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

NCT04136821 | Completed

• 1 other identifier: ASPI0519
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Oxidative Stress; Muscle Strength; Resistance Training; Antioxidants

Outcome Measures

Primary Outcomes (6)

• Changes in muscle strength

  Assessed by isometric mid-thigh pull and isometric bench-press

  Pre, Week 2, Week 5, Week 6

• Changes in muscle power

  Assessed through ground reaction forces during countermovement- and squat-jumps on a force plate.

  Pre, Week 2, Week 5, Week 6

• Total Antioxidant Capacity (TAC)

  Experimental outcome examining total antioxidant capacity in fasted whole blood samples. The TAC measures the overall collective power of the blood to neutralize free radicals.

  Pre, Week 2, Week 5, Week 6

• Superoxide Dimutase (SOD)

  Experimental outcome examining superoxide dimutase in fasted whole blood samples. This is another protective antioxidant enzyme measured from whole blood.

  Pre, Week 2, Week 5, Week 6

• Creatine Kinase (CK)

  Experimental outcome examining creatine kinase in fasted whole blood samples. This is biomarker an indirect measure of muscle damage.

  Pre, Week 2, Week 5, Week 6

• Body Composition

  Body Composition will be assessed via dual-energy x-ray absorptiometry (DXA). Using this method, changes in total-, lean-, and fat-mass will be examined.

  Pre and Week 6

Secondary Outcomes (8)

• Rating of Perceived Exertion (RPE)

  Following every resistance training session throughout the study.

• Perceived Recovery Status (PRS)

  Prior to every resistance training session throughout the study.

• Immunoglobulin A (IgA)

  Pre, Week 2, Week 5, Week 6

• Cortisol

  Pre, Week 2, Week 5, Week 6

• Testosterone

  Pre, Week 2, Week 5, Week 6

Other Outcomes (2)

• Resting Systolic Blood Pressure

  Pre and Week 6

• Resting Diastolic Blood Pressure

  Pre and Week 6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Other: Resistance Training

Oceanix™

EXPERIMENTAL

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.

Dietary Supplement: Oceanix; 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.

Oceanix™

Resistance Training OTHER

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

Oceanix™; Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• \> 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

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: October 16, 2019
• First Posted: October 23, 2019
• Study Start: September 30, 2019
• Primary Completion: November 15, 2019
• Study Completion: January 31, 2020
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)