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

NCT04314596 | Completed

• 1 other identifier: 1219
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

Oxidative Stress; Muscle Strength; Resistance Training; Antioxidants

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Creatine Kinase

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

• Cortisol

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

Other Outcomes (1)

• VO2max

  Baseline

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

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

Experimental Group

EXPERIMENTAL

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; Dietary Supplement: Oceanix

Interventions

Cross Training Course OTHER

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

Experimental Group; Placebo Group

Oceanix DIETARY_SUPPLEMENT

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

Experimental Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Applied Science & Performance Institute: lead
• Lonza Ltd.: collaborator

Study Sites (1)

Applied Science & Performance Institute

Tampa, Florida, 33607, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-Blind, parallel, randomized, placebo-controlled trial.

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: January 20, 2020
• Primary Completion: February 12, 2020
• Study Completion: February 19, 2020
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

US (1)