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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02478801
Other study ID # IAAO-E
Secondary ID
Status Completed
Phase Phase 0
First received June 18, 2015
Last updated June 15, 2016
Start date March 2015
Est. completion date May 2016

Study information

Verified date June 2016
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
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).

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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date May 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
amino acids intake
amino acids intakes will be varied at 0.2-2.8 g/kg/day

Locations

Country Name City State
n/a

Sponsors (2)

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

Outcome

Type Measure Description Time frame Safety issue
Primary 13CO2 (carbon dioxide) excretion (µmol/kg/h) 4 hours / study day No
Secondary [13C]phenylalanine oxidation (µmol/kg/h) 4 hours/study day No
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