Muscle SorenessNCT04420377
The Chronic Effects of Carnitine on Recovery
A study testing Carnipure and Resistance Training in people with Muscle Soreness and Muscle Damage, run by Applied Science & Performance Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness, Muscle Damage, Resistance Training
- What is being tested?
- Carnipure and Resistance Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2020to 12 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participation in at least 30 minutes of moderate activity exercise 3 times per week
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Applied Science and Performance Institute
Tampa, Florida, 33607
About this study
Official title: The Chronic Effects of L-Carnitine Tartrate Supplementation on Recovery
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.
Read the 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.
- Being tested
- Carnipure, Resistance Training
- Keywords
- Ergogenic Aid, Muscle Recovery, Resistance Training
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarnipureDietary supplement
Supplement contains L-carnitine tartrate.
Resistance TrainingOther
5 weeks of whole-body resistance training, performed 2 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | 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. Receives: Other: Resistance Training |
| Experimental Group | Experimental | 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. Receives: Dietary Supplement: Carnipure; Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 5, Post-Week 5
- 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.
Measured: Immediately prior to every resistance training session throughout the study.
Secondary outcomes (5)
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.
Measured: Baseline, Week 5, Post-Week 5
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.
Measured: Baseline, Week 5, Post-Week 5
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.
Measured: Baseline, Week 5, Post-Week 5
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.
Measured: Baseline, Post-Week 5
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.
Measured: Baseline, Week 5, Post-Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start2 Mar 2020
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SorenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, parallel, randomized, placebo-controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science & Performance Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lonza Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420377
- Sponsor's protocol ID
- 0220
- Status last verified
- Feb 2021
- First submitted
- 20 May 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no intentions of sharing IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chronic Effects of L-Carnitine Tartrate Supplementation on Recovery
- ClinicalTrials.gov ID
- NCT04420377
- Acronym / sponsor ID
- 0220
- Keywords
- Ergogenic Aid, Muscle Recovery, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Lonza Ltd.
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, parallel, randomized, placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Other: Resistance TrainingParticipants 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. |
| Experimental Group | Experimental | Dietary Supplement: Carnipure, Other: Resistance TrainingParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in at least 30 minutes of moderate activity exercise 3 times per week
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarnipureSupplement contains L-carnitine tartrate. | Dietary supplement | Experimental Group |
| Resistance Training5 weeks of whole-body resistance training, performed 2 times per week. | Other | Experimental Group, Placebo Group |
Primary outcome
Changes in Blood Markers of Muscle Damage
Time frame: 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.
- Changes in subjective recovery scale that is directly related to recovery and inversely related to soreness.
Time frame: 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.
5 secondary outcomes
Changes in Muscle Power
Time frame: Baseline, Week 5, Post-Week 5
Changes in Muscle Strength
Time frame: Baseline, Week 5, Post-Week 5
Changes in Salivary Immunoglobulin A
Time frame: Baseline, Week 5, Post-Week 5
Changes in Body Composition
Time frame: Baseline, Post-Week 5
Changes in Superoxide Dismutase (SOD)
Time frame: Baseline, Week 5, Post-Week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No. There are no intentions of sharing IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carnipure and Resistance Training in people with Muscle Soreness and Muscle Damage, run by Applied Science & Performance Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Blood Markers of Muscle Damage (time frame: Baseline, Week 5, Post-Week 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.