- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06138951
Exercise Dose-response and Protein Requirements
January 4, 2024 updated by: Daniel Moore, University of Toronto
Dose Response Effect of Endurance Exercise on Protein Requirements of Endurance Athletes
Study will investigate the impact of training volume on protein metabolism to estimate the impact on daily protein requirements of endurance athletes.
Study Overview
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S2C9
- Goldring Centre for High Performance Sport at the University of Toronto
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Nonexercised rested day
Athlete will not exercise on trial day.
|
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.
|
|
Experimental: Recovery from 10KM run
Athlete will run 10km on trial day.
|
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.
|
|
Experimental: Recovery from 20KM run
Athlete will run 20km on trial day.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
8 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
8 hours
|
|
Phenylalanine oxidation
Time Frame: 8 hours
|
The oxidation of [13C]phenylalanine will be determined by correcting phenylalanine excretion by phenylalanine flux.
|
8 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 17, 2017
Primary Completion (Actual)
August 15, 2018
Study Completion (Actual)
January 1, 2019
Study Registration Dates
First Submitted
November 9, 2023
First Submitted That Met QC Criteria
November 15, 2023
First Posted (Actual)
November 18, 2023
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 4, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- DRE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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