The Chronic Effects of Carnitine on Recovery

NCT04420377 | Completed

• 1 other identifier: 0220
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigated the effects of CarnipureTM, a high-quality L-carnitine ingredient, on long term (5 weeks) recovery, muscle damage, and SOD status in a population of males and females while training two days per week. The primary outcomes defining recovery were changes in serum creatine kinase levels and perceptual changes in recovery. Supporting variables included an assessment of strength and power as a functional indicator of recovery. This study would be the first to examine the effects of CarnipureTM on long-term recovery. Our primary hypothesis was that L-carnitine supplementation would reduce muscle damage and improve perceptual measures of recovery. Our secondary hypotheses were that L-carnitine supplementation would better sustain strength and power and elevate SOD status.

Conditions

Muscle Soreness; Muscle Damage; Resistance Training; Oxidative Stress; Muscle Strength

Keywords

Ergogenic Aid; Muscle Recovery; Resistance Training

Outcome Measures

Primary Outcomes (2)

• Changes in Blood Markers of Muscle Damage

  Experimental outcome examining blood protein concentrations in fasted whole blood samples.This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.

  Baseline, Week 5, Post-Week 5

• - Changes in subjective recovery scale that is directly related to recovery and inversely related to soreness.

  Assessed through a visual analog scale numbered 0-10 with visual descriptors. This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.

  Immediately prior to every resistance training session throughout the study.

Secondary Outcomes (5)

• Changes in Muscle Power

  Baseline, Week 5, Post-Week 5

• Changes in Muscle Strength

  Baseline, Week 5, Post-Week 5

• Changes in Salivary Immunoglobulin A

  Baseline, Week 5, Post-Week 5

• Changes in Body Composition

  Baseline, Post-Week 5

• Changes in Superoxide Dismutase (SOD)

  Baseline, Week 5, Post-Week 5

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Participants will engage in a 5-week, whole-body, resistance training program 2 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. For week 5 of the study, participants will come in for 1 intense exercise training day.

Other: Resistance Training

Experimental Group

EXPERIMENTAL

Participants will engage in a 5-week, whole-body, resistance training program 2 days per week will consuming a treatment condition (Carnipure™) 30 minutes prior to exercise on training days or with the first meal of the day on non-training days. For week 5 of the study, participants will come in for 1 intense exercise training day.

Dietary Supplement: Carnipure; Other: Resistance Training

Interventions

Carnipure DIETARY_SUPPLEMENT

Supplement contains L-carnitine tartrate.

Experimental Group

Resistance Training OTHER

5 weeks of whole-body resistance training, performed 2 times per week.

Experimental Group; Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Participation in at least 30 minutes of moderate activity exercise 3 times per week

You may not qualify if:

• Body-mass index (BMI) of ≥ 30 kg/m²;
• Cardiovascular, metabolic, endocrine, or thyroid disease
• Smoking tobacco
• Drinking alcohol (\>7 or \>14 drinks per week for women and men, respectively)
• Pregnancy
• Hypertension
• Hyperlipidemia
• Hyperglycemia
• Thyroid disease
• Metabolic disease
• Type I or Type II Diabetes
• Use of anabolic-androgenic steroids
• Use of antioxidant supplements, NSAIDS, or nutritional supplements known to stimulate recovery or muscle mass gains, heart disease, prescription medications, dietary supplements that enhance muscle strength or muscle recovery

Sponsors & Collaborators

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

Study Sites (1)

The Applied Science and Performance Institute

Tampa, Florida, 33607, United States

Location

MeSH Terms

Conditions

Myalgia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: May 20, 2020
• First Posted: June 9, 2020
• Study Start: March 2, 2020
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)