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

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314596
• Other study ID #: 1219
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: February 19, 2020

Study information

• Verified date: March 2020
• Source: Applied Science & Performance Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 19, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Applied Science & Performance Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Applied Science & Performance Institute	Lonza Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VO2max	Assessment of VO2max to determine fitness level and use as basis for randomization.	Baseline
Primary	Changes in muscle strength	Assessed by isometric mid-thigh pull.	Baseline, 24-Hour Post Cross-Training Course, 48-Hours Post Cross-Training Course.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.