The Chronic Effects of Carnitine on Recovery

Oxidative Stress Clinical Trial

Official title:

The Chronic Effects of L-Carnitine Tartrate Supplementation on Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420377
• Other study ID #: 0220
• Status: Completed
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: June 12, 2020

Study information

• Verified date: February 2021
• Source: Applied Science & Performance Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 12, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Damage
• Muscle Soreness
• Muscle Strength
• Myalgia
• Oxidative Stress
• Resistance Training

Intervention

Dietary Supplement:
• Carnipure
Supplement contains L-carnitine tartrate.

Other:
• Resistance Training
5 weeks of whole-body resistance training, performed 2 times per week.

Locations

Country	Name	City	State
United States	The Applied Science and Performance Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Applied Science & Performance Institute	Lonza Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	- 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	Changes in Muscle Power	Assessed through ground reaction forces during countermovement- and squat-jumps on a force plate. 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
Secondary	Changes in Muscle Strength	Assessed by isometric mid-thigh pull. 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
Secondary	Changes in Salivary Immunoglobulin A	Experimental outcome examining the concentration of IgA in fasted saliva 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
Secondary	Changes in 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. This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.	Baseline, Post-Week 5
Secondary	Changes in Superoxide Dismutase (SOD)	Experimental outcome examining superoxide dismutase in fasted whole blood samples. This is another protective antioxidant enzyme measured from whole blood. 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