Muscle LossROMNCT05009641
Carnitine Supplementation and Skeletal Muscle Mass
A study testing L-carnitine in people with Muscle Loss, run by Gdansk University of Physical Education and Sport.
Trial summary
The primary aim of the current research project is to investigate the effect of carnitine supplementation on muscle strength and body composition. A secondary aim of this project is to explore the effect of circulating trimethylamine N-oxide elevation, induced by carnitine supplementation on muscle strength and body… Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Loss
- What is being tested?
- L-carnitine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2015to 31 Jul 2017
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- must be able to swallow tablets
Who cannot join
- cardiovascular disease
- liver disease
- kidney disease
- neuromuscular disease
- gastrointestinal disorders (including stomach ulcers and erosions)
- diabetes
- other severe chronic diseases
About this study
Official title: Carnitine Supplementation and Skeletal Muscle Function in Aging
The primary aim of the current research project is to investigate the effect of carnitine supplementation on muscle strength and body composition.
A secondary aim of this project is to explore the effect of circulating trimethylamine N-oxide elevation, induced by carnitine supplementation on muscle strength and body composition.
- Conditions
- Muscle Loss
- Being tested
- L-carnitine
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitineDietary supplement
Also called L-carnitine-L-tartrate
| Study group | Role | What they receive |
|---|---|---|
| carnitine2 | Experimental | 2000 mg L-carnitine per day for 24 weeks Receives: Dietary Supplement: L-carnitine |
| carnitine | Active comparator | 1000 mg L-carnitine per day for 24 weeks Receives: Dietary Supplement: L-carnitine |
| control | No intervention | no supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength using Biodex System 4 Pro dynamometer
Peak torque measured by performing maximum voluntary contractions during isometric knee extension and flexion. The test performed in concentric-concentric mode consisting maximum 4-s knee extensor isometric contraction and maximum 4-s knee flexor isometric contraction, separated by 20-s recovery, repeated three times. Muscle isokinetic strength assessed in 5 repetitions of flexion and extension at a speed of 60°/s. Muscle endurance assessed in 10 repetitions at 300°/s determine the ability of the muscle to maintain the work. Strength testing performed on the Biodex System 4 Pro dynamometer.
Measured: 24 weeks
Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720)
The InBody720 measures impedance of five segments of the body (each arm, each leg, trunk) at frequencies of 1, 5, 50, 250, 500, and 1000 kHz through the 8-polar tactile-electrode. Based on the impedance, body fat mass, fat free mass, and skeletal muscle mass are calculated.
Measured: 24 weeks
Secondary outcomes (1)
Plasma trimethylamine N-oxide concentration
Blood samples taken before the start and after finishing the supplementation protocol. Plasma trimethylamine N-oxide determined using ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS) method
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start15 Nov 2015
- Primary completion31 Jul 2016
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle LossStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Gdansk
- Responsible party
- Principal investigator, Robert Olek, Gdansk University of Physical Education and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009641
- Sponsor's protocol ID
- NCN_ROM
- Other IDs
- 2014/15/B/NZ7/00893
- Acronym
- ROM
- Status last verified
- Aug 2021
- First submitted
- 5 Aug 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carnitine Supplementation and Skeletal Muscle Function in Aging
- ClinicalTrials.gov ID
- NCT05009641
- Acronym / sponsor ID
- ROM / NCN_ROM
- Conditions
- Muscle Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Collaborators
- Medical University of Gdansk
- Study start
- 15 Nov 2015 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 17 Aug 2021 (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.
The primary aim of the current research project is to investigate the effect of carnitine supplementation on muscle strength and body composition.
A secondary aim of this project is to explore the effect of circulating trimethylamine N-oxide elevation, induced by carnitine supplementation on muscle strength and body composition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| carnitine2 | Experimental | Dietary Supplement: L-carnitine2000 mg L-carnitine per day for 24 weeks |
| carnitine | Active comparator | Dietary Supplement: L-carnitine1000 mg L-carnitine per day for 24 weeks |
| control | No intervention | –no supplementation |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- must be able to swallow tablets
Key exclusion criteria (7 listed)
- cardiovascular disease
- liver disease
- kidney disease
- neuromuscular disease
- gastrointestinal disorders (including stomach ulcers and erosions)
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 |
|---|---|---|
| L-carnitineAlso: L-carnitine-L-tartrate | Dietary supplement | carnitine, carnitine2 |
Primary outcome
Muscle Strength using Biodex System 4 Pro dynamometer
Time frame: 24 weeks
Peak torque measured by performing maximum voluntary contractions during isometric knee extension and flexion. The test performed in concentric-concentric mode consisting maximum 4-s knee extensor isometric contraction and maximum 4-s knee flexor isometric contraction, separated by 20-s recovery, repeated three times. Muscle isokinetic strength assessed in 5 repetitions of flexion and extension at a speed of 60°/s. Muscle endurance assessed in 10 repetitions at 300°/s determine the ability of the muscle to maintain the work. Strength testing performed on the Biodex System 4 Pro dynamometer.
Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720)
Time frame: 24 weeks
The InBody720 measures impedance of five segments of the body (each arm, each leg, trunk) at frequencies of 1, 5, 50, 250, 500, and 1000 kHz through the 8-polar tactile-electrode. Based on the impedance, body fat mass, fat free mass, and skeletal muscle mass are calculated.
1 secondary outcome
Plasma trimethylamine N-oxide concentration
Time frame: 24 weeks
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 17 Aug 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing L-carnitine in people with Muscle Loss, run by Gdansk University of Physical Education and Sport.
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 7 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 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Muscle Strength using Biodex System 4 Pro dynamometer (time frame: 24 weeks). 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 17 Aug 2021.