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

NCT ID: NCT04314596

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-20
• Study Completion Date: 2020-02-19

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.

Conditions

Oxidative Stress; Muscle Strength; Resistance Training; Body Composition; Muscle Damage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Cross Training Course

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Cross Training Course

Intervention Type: OTHER

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

Oceanix

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Cross Training Course

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

Intervention Type: OTHER

Oceanix

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lonza Ltd.

INDUSTRY

Sponsor Role: collaborator

Applied Science & Performance Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Applied Science & Performance Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

1219

Identifier Type: -

Identifier Source: org_study_id