OsteoporosisNCT05120011
Carnitine Supplementation and Bone Mineral Density
A study testing L-carnitine and L-leucine in people with Osteoporosis, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
The primary aim of the current research project is to explore whether carnitine supplementation and resistance training may prevent decrements in bone mineral density of aged women. A secondary aim of this project is to investigate the effect of supplementation on body composition and blood markers. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- L-carnitine and L-leucine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- postmenopausal
- lack of restrictions to perform resistance exercises
Who cannot join
- cardiovascular disease
- liver disease
- kidney disease
- neuromuscular disease
- gastrointestinal disorders (including stomach ulcers and erosions)
- diabetes
- other severe chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Carnitine Supplementation and Resistance Training on Bone Mineral Density
The primary aim of the current research project is to explore whether carnitine supplementation and resistance training may prevent decrements in bone mineral density of aged women.
A secondary aim of this project is to investigate the effect of supplementation on body composition and blood markers.
Read the detailed description
The study includes postmenopausal women. The subjects participate in resistance training (twice a week) 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.
During the 24-weeks training programme participants are supplemented by carnitine with leucine, or leucine alone (placebo).
- Conditions
- Osteoporosis
- Being tested
- L-carnitine, L-leucine
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitineDietary supplement
L-carnitine-L-tartrate
L-leucineDietary supplement
L-leucine
| Study group | Role | What they receive |
|---|---|---|
| carnitine + leucine | Experimental | 1000 mg L-carnitine with 3000 mg L-leucine per day for 24 weeks Receives: Dietary Supplement: L-carnitine; Dietary Supplement: L-leucine |
| leucine | Placebo comparator | 4000 mg L-leucine per day for 24 weeks Receives: Dietary Supplement: L-leucine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density measured by dual-energy X-ray absorptiometry (DXA)
Bone mineral density (BMD) of the femoral neck, lumbar vertebrae L1-L4, and total hip determined by Lunar Prodigy Advance DXA (GE, Healthcare, Madison, Wisconsin, USA).
Measured: 24 weeks
Secondary outcomes (2)
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
The circulating markers modification
Determination of serum interleukin-6, tumor necrosis factor alpha, C-reactive protein, and plasma trimethylamine N-oxide.
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 posted15 Nov 2021
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Gdansk
- Responsible party
- Principal investigator, Robert Olek, Poznan University of Physical Education
- Investigators
- Robert Olek, PhD, Principal investigator, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120011
- Sponsor's protocol ID
- BW2021/RO
- Status last verified
- Aug 2022
- First submitted
- 3 Nov 2021
- Last updated
- 16 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Olek RA, Samborowska E, Wisniewski P, Wojtkiewicz P, Wochna K, Zielinski J. Effect of a 3-month L-carnitine supplementation and resistance training program on circulating markers and bone mineral density in postmenopausal women: a randomized controlled trial. Nutr Metab (Lond). 2023 Aug 2;20(1):32. doi: 10.1186/s12986-023-00752-1.
PubMed 37533033
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Carnitine Supplementation and Resistance Training on Bone Mineral Density
- ClinicalTrials.gov ID
- NCT05120011
- Acronym / sponsor ID
- BW2021/RO
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Collaborators
- Medical University of Gdansk
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 7 Jul 2018 (actual)
- Study completion
- 7 Jul 2018 (actual)
- First posted
- 15 Nov 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 explore whether carnitine supplementation and resistance training may prevent decrements in bone mineral density of aged women.
A secondary aim of this project is to investigate the effect of supplementation on body composition and blood markers.
Detailed description
The study includes postmenopausal women. The subjects participate in resistance training (twice a week) 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.
During the 24-weeks training programme participants are supplemented by carnitine with leucine, or leucine alone (placebo).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carnitine + leucine | Experimental | Dietary Supplement: L-carnitine, Dietary Supplement: L-leucine1000 mg L-carnitine with 3000 mg L-leucine per day for 24 weeks |
| leucine | Placebo comparator | Dietary Supplement: L-leucine4000 mg L-leucine per day for 24 weeks |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- postmenopausal
- lack of restrictions to perform resistance exercises
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-carnitineL-carnitine-L-tartrate | Dietary supplement | carnitine + leucine |
| L-leucineL-leucine | Dietary supplement | carnitine + leucine, leucine |
Primary outcome
Bone Mineral Density measured by dual-energy X-ray absorptiometry (DXA)
Time frame: 24 weeks
Bone mineral density (BMD) of the femoral neck, lumbar vertebrae L1-L4, and total hip determined by Lunar Prodigy Advance DXA (GE, Healthcare, Madison, Wisconsin, USA).
2 secondary outcomes
Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720).
Time frame: 24 weeks
The circulating markers modification
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 16 Aug 2022.
- Derived from this study: PubMed 37533033Olek RA, Samborowska E, Wisniewski P, Wojtkiewicz P, Wochna K, Zielinski J. Effect of a 3-month L-carnitine supplementation and resistance training program on circulating markers and bone mineral density in postmenopausal women: a randomized controlled trial. Nutr Metab (Lond). 2023 Aug 2;20(1):32. doi: 10.1186/s12986-023-00752-1.
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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 Olek, PhD principal investigator
Poznan University of Physical Education
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 and L-leucine in people with Osteoporosis, run by Poznan University of Physical Education 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 2 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 16 Aug 2022. 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. 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?
Bone Mineral Density measured by dual-energy X-ray absorptiometry (DXA) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05120011, which also lists 1 linked publication.
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 16 Aug 2022; AzTrials last refreshed its copy on 30 Oct 2026.