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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04420377
Other study ID # 0220
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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