NCT06138951

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

November 9, 2023

Last Update Submit

January 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Phenylalanine flux

    8 hours

  • Phenylalanine oxidation

    8 hours

Study Arms (3)

Nonexercised rested day

PLACEBO COMPARATOR

Athlete will not exercise on trial day.

Other: Endurance exercise

Recovery from 10KM run

EXPERIMENTAL

Athlete will run 10km on trial day.

Other: Endurance exercise

Recovery from 20KM run

EXPERIMENTAL

Athlete will run 20km on trial day.

Other: Endurance exercise

Interventions

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.

Nonexercised rested dayRecovery from 10KM runRecovery from 20KM run

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Centre for High Performance Sport at the University of Toronto

Toronto, Ontario, M5S2C9, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 18, 2023

Study Start

November 17, 2017

Primary Completion

August 15, 2018

Study Completion

January 1, 2019

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations