.8 g/kg/day.
|
amino acids intakes will be varied at 0.2-2.8
g/kg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
13CO2 (carbon dioxide) excretion (μmol/kg/h)
Time Frame: 4 hours / study day
|
4 hours / study day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
[13C]phenylalanine oxidation (μmol/kg/h)
Time Frame: 4 hours/study day
|
4 hours/study day
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IAAO-E
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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