The Chronic Effects of Carnitine on Recovery

Sponsor
Applied Science & Performance Institute (Industry)
Overall Status
Completed
CT.gov ID
NCT04420377
Collaborator
Lonza Ltd. (Industry)
82
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24.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Carnipure
  • Other: Resistance Training
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double-blind, parallel, randomized, placebo-controlled trial.Double-blind, parallel, randomized, placebo-controlled trial.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Chronic Effects of L-Carnitine Tartrate Supplementation on Recovery
Actual Study Start Date :
Mar 2, 2020
Actual Primary Completion Date :
Jun 12, 2020
Actual Study Completion Date :
Jun 12, 2020

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 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.

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

Experimental: 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.

Dietary Supplement: Carnipure
Supplement contains L-carnitine tartrate.

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

Outcome Measures

Primary Outcome Measures

  1. Changes in Blood Markers of Muscle Damage [Baseline, Week 5, Post-Week 5]

    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.

  2. - Changes in subjective recovery scale that is directly related to recovery and inversely related to soreness. [Immediately prior to every resistance training session throughout the study.]

    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.

Secondary Outcome Measures

  1. Changes in Muscle Power [Baseline, Week 5, Post-Week 5]

    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.

  2. Changes in Muscle Strength [Baseline, Week 5, Post-Week 5]

    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.

  3. Changes in Salivary Immunoglobulin A [Baseline, Week 5, Post-Week 5]

    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.

  4. Changes in Body Composition [Baseline, Post-Week 5]

    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.

  5. Changes in Superoxide Dismutase (SOD) [Baseline, Week 5, Post-Week 5]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Applied Science and Performance Institute Tampa Florida United States 33607

Sponsors and Collaborators

  • Applied Science & Performance Institute
  • Lonza Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Applied Science & Performance Institute
ClinicalTrials.gov Identifier:
NCT04420377
Other Study ID Numbers:
  • 0220
First Posted:
Jun 9, 2020
Last Update Posted:
Feb 3, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Applied Science & Performance Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2021