The Long-term Effects of Oceanix™ on Resistance Training Adaptations

NCT ID: NCT04136821

Last Updated: 2020-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-01-31

Brief Summary

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This study will examine the effects of Oceanix™, an antioxidant supplement, on muscle performance, immune and endocrine function, recovery and safety in participants undergoing resistance training. Measures of muscle performance will include isometric testing in the bench-press and mid-thigh pull and ground reaction forces in the counter movement- and squat-jump. Markers of immune function will include salivary immunoglobulin A (IgA) as well as serum total antioxidant capacity (TAC) and superoxide dismutase (SOD) while endocrine function will be measured by salivary cortisol and testosterone. Recovery will be measure by plasma creatine kinase (CK) and perceptual measures will be assessed using a validated perceived recovery status (PRS) scale. Safety metrics will be indicated by a comprehensive metabolic panel (CMP), complete blood count (CBC), and urinalysis (UA). Additionally, the modified Borg Rating of Perceived Exertion (RPE) will be administered following each training session to grade physical exertion and monitor progression of the training protocol.

Detailed Description

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This study will examine the effects of Oceanix™, an antioxidant supplement, on muscle performance, immune and endocrine function, recovery and safety in participants undergoing resistance training. Measures of muscle performance will include isometric testing in the bench-press and mid-thigh pull and ground reaction forces in the counter movement- and squat-jump. Markers of immune function will include salivary immunoglobulin A (IgA) as well as serum total antioxidant capacity (TAC) and superoxide dismutase (SOD) while endocrine function will be measured by salivary cortisol and testosterone. Recovery will be measure by plasma creatine kinase (CK) and perceptual measures will be assessed using a validated perceived recovery status (PRS) scale. Safety metrics will be indicated by a comprehensive metabolic panel (CMP), complete blood count (CBC), and urinalysis (UA). Additionally, the modified Borg Rating of Perceived Exertion (RPE) will be administered following each training session to grade physical exertion and monitor progression of the training protocol.

This study will be a double blind parallel, randomized placebo-controlled trial. The investigators will request participation from 25 male and female participants (40-60 % mixture of each) ranging from 18 to 45 years old who are active (i.e. 30 minutes per week of vigorous activity classified as greater than 75 % of their HR max 3 days • week-1). The exclusion criteria will include having a BMI of 30 or more kg/m²; having cardiovascular, metabolic, or endocrine disease; undergone surgery that affects digestion and absorption, smoking, drinking 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. The investigators will also exclude individuals using antioxidant supplements, NSAIDS, or nutritional supplements known to stimulate recovery or muscle mass gains, heart disease, prescription medications, dietary supplements that enhance body strength, muscle, immune function, muscle recovery, or soreness. Additionally, individuals cannot have allergies for seaweeds or marine sources or any dietary supplements or take any psychiatric supplements or blood thinners.

Participants will be baselined and post-tested at week zero and again after 6 weeks of training, respectively. However, on weeks 2 and 5, participants will experience an overreaching phase to induce stress, and run through specific tests to gauge recovery at the end of those specific weeks. Variables collected at these time points are described below.

Primary variables:

* Muscle, fat mass, and bone density as indicated on DXA
* Upper body strength, velocity, and power on the bench press.
* Lower body strength and power on a dual force plate.
* Vertical jump performance on a dual force plate.
* Movement mechanics and stability using a combination of motion analysis and a dual force plate.

Secondary Variables

* CBC, CMP, Urinalysis
* Vital signs (blood pressure)
* Adverse Events Scale
* PRS and RPE scales

At the end of weeks 2 and 5 participants will be examined for their perceived recovery, soreness, serum markers of muscle damage (creatine kinase), and oxidative stress markers (SOD and Total Antioxidant Status). The rationale for the time points is to introduce extreme stressors in the early and late stages of the training protocol. Variables collected at these time points are described below.

Secondary variables

* Muscle damage (blood creatine kinase), soreness, and recovery.
* Immune function (IGA) , endocrine function (cortisol and testosterone), and oxidative stress (SOD and total antioxidant status).
* PRS scale

Conditions

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Oxidative Stress Muscle Strength Resistance Training Body Composition Muscle Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind, parallel, randomized, placebo-controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Participants will engage in a 6 week, whole-body, resistance training program 3-5 days per week will 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.

Group Type PLACEBO_COMPARATOR

Resistance Training

Intervention Type OTHER

6 weeks of supervised and programmed whole body resistance training, performed 3-5 times per week.

Oceanix™

Participants will engage in a 6 week, whole-body, resistance training program 3-5 days per week will consuming a the treatment condition (Oceanix™) 30 minutes prior to exercise on training days or with the first meal of the day on non-training days.

Group Type EXPERIMENTAL

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.

Resistance Training

Intervention Type OTHER

6 weeks of supervised and programmed whole body resistance training, performed 3-5 times per week.

Interventions

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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

Resistance Training

6 weeks of supervised and programmed whole body resistance training, performed 3-5 times per week.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Physically active males and females aged 18 to 45 years.
* Volunteers are deemed active if they engage in 30 minutes of vigorous activity, classified as greater than 75 % of their HR max, 3 days • week-1.

Exclusion Criteria

* \> BMI of 30 or more kg/m²
* Cardiovascular, metabolic, or endocrine disease
* Undergone surgery that affects digestion and absorption
* Smoking
* Drinking 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
* Individuals using antioxidant supplements, NSAIDS, or nutritional supplements known to stimulate recovery or muscle mass gains, heart disease, prescription medications, dietary supplements that enhance body strength, muscle, immune function, muscle recovery, or soreness
* Allergies for seaweeds or marine sources
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lonza Ltd.

INDUSTRY

Sponsor Role collaborator

Applied Science & Performance Institute

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Applied Science & Performance Institute

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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ASPI0519

Identifier Type: -

Identifier Source: org_study_id

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