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

Study Overview
=================
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.

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

Conditions
-----------------
Oxidative Stress, Muscle Strength, Resistance Training, Body Composition, Muscle Damage

Intervention / Treatment
-----------------
* Other: Cross Training Course
* Dietary Supplement: Oceanix


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-Blind, parallel, randomized, placebo-controlled trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Participants will engage in a one day, whole-body, cross-training course while consuming a visually identical placebo (25mg hydroxypropyl methylcellulose) 30 minutes prior to exercise on training days or with the first meal of the day on non-training days. Participants will then come in 24 and 48 hours post, cross-training course to be tested. | Other: Cross Training Course<br>* One day of a supervised, whole body, cross-training course that is meant to produce muscle damage and soreness.<br>|
| Experimental: Experimental Group<br>Participants will engage in a one day, whole-body, cross-training course while consuming the treatment condition (Oceanix™) 30 minutes prior to exercise on training days or with the first meal of the day on non-training days. Participants will then come in 24 and 48 hours post, cross-training course to be tested. | Other: Cross Training Course<br>* One day of a supervised, whole body, cross-training course that is meant to produce muscle damage and soreness.<br>Dietary Supplement: Oceanix<br>* Ingredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in muscle strength | Assessed by isometric mid-thigh pull. | Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course. | 
| Changes in muscle power | Assessed through ground reaction forces during countermovement and squat jumps on a force plate. | Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course. | 
| Changes in One(1) Mile Timed Run | Experimental outcome assessing how quickly a 1 mile run can be completed. | Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course. | 
| Changes in Perceived Recovery Status (PRS) | Assessed through a visual analog scale (modified Borg Scale) numbered 0 to 10 with visual descriptors. | Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course. | 
| Changes in Rating of Perceived Exertion (RPE) | Assessed through a visual analog scale numbered 0 to 10 with visual descriptors. | Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course. | 
| Changes in Perceived Soreness Scale | Assessed through a visual analog scale numbered 0 to 10 with visual descriptors. | Baseline, 1 Day of Cross-Training Course, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatine Kinase | Experimental outcome examining creatine kinase in fasted whole blood samples. This is biomarker an indirect measure of muscle damage. | Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course. | 
| Cortisol | Experimental outcome examining the concentration of cortisol in fasted saliva samples. | Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxidative Stress, Muscle Strength, Resistance Training, Antioxidants