Skip to main content
OpenTrials
Completed

NCT Number: NCT04314596

The Effects of Antioxidant Supplementation on Multiple Endurance Race Performance, Physiology, and Recovery.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oxidative Stress Body Composition Muscle Damage Muscle Strength Resistance Training

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Science & Performance Institute

Tampa, Florida, 33607, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cross Training Course

Other

One day of a supervised, whole body, cross-training course that is meant to produce muscle damage and soreness.

Oceanix

Dietary Supplement

Ingredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals.

Primary outcomes

  1. Changes in muscle strength

    Time frame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.

    Assessed by isometric mid-thigh pull.

  2. Changes in muscle power

    Time frame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.

    Assessed through ground reaction forces during countermovement and squat jumps on a force plate.

  3. Changes in One(1) Mile Timed Run

    Time frame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.

    Experimental outcome assessing how quickly a 1 mile run can be completed.

  4. Changes in Perceived Recovery Status (PRS)

    Time frame: Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.

    Assessed through a visual analog scale (modified Borg Scale) numbered 0 to 10 with visual descriptors.

  5. Changes in Rating of Perceived Exertion (RPE)

    Time frame: Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.

    Assessed through a visual analog scale numbered 0 to 10 with visual descriptors.

  6. Changes in Perceived Soreness Scale

    Time frame: Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.

    Assessed through a visual analog scale numbered 0 to 10 with visual descriptors.

Secondary outcomes

  1. Creatine Kinase

    Time frame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.

    Experimental outcome examining creatine kinase in fasted whole blood samples. This is biomarker an indirect measure of muscle damage.

  2. Cortisol

    Time frame: Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.

    Experimental outcome examining the concentration of cortisol in fasted saliva samples.

Other outcomes

  1. VO2max

    Time frame: Baseline

    Assessment of VO2max to determine fitness level and use as basis for randomization.

Sponsors and collaborators

Lead sponsor

Applied Science & Performance Institute

Industry

Collaborators

  • Lonza Ltd.

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2020
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.