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The Short Term Effects of Oceanix Supplementation on Recovery

NCT ID: NCT04315077

Last Updated: 2020-11-19

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2019-11-25

Brief Summary

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The purpose of this study will be to examine the effects of Oceanix supplementation on isometric mid-thigh pull force kinetics and salivary immunoglobulin A (indice of immune function) following a one-week intense resistance training protocol. The study will be carried out in a randomized, double-blind, placebo-controlled, parallel manner. Subjects will be stratified into quartiles based on peak force achieved in the isometric mid-thigh pull assessment during screen and prior to baseline testing. Subjects from each quartile will be randomly divided by into treatment and or placebo conditions.

Following randomization, subjects will be baseline tested on isometric mid-thigh pull and salivary immunoglobulin A. Following baseline testing, subject will be given their respective supplement conditions and will be instructed to consume one serving (25mg) a day for 21 consecutive days. For days 1 through 14 subjects will be asked to refrain from resistance training. Subjects will undergo a five day intense resistance training protocol will on day 15 to day 19. Subjects will complete follow-up testing in a manner identical to baseline on day 20 and 21 (24- and 48-hours post completion of the training protocol).

Detailed Description

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The purpose of this study will be to examine the effects of Oceanix supplementation on isometric mid-thigh pull force kinetics and salivary immunoglobulin A (indice of immune function) following a one-week intense resistance training protocol. The study will be carried out in a randomized, double-blind, placebo-controlled, parallel manner. Subjects will be stratified into quartiles based on peak force achieved in the isometric mid-thigh pull assessment during screen and prior to baseline testing. Subjects from each quartile will be randomly divided by into treatment and or placebo conditions. Supplement conditions will be provided in visually identical capsules and containers. Supplement compliance will be determined via supplement logs and collection of supplement containers on day 21. Subjects will be instructed to refrain from consuming other nutritional supplements for the duration of the study.

Following randomization, subjects will be baseline tested on isometric mid-thigh pull and salivary immunoglobulin A. Following baseline testing, subject will be given their respective supplement conditions and will be instructed to consume one serving (25mg) a day for 21 consecutive days. For days 1 through 14 subjects will be instructed to consume their condition with their first meal of the day, and they will asked to refrain from resistance training during this time frame. Subjects will undergo a five day intense resistance training protocol will on day 15 to day 19, and they will be instructed to consume their condition approximately 30 minutes prior to the training session. Subjects will complete follow-up testing in a manner identical to baseline on day 20 and 21 (24- and 48-hours post completion of the training protocol) consuming their condition approximately 30 minutes prior to their arrival at the laboratory.

The five day resistance training protocol will consist of two lower-, two upper-, and one full-body workout. Exercise sets performed on the first four days of the protocol will be targeted will repetition maximum loads such that sets will be perform to or near muscular failure. On the fifth day of the protocol, subjects will perform sets of bodyweight rear foot elevated split squats to failure for a total of 10 sets (5 sets with each leg in an alternating fashion). Subjects will be instructed to maintain the cadence set on an audible metronome, which will be set at one second downward and one second upward. Failure for these sets will be defined as 1) volitional muscle failure or 2) failure to complete two consecutive repetitions at the prescribed metronome cadence. Subjects will rest for one minute between sets. Prior to all training sessions, subjects will perform a dynamic warm-up, and following all training sessions, subjects will complete a cool down with static stretching of the targeted muscle groups with the session. All warm-up, resistance training, and cool down sessions will be supervised by trained research personnel. All training sessions will be separated by at least 24-hours.

Conditions

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Oxidative Stress Muscle Strength Resistance Training Muscle Damage Immune Suppression

Keywords

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Oxidative Stress Muscle Strength Antioxidants Resistance Training Immune Function Exercise Recovery

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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Experimental Group

Subjects will consume one serving per day (25mg) of the treatment condition (Oceanix ®) for 21 days following baseline testing. Days 1 through 14 subjects will consume the supplement with the first meal of the day and refrain from resistance training. Days 15 through 19, subjects will complete one supervised resistance training each day and consume the supplement approximately 30 minutes prior to the training session. On days 20 and 21, subjects will complete follow-up testing in a manner identical to baseline and consume the supplement approximately 30 minutes prior to their arrival at the laboratory.

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

5 days of supervised and programmed whole-body resistance training.

Placebo Group

Subjects will consume one serving per day (25mg) of the microcrystalline cellulose-based placebo condition for 21 days following baseline testing. Days 1 through 14 subjects will consume the supplement with the first meal of the day and refrain from resistance training. Days 15 through 19, subjects will complete one supervised resistance training each day and consume the supplement approximately 30 minutes prior to the training session. On days 20 and 21, subjects will complete follow-up testing in a manner identical to baseline and consume the supplement approximately 30 minutes prior to their arrival at the laboratory.

Group Type PLACEBO_COMPARATOR

Resistance Training

Intervention Type OTHER

5 days of supervised and programmed whole-body resistance training.

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

5 days of supervised and programmed whole-body resistance training.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* At least 1 year of consistent resistance training experience (i.e. three days per week).
* Physically active males and females aged 18 to 45 years old.

Exclusion Criteria

* Having a BMI of 30 or more kg/m²
* Having cardiovascular, metabolic, or endocrine disease.
* Undergone surgery that affects digestion and absorption.
* Smoker or use of smokeless tobacco
* 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.
* Fish, shellfish, algae, or seaweed allergy.
* Any history of anabolic-androgenic steroid use.
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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0519

Identifier Type: -

Identifier Source: org_study_id