The Short Term Effects of Oceanix Supplementation on Recovery

NCT04315077 | Completed

• 1 other identifier: 0519
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Oxidative Stress; Muscle Strength; Resistance Training; Muscle Damage; Immune Suppression

Keywords

Oxidative Stress; Muscle Strength; Antioxidants; Resistance Training; Immune Function; Exercise Recovery

Outcome Measures

Primary Outcomes (2)

• Changes in Muscle Strength (Forces exerted in kg)

  Assessed by Isometric Mid-Thigh Pull.

  Baseline, 24-Hours Post Last Training Day, 48-Hours Post Last Training Day

• Changes in Rate of Force Development (Newtons per second)

  Assessed by Isometric Mid-Thigh Pull

  Baseline, 24-Hours Post Last Training Day, 48-Hours Post Last Training Day

Secondary Outcomes (1)

• Immunoglobulin A (micrograms per milliliter)

  Baseline, 24-Hours Post Last Training Day, 48-Hours Post Last Training Day

Other Outcomes (1)

• Repetitions Executed on a Bodyweight Rear Foot Elevated Split Squats

  Fifth (Last) Day of Training Regimen.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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®; Other: Resistance Training

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Oceanix® DIETARY_SUPPLEMENT

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

Experimental Group

Resistance Training OTHER

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

Experimental Group; Placebo Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Applied Science & Performance Institute: lead
• Lonza Ltd.: collaborator

Study Sites (1)

Applied Science & Performance Institute

Tampa, Florida, 33607, United States

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-Blind, Parallel, Randomized, Placebo-Controlled Trial

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 19, 2020
• Study Start: October 1, 2019
• Primary Completion: November 23, 2019
• Study Completion: November 25, 2019
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

US (1)