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.

Study Overview

• Status: Completed
• Conditions: Body Composition; Oxidative Stress; Muscle Strength; Muscle Damage; Resistance Training
• Intervention / Treatment: Dietary supplement: Oceanix; Other: Cross Training Course

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33607
      • Applied Science & Performance Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; 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; One day of a supervised, whole body, cross-training course that is meant to produce muscle damage and soreness.
Experimental: Experimental Group; 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.	Dietary supplement: Oceanix; Ingredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals.; Other: Cross Training Course; One day of a supervised, whole body, cross-training course that is meant to produce muscle damage and soreness.

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2max	Assessment of VO2max to determine fitness level and use as basis for randomization.	Baseline

Collaborators and Investigators

• Sponsor: Applied Science & Performance Institute
• Collaborators: Lonza Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): February 12, 2020
• Study Completion (Actual): February 19, 2020

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Antioxidants; Oxidative Stress; Muscle Strength; Resistance Training
• Other Study ID Numbers: 1219

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No