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

Sponsor
Applied Science & Performance Institute (Industry)
Overall Status
Completed
CT.gov ID
NCT04314596
Collaborator
Lonza Ltd. (Industry)
18
1
2
30
18.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cross Training Course
  • Dietary Supplement: Oceanix
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double-Blind, parallel, randomized, placebo-controlled trial.Double-Blind, parallel, randomized, placebo-controlled trial.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effects of Antioxidant Supplementation on Multiple Endurance Race Performance, Physiology, and Recovery.
Actual Study Start Date :
Jan 20, 2020
Actual Primary Completion Date :
Feb 12, 2020
Actual Study Completion Date :
Feb 19, 2020

Arms and Interventions

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.

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

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

Outcome Measures

Primary Outcome Measures

  1. Changes in muscle strength [Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.]

    Assessed by isometric mid-thigh pull.

  2. Changes in muscle power [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 [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) [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) [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 [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 Outcome Measures

  1. Creatine Kinase [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 [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 Outcome Measures

  1. VO2max [Baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Applied Science & Performance Institute Tampa Florida United States 33607

Sponsors and Collaborators

  • Applied Science & Performance Institute
  • Lonza Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Applied Science & Performance Institute
ClinicalTrials.gov Identifier:
NCT04314596
Other Study ID Numbers:
  • 1219
First Posted:
Mar 19, 2020
Last Update Posted:
Mar 19, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Applied Science & Performance Institute

Study Results

No Results Posted as of Mar 19, 2020