A Phase 3 interventional study of carnitine and placebo in Sarcopenia, sponsored by Gdansk University of Physical Education and Sport. Completed at 1 site in Poland. Open to participants aged 65 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-23.
Sponsored by Gdansk University of Physical Education and Sport · Phase 3, Interventional, and Prevention
Research project objectives The primary aim of the current research project is to use carnitine supplementation as the anti-inflammatory intervention for exploring the relationship between inflammation and associated with aging reduction of skeletal muscle mass.
Hypothesis The carnitine supplementation modulates the blood cytokines concentration. Anti-inflammatory intervention delay the reduction of skeletal muscle mass associated with aging
Volunteers over 65 years old (n=40) are supplemented either with carnitine or placebo for 24 weeks. Before the start, in the mid-point, and after finishing the supplementation the following primary outputs variables are performed: body composition analysis (InBody720), maximal isokinetic knee extensor peak torque (Biodex System 4 Pro), blood cytokines and carnitine concentration, blood lipid profile.
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's enrollment of 28 is below the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Gdansk University of Physical Education and Sport is the lead sponsor of 34 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
24 weeks l-carnitine-l-tartrate supplementation
Dietary Supplement: carnitine
24 weeks isonitrogenous supplementation
Dietary Supplement: placebo
1500 mg/d l-carnitine-l-tartrate
isonitrogenous
Blood Inflammatory Marker
Serum C-reactive protein concentration determined by the enzyme immunoassay method using commercially available kit (Cloud-Clone Corp., Houston, USA)
Time frame: baseline and after 24 weeks of supplementation period
Lipid Metabolites
Change in serum lipid metabolites: total cholesterol (TCh), HDL-cholesterol (HDL), LDL-cholesterol (LDL), triglycerides (TG) determined by standard automatic analyzer Cobas 6000 (Roche Diagnostics, Mannheim, Germany)
Time frame: baseline and after 24 weeks of supplementation period
42 subjects volunteered to participate in the study. After the initial screening, 28 were included in the study (14 subject not meeting inclusion criteria) and were randomly assigned to either an L-carnitine (n=14) or a placebo supplementation group (n=14).
| Milestone | Carnitine | Placebo |
|---|---|---|
| Started | 14 | 14 |
| Completed | 11 | 11 |
| Not completed | 3 | 3 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Adverse event | 1 | 2 |
Serum C-reactive protein concentration determined by the enzyme immunoassay method using commercially available kit (Cloud-Clone Corp., Houston, USA)
| mg·L^-1 | Carnitine | Placebo |
|---|---|---|
| baseline | 2.6 ± 0.3 | 1.8 ± 0.3 |
| after 24 weeks | 2.9 ± 0.4 | 1.7 ± 0.3 |
Change in serum lipid metabolites: total cholesterol (TCh), HDL-cholesterol (HDL), LDL-cholesterol (LDL), triglycerides (TG) determined by standard automatic analyzer Cobas 6000 (Roche Diagnostics, Mannheim, Germany)
| mg·dL^-1 | Carnitine | Placebo |
|---|---|---|
| TCh baseline | 233 ± 13 | 221 ± 13 |
| TCh after 24 weeks | 221 ± 14 | 196 ± 14 |
| HDL baseline | 69 ± 5 | 68 ± 6 |
| HDL after 24 weeks | 69 ± 5 | 61 ± 3 |
| LDL baseline | 140 ± 11 | 130 ± 11 |
| LDL after 24 weeks | 131 ± 11 | 115 ± 13 |
| TG baseline | 116 ± 10 | 117 ± 22 |
| TG after 24 weeks | 105 ± 16 | 98 ± 16 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Carnitine | 0/14 (0%) | 0/14 (0%) | 1/14 (7.1%) |
| Placebo | 0/14 (0%) | 0/14 (0%) | 2/14 (14.3%) |
| Event | Carnitine | Placebo |
|---|---|---|
| acid refluxGastrointestinal disorders | 1/14 | 1/14 |
| headache and dizzinessGeneral disorders | 0/14 | 1/14 |
| Age, Categorical(Participants) | Carnitine | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 14 | 14 | 28 |
| Sex: Female, Male(Participants) | Carnitine | Placebo | Total |
|---|---|---|---|
| Female | 14 | 13 | 27 |
| Male | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Carnitine | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 14 | 14 | 28 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Body Mass Index (BMI)(kg/m²) | Carnitine | Placebo | Total |
|---|---|---|---|
| Mean | 28.2 ± 4.5 | 28.0 ± 5.9 | 28.1 ± 5.2 |
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Plan to share: No
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Gdansk University of Physical Education and Sport