The Short Term Effects of Oceanix Supplementation on Recovery

Sponsor

Applied Science & Performance Institute (Industry)

Overall Status

Completed

CT.gov ID

NCT04315077

Collaborator

Lonza Ltd. (Industry)

Enrollment

Location

Arms

1.8

Actual Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Oxidative Stress Muscle Strength Resistance Training Muscle Damage Immune Suppression	Dietary Supplement: Oceanix® Other: Resistance Training	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double-Blind, Parallel, Randomized, Placebo-Controlled TrialDouble-Blind, Parallel, Randomized, Placebo-Controlled Trial

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effects of Short Term Oceanix Supplementation on Muscle Mass, Strength, and Power Underneath Extreme Training Conditions in Healthy and Elite Athletic Populations

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Nov 23, 2019

Actual Study Completion Date :

Nov 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: Oceanix® Ingredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals. Other: Resistance Training 5 days of supervised and programmed whole-body resistance training.
Placebo Comparator: 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.	Other: Resistance Training 5 days of supervised and programmed whole-body resistance training.

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: Oceanix®

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

Other: Resistance Training

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

Placebo Comparator: 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.

Other: Resistance Training

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

Outcome Measures

Primary Outcome Measures

Changes in Muscle Strength (Forces exerted in kg) [Baseline, 24-Hours Post Last Training Day, 48-Hours Post Last Training Day]
Assessed by Isometric Mid-Thigh Pull.
Changes in Rate of Force Development (Newtons per second) [Baseline, 24-Hours Post Last Training Day, 48-Hours Post Last Training Day]
Assessed by Isometric Mid-Thigh Pull

Secondary Outcome Measures

Immunoglobulin A (micrograms per milliliter) [Baseline, 24-Hours Post Last Training Day, 48-Hours Post Last Training Day]
Experimental outcome examining the concentration of immunoglobulin A in fasted saliva sample.

Other Outcome Measures

Repetitions Executed on a Bodyweight Rear Foot Elevated Split Squats [Fifth (Last) Day of Training Regimen.]
Recorded the number of repetitions executed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.