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The Chronic Effects of Carnitine on Recovery

Primary Purpose

Muscle Soreness, Muscle Damage, Resistance Training

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carnipure
Resistance Training
Sponsored by
Applied Science & Performance Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Soreness focused on measuring Ergogenic Aid, Muscle Recovery, Resistance Training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Applied Science and Performance Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Group

Experimental Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
- 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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
May 20, 2020
Last Updated
February 2, 2021
Sponsor
Applied Science & Performance Institute
Collaborators
Lonza Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04420377
Brief Title
The Chronic Effects of Carnitine on Recovery
Official Title
The Chronic Effects of L-Carnitine Tartrate Supplementation on Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
June 12, 2020 (Actual)
Study Completion Date
June 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Applied Science & Performance Institute
Collaborators
Lonza Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Soreness, Muscle Damage, Resistance Training, Oxidative Stress, Muscle Strength
Keywords
Ergogenic Aid, Muscle Recovery, Resistance Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, parallel, randomized, placebo-controlled trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carnipure
Intervention Description
Supplement contains L-carnitine tartrate.
Intervention Type
Other
Intervention Name(s)
Resistance Training
Intervention Description
5 weeks of whole-body resistance training, performed 2 times per week.
Primary Outcome Measure Information:
Title
Changes in Blood Markers of Muscle Damage
Description
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.
Time Frame
Baseline, Week 5, Post-Week 5
Title
- Changes in subjective recovery scale that is directly related to recovery and inversely related to soreness.
Description
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.
Time Frame
Immediately prior to every resistance training session throughout the study.
Secondary Outcome Measure Information:
Title
Changes in Muscle Power
Description
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.
Time Frame
Baseline, Week 5, Post-Week 5
Title
Changes in Muscle Strength
Description
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.
Time Frame
Baseline, Week 5, Post-Week 5
Title
Changes in Salivary Immunoglobulin A
Description
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.
Time Frame
Baseline, Week 5, Post-Week 5
Title
Changes in Body Composition
Description
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.
Time Frame
Baseline, Post-Week 5
Title
Changes in Superoxide Dismutase (SOD)
Description
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.
Time Frame
Baseline, Week 5, Post-Week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
The Applied Science and Performance Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no intentions of sharing IPD with other researchers.

Learn more about this trial

The Chronic Effects of Carnitine on Recovery

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