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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06138951
Other study ID # DRE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 17, 2017
Est. completion date January 1, 2019

Study information

Verified date January 2024
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study will investigate the impact of training volume on protein metabolism to estimate the impact on daily protein requirements of endurance athletes.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date January 1, 2019
Est. primary completion date August 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: Healthy, male, endurance-trained participants who regularly run more than 40 km/week or perform endurance exercise for more than 4.5 hours/week - Participants who have a self-reported 5-km run time of =23 min - Participants who are categorized as at least "very good" based on a study by Shvartz & Reibold (Aviat Space Environ Med. 1990 Jan;61(1):3-11), in which VO2peak 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) - Ability to complete the 16-km familiarization run on Session 2 - Aged 18-40 years old Exclusion Criteria: - - Inability to meet health and physical activity guidelines according to the PAR-Q+. - Female: hormonal fluctuations associated with the menstrual cycle have been reported to alter protein metabolism during exercise and may influence specific amino acid requirements at rest; as such, the present study will test the effect of endurance exercise on protein requirements in males only to ensure a stable hormonal environment and to increase the homogeneity of the physiological response. (NOTE: we plan to test females in a future trial based off of the results obtained herein) - Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption) - Regular tobacco use - Illicit drug use (e.g. growth hormone, testosterone, etc.)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Endurance exercise
On the trial day before commencing the indicator amino acid oxidation metabolic trial, participants will either rest, perform a 10km run on a treadmill, or perform a 20km run on a treadmill.

Locations

Country Name City State
Canada Goldring Centre for High Performance Sport at the University of Toronto Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phenylalanine excretion Excretion of 13CO2 in the breath will be used to estimate the impact of exercise on daily protein requirements. This outcome will include the enrichment of 13CO2 in exhaled breath after the ingestion of [13C]phenylalanine tracer and the production of CO2 determined by indirect calorimetry at rest or after exercise. 8 hours
Secondary Phenylalanine flux The enrichment of [13C]phenylalanine in the urine will be used to estimate the flux of phenylalanine in the body at rest or after exercise. 8 hours
Secondary Phenylalanine oxidation The oxidation of [13C]phenylalanine will be determined by correcting phenylalanine excretion by phenylalanine flux. 8 hours
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