Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT06138951
Eligibility Criteria:
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.)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06138951
Study Brief:
Protocol Section:
NCT06138951