Clinical trial NCT04314596: The Effects of Antioxidant Supplementation on Multiple Endurance Race Performance, Physiology, and Recovery.
Official title: The Effects of Antioxidant Supplementation on Multiple Endurance Race Performance, Physiology, and Recovery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Muscle Strength
Resistance Training
Body Composition
Muscle Damage
Keywords: Oxidative Stress
Muscle Strength
Resistance Training
Antioxidants
Lead sponsor: Applied Science & Performance Institute
Sponsor class: INDUSTRY
Collaborators: name: Lonza Ltd.
First posted: 2020-03-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-Blind, parallel, randomized, placebo-controlled trial.
Primary purpose: TREATMENT

Brief summary: Thirty active male and female athletes will be recruited for the study. Subjects will be examined at baseline for VO2max performance. Subjects will then be stratified and randomly divided equally (50% - 50%) into an Oceanix (supplemental) or placebo condition such that baseline VO2max match. Once randomization, subjects will be baseline tested for multiple measures of muscle force capacity, muscle soreness, immune function, and endocrine function. Upon completion of baseline testing, subjects will all complete a one-day, cross-training course in Tampa, Florida. The training course is known to be extremely vigorous and causes significant muscle damage. Subjects will then be retested for muscle function at 24, and 48 hours following the course. At 24- and 48-hours subjects will be asked to repeat a simulated time trial race. In this way, we will measure repeated race performance, recovery from intense exercise, muscle damage from exercise, and immune function during multiple races.


Eligibility criteria: Inclusion Criteria:

* Males and females age 18 to 45 years old
* At least one year of cross training experience (i.e. 3 days/week)

Exclusion Criteria:

* BMI of 30 or more kg/m²
* Any allergies to fish, shellfish, algae, or seaweed are excluded from participation
* Have any cardiovascular, metabolic, or endocrine disease
* Undergone surgery that affects digestion and absorption
* Smoking
* Drink heavily (\> 7 and \> 14 drinks per week for women and men, respectively)
* Women who are pregnant or planning to be pregnant
* Taking medication to control blood pressure, lipids, and blood glucose
* Have taken or currently taking anabolic-androgenic steroids

Primary outcomes:
measure: Changes in muscle strength
timeFrame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
measure: Changes in muscle power
timeFrame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
measure: Changes in One(1) Mile Timed Run
timeFrame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
measure: Changes in Perceived Recovery Status (PRS)
timeFrame: Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
measure: Changes in Rating of Perceived Exertion (RPE)
timeFrame: Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
measure: Changes in Perceived Soreness Scale
timeFrame: Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Secondary outcomes:
measure: Creatine Kinase
timeFrame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
measure: Cortisol
timeFrame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Other outcomes:
measure: VO2max
timeFrame: Baseline
Locations:
city: Tampa
country: United States
facility: Applied Science & Performance Institute
state: Florida
Study officials:
References: