The Chronic Effects of Carnitine on Recovery

NCT ID: NCT04420377

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2020-06-12

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.

Detailed Description

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.

In totality, the study will last 5-weeks, consisting of supplementation with maintenance exercise performed 2 days per week, at home. Week 5 will consist of a pre-training assessment, an intense lower-body strength endurance training day, and subsequent testing 48-hour testing (Post-Week 5). The baseline testing (will be performed on approximately 10 subjects per day over the course of 4 days) and will consist of the following measures:

• DEXA (Dual Energy X-ray Absorptiometry) Body Composition Analysis
• Blood Draw
• Salivary Measures
• Isometric Mid Thigh Pull
• Force Plate Mechanography
• Visual Analog Scales

For the first 4 weeks of training, participants will be asked to workout 2 days per week at home.

On Monday of week five, 20 subjects will be assessed on the following measures:

• DXA
• Blood Draw
• Salivary Measures
• Isometric Mid Thigh Pull
• Force Plate Mechanography
• Visual Analog Scales

On Tuesday of week 5, the 20 subjects that tested on Monday, will go through an intense lower body, strength endurance protocol, and the leftover 20 subjects will go through the following assessments:

• DXA
• Blood Draw
• Salivary Measures
• Isometric Mid Thigh Pull
• Force Plate Mechanography
• Visual Analog Scales
• Before and After the workout - Finger Prick Blood Sample

On Wednesday of week 5, the 20 subjects that tested Monday, will have a day to rest. The 20 subjects that tested Tuesday, will go through an intense lower body strength endurance protocol.

• Before and After the workout - Finger Prick Blood Sample (for blood lactate)

On Thursday of week 5, the 20 subjects that tested Tuesday will have the day off, while the 20 subjects that tested Monday will be assessed on the following measures:

• Blood Draw
• Salivary Measures
• Isometric Mid Thigh Pull
• Force Plate Mechanography
• Visual Analog Scales

On Friday of week 5, the 20 subjects that tested Tuesday will be assessed on the following measures:

• Blood Draw
• Salivary Measures
• Isometric Mid Thigh Pull
• Force Plate Mechanography
• Visual Analog Scales

Participation will be sought from 80 male and female subjects ranging from 21 to 65 years old who are active (i.e. 30 minutes per week of moderate activity classified as greater than 50 % of their heart rate (HR) max 3 days • week-1). Two cohorts of 40 subjects will be examined in the study.

The supplement will be administered as a dose of 2g of Carnipure (L-carnitine), per day for the duration of the study. Placebo and treatment conditions will be administered in visually identical capsules. Statistical analysis will be carried out on the entire study population and on the female study population independently.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo Group

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.

Group Type: PLACEBO_COMPARATOR

Resistance Training

Intervention Type: OTHER

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

Experimental Group

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.

Group Type: EXPERIMENTAL

Carnipure

Intervention Type: DIETARY_SUPPLEMENT

Supplement contains L-carnitine tartrate.

Resistance Training

Intervention Type: OTHER

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

Interventions

Carnipure

Supplement contains L-carnitine tartrate.

Intervention Type: DIETARY_SUPPLEMENT

Resistance Training

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lonza Ltd.

INDUSTRY

Sponsor Role: collaborator

Applied Science & Performance Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Applied Science and Performance Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

0220

Identifier Type: -

Identifier Source: org_study_id