Clinical trial NCT06727656: Exercise in Hypoxia and Nitrate Supplementation in Athletes: is the Whole Greater Than the Sum of Its Parts?
Official title: Exercise in Hypoxia and Nitrate Supplementation in Athletes: is the Whole Greater Than the Sum of Its Parts?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Lead sponsor: University of Trás-os-Montes and Alto Douro
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Determine the combined effect of training in hypoxia and nitrate supplementation on the performance and health of athletes at sea-level and altitude conditions.

Detailed description: Determine the combined effect of training in hypoxia and nitrate supplementation on the performance and health of athletes at sea-level and altitude conditions. It is hypothesized that the combined effect of these interventions will promote an additional performance and health improvement in this population at sea-level and altitude conditions, compared with the single effect.

Eligibility criteria: Inclusion Criteria:

* trained male subjects, regularly involved in competitive running, cycling and/ or triathlon events (4-5 times per week) in the past five years

Exclusion Criteria:

* smoking or other chronic issues
* using medication or dietary supplements in the last 3 months, or during the duration of the study
* being exposed to altitude (≥2000 m) in the last 3 months

Primary outcomes:
measure: Performance adaptations
timeFrame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
measure: Performance adaptations
timeFrame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
measure: Performance adaptations
timeFrame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
measure: Cardiovascular and neuromuscular adaptations
timeFrame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
measure: Cardiovascular and neuromuscular adaptations
timeFrame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
measure: Cardiovascular and neuromuscular adaptations
timeFrame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
measure: Skeletal muscle adaptations
timeFrame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
measure: Skeletal muscle adaptations
timeFrame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
measure: Haematological adaptations
timeFrame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
measure: Haematological adaptations
timeFrame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
measure: Oxidative stress and antioxidant markers adaptations
timeFrame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Secondary outcomes:
measure: Sleep and cardiac autonomic activity adaptations
timeFrame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
measure: Sleep and cardiac autonomic activity adaptations
timeFrame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
measure: Sleep and cardiac autonomic activity adaptations
timeFrame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
measure: Sleep and cardiac autonomic activity adaptations
timeFrame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
measure: Sleep and cardiac autonomic activity adaptations
timeFrame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Other outcomes:
Locations:
city: Vila Real
country: Portugal
facility: University of Trás-os-Montes e Alto-Douro
Study officials:
affiliation: University of Maia
name: Ana Sousa, PhD
role: PRINCIPAL_INVESTIGATOR
References: