Clinical trial NCT04420377: The Chronic Effects of Carnitine on Recovery
Official title: The Chronic Effects of L-Carnitine Tartrate Supplementation on Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Soreness
Muscle Damage
Resistance Training
Oxidative Stress
Muscle Strength
Keywords: Ergogenic Aid
Muscle Recovery
Resistance Training
Lead sponsor: Applied Science & Performance Institute
Sponsor class: INDUSTRY
Collaborators: name: Lonza Ltd.
First posted: 2020-06-09
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, parallel, randomized, placebo-controlled trial.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Blood Markers of Muscle Damage
timeFrame: Baseline, Week 5, Post-Week 5
measure: - Changes in subjective recovery scale that is directly related to recovery and inversely related to soreness.
timeFrame: Immediately prior to every resistance training session throughout the study.
Secondary outcomes:
measure: Changes in Muscle Power
timeFrame: Baseline, Week 5, Post-Week 5
measure: Changes in Muscle Strength
timeFrame: Baseline, Week 5, Post-Week 5
measure: Changes in Salivary Immunoglobulin A
timeFrame: Baseline, Week 5, Post-Week 5
measure: Changes in Body Composition
timeFrame: Baseline, Post-Week 5
measure: Changes in Superoxide Dismutase (SOD)
timeFrame: Baseline, Week 5, Post-Week 5
Other outcomes:
Locations:
city: Tampa
country: United States
facility: The Applied Science and Performance Institute
state: Florida
Study officials:
References: