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OpenTrials
Completed

NCT Number: NCT06138951

Exercise Dose-response and Protein Requirements

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

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Goldring Centre for High Performance Sport at the University of Toronto

Toronto, Ontario, M5S2C9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Endurance Exercise

Other

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.

Primary outcomes

  1. Phenylalanine excretion

    Time frame: 8 hours

    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.

Secondary outcomes

  1. Phenylalanine flux

    Time frame: 8 hours

    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.

  2. Phenylalanine oxidation

    Time frame: 8 hours

    The oxidation of [13C]phenylalanine will be determined by correcting phenylalanine excretion by phenylalanine flux.

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

Dose Response Effect of Endurance Exercise on Protein Requirements of Endurance Athletes

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 18, 2023
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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