SarcopeniaNCT03907592
Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function
A study testing L-carnitine supplementation, Leucine supplementation and Resistance training in people with Sarcopenia, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
Trial summary
The primary aim of the current research project is to explore whether nutritional supplementation and resistance training might be combined to produce synergistic effects in the prevention of muscle loss during aging. Read more about this study
- Who is it for?
- Ages 60 to 72 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- L-carnitine supplementation, Leucine supplementation and Resistance training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2017to 7 Jul 2018
- 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 60 to 72 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged-matched, no chronic disease, doctor's note about the lack of restrictions to perform resistance exercises
Who cannot join
- diabetes, liver, heart and renal diseases, gastric problems, as well as using the vitamin supplements
Trial locations and contacts
1 site in 1 country.
Poland1 site
University of Physical Education and Sport
Gdansk, Pomeranian Voivodeship, 80-336
About this study
Official title: Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function in Aging
The primary aim of the current research project is to explore whether nutritional supplementation and resistance training might be combined to produce synergistic effects in the prevention of muscle loss during aging.
A secondary aim of this project is to investigate the effects of carnitine with leucine supplementation, in comparison to carnitine supplementation alone, on muscle strength and body composition.
The hypothesis is that resistance training combined with nutritional supplementation have a more beneficial effect than resistance training alone in the prevention of muscle loss during aging. Leucine stimulates carnitine transport into the muscle cells, which improve mitochondrial capacity. Modification in energetic of skeletal muscle affects the body composition and muscle performance.
Read the detailed description
The study will be included volunteers - women between 60 - 72 years old (n=60). The patients are randomly assigned to two experimental groups (n=20) and control group (n=20). During the 24-weeks intervention period, Group A undergoes training procedure supplemented with the carnitine and leucine, whilst group B undergoes training procedure supplemented with leucine. At the same time control group go through only training procedure. Measurements are performed before, at the mid-point, and at the end of the intervention period.
Approximately 1 week prior to the experimental trial day, participants perform a familiarization session during which one-repetition maximum (1RM) strength testing is also performed to determine the experimental exercise load. Resistance exercise training is performed twice weekly on non-consecutive days (Monday+Thursday, or Tuesday+Friday) for 24-weeks under direct supervision by a research assistant. Prior to a training session subjects are required to perform warm - up on the treadmill (walk) and static stretching, after each session - cool down on the cycle ergometer and static stretching. Resistance exercise for each session consisted of 6 exercises: horizontal seated leg press, seated chest press, leg extension, shoulder press, lat pull-down seated row, seated cable row First two weeks of training consist of 3 sets of 10-12 repetitions and are keeping exercises at 65% of 1 repetition maximum (1RM). After this period training consists of 3 sets of 6-8 repetitions and is progressing to 80% of 1RM. The 1RM is re-evaluated every 2 weeks, and the training load is adjusted accordingly. The exercise program follows the recommended guidelines for older adults by the American College of Sports Medicine and the National Strength and Conditioning Association.
- Conditions
- Sarcopenia
- Being tested
- L-carnitine supplementation, Leucine supplementation, Resistance training
- Keywords
- L-Carnitine, Resistance training, Magnetic resonance imaging, Muscle function, Aging, Leucine
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitine supplementationDietary supplement
Supplementation of 1000 mg L-carnitine-L-tartrate in combination with 3000 mg L-leucine per day throughout the study period.
Leucine supplementationDietary supplement
Supplementation of 4000 mg L-leucine per day throughout the study period.
Resistance trainingProcedure or surgery
Resistance training at the gym, twice a week for 24 weeks (48 training units in total).
| Study group | Role | What they receive |
|---|---|---|
| L-carnitine Group | Experimental | Group participated in the training protocol and supplemented by 1000 mg L-carnitine-L-tartrate in combination with 3000 mg L-leucine per day throughout 24 weeks. Receives: Dietary Supplement: L-carnitine supplementation; Procedure: Resistance training |
| Leucine Group | Experimental | Group participated in the training protocol and supplemented by 4000mg of L-leucine per day throughout 24 weeks. Receives: Dietary Supplement: Leucine supplementation; Procedure: Resistance training |
| Control Group | Experimental | Group participated in the training protocol without any supplementation throughout 24 weeks. Receives: Procedure: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric changes in knee extensor muscle
Volumetric examination of cross section area (CSA) of knee extensor muscles determined by a 1.5 T MRI scanner.
Measured: Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.
Secondary outcomes (2)
Changes in the strength of muscle knee extensor
Maximal isometric knee extensor peak torques determined by the dynamometer (Biodex System 4 Pro).
Measured: Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.
Changes in Lean Body Mass
Lean Body Mass measured by dual-energy X-ray absorptiometry (DXA).
Measured: Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Sep 2017
- Primary completion7 Jul 2018
- Study completion7 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 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, National Science Centre, Poland
- Responsible party
- Principal investigator, Robert Olek, Gdansk University of Physical Education and Sport
- Investigators
- Robert A Olek, PhD, Principal investigator, Gdansk University of Physical Education and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907592
- Sponsor's protocol ID
- DSRiK/10/2017
- Status last verified
- Apr 2019
- First submitted
- 6 Apr 2019
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function in Aging
- ClinicalTrials.gov ID
- NCT03907592
- Acronym / sponsor ID
- DSRiK/10/2017
- Conditions
- Sarcopenia
- Keywords
- L-Carnitine, Resistance training, Magnetic resonance imaging, Muscle function, Aging, Leucine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Collaborators
- Medical University of Gdansk, National Science Centre, Poland
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 7 Jul 2018 (actual)
- Study completion
- 7 Jul 2018 (actual)
- First posted
- 9 Apr 2019 (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 explore whether nutritional supplementation and resistance training might be combined to produce synergistic effects in the prevention of muscle loss during aging.
A secondary aim of this project is to investigate the effects of carnitine with leucine supplementation, in comparison to carnitine supplementation alone, on muscle strength and body composition.
The hypothesis is that resistance training combined with nutritional supplementation have a more beneficial effect than resistance training alone in the prevention of muscle loss during aging. Leucine stimulates carnitine transport into the muscle cells, which improve mitochondrial capacity. Modification in energetic of skeletal muscle affects the body composition and muscle performance.
Detailed description
The study will be included volunteers - women between 60 - 72 years old (n=60). The patients are randomly assigned to two experimental groups (n=20) and control group (n=20). During the 24-weeks intervention period, Group A undergoes training procedure supplemented with the carnitine and leucine, whilst group B undergoes training procedure supplemented with leucine. At the same time control group go through only training procedure. Measurements are performed before, at the mid-point, and at the end of the intervention period.
Approximately 1 week prior to the experimental trial day, participants perform a familiarization session during which one-repetition maximum (1RM) strength testing is also performed to determine the experimental exercise load. Resistance exercise training is performed twice weekly on non-consecutive days (Monday+Thursday, or Tuesday+Friday) for 24-weeks under direct supervision by a research assistant. Prior to a training session subjects are required to perform warm - up on the treadmill (walk) and static stretching, after each session - cool down on the cycle ergometer and static stretching. Resistance exercise for each session consisted of 6 exercises: horizontal seated leg press, seated chest press, leg extension, shoulder press, lat pull-down seated row, seated cable row First two weeks of training consist of 3 sets of 10-12 repetitions and are keeping exercises at 65% of 1 repetition maximum (1RM). After this period training consists of 3 sets of 6-8 repetitions and is progressing to 80% of 1RM. The 1RM is re-evaluated every 2 weeks, and the training load is adjusted accordingly. The exercise program follows the recommended guidelines for older adults by the American College of Sports Medicine and the National Strength and Conditioning Association.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| L-carnitine Group | Experimental | Dietary Supplement: L-carnitine supplementation, Procedure: Resistance trainingGroup participated in the training protocol and supplemented by 1000 mg L-carnitine-L-tartrate in combination with 3000 mg L-leucine per day throughout 24 weeks. |
| Leucine Group | Experimental | Dietary Supplement: Leucine supplementation, Procedure: Resistance trainingGroup participated in the training protocol and supplemented by 4000mg of L-leucine per day throughout 24 weeks. |
| Control Group | Experimental | Procedure: Resistance trainingGroup participated in the training protocol without any supplementation throughout 24 weeks. |
Who may qualify
- Ages
- 60 to 72 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged-matched, no chronic disease, doctor's note about the lack of restrictions to perform resistance exercises
Key exclusion criteria (1 listed)
- diabetes, liver, heart and renal diseases, gastric problems, as well as using the vitamin supplements
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-carnitine supplementationSupplementation of 1000 mg L-carnitine-L-tartrate in combination with 3000 mg L-leucine per day throughout the study period. | Dietary supplement | L-carnitine Group |
| Leucine supplementationSupplementation of 4000 mg L-leucine per day throughout the study period. | Dietary supplement | Leucine Group |
| Resistance trainingResistance training at the gym, twice a week for 24 weeks (48 training units in total). | Procedure or surgery | Control Group, L-carnitine Group, Leucine Group |
Primary outcome
Volumetric changes in knee extensor muscle
Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.
Volumetric examination of cross section area (CSA) of knee extensor muscles determined by a 1.5 T MRI scanner.
2 secondary outcomes
Changes in the strength of muscle knee extensor
Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.
Changes in Lean Body Mass
Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.
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 10 Apr 2019.
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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.
Robert A Olek, PhD principal investigator
Gdansk University of Physical Education and Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-carnitine supplementation, Leucine supplementation and Resistance training in people with Sarcopenia, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
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 1 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 10 Apr 2019. 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 Poland. 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. 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?
Volumetric changes in knee extensor muscle (time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.). 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 10 Apr 2019.