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| Name | Class |
|---|---|
| National Science Centre, Poland | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carnitine | Experimental | 24 weeks l-carnitine-l-tartrate supplementation |
|
| placebo | Placebo Comparator | 24 weeks isonitrogenous supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carnitine | Dietary Supplement | 1500 mg/d l-carnitine-l-tartrate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Inflammatory Marker | Serum C-reactive protein concentration determined by the enzyme immunoassay method using commercially available kit (Cloud-Clone Corp., Houston, USA) | baseline and after 24 weeks of supplementation period |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline and after 24 weeks of supplementation period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert A Olek, PhD | Gdansk University of Physical Education and Sport | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Physical Education and Sport | Gdansk | Pomeranian Voivodeship | 80-336 | Poland |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Carnitine | 24 weeks l-carnitine-l-tartrate supplementation carnitine: 1500 mg/d l-carnitine-l-tartrate |
| FG001 | Placebo | 24 weeks isonitrogenous supplementation placebo: isonitrogenous |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carnitine | 24 weeks l-carnitine-l-tartrate supplementation carnitine: 1500 mg/d l-carnitine-l-tartrate |
| BG001 | Placebo | 24 weeks isonitrogenous supplementation placebo: isonitrogenous |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Inflammatory Marker | Serum C-reactive protein concentration determined by the enzyme immunoassay method using commercially available kit (Cloud-Clone Corp., Houston, USA) | 1 male and 1 smoking female subjects excluded from the *Placebo* statistical analyses for group homogeneity | Posted | Mean | Standard Deviation | mg·L^-1 | baseline and after 24 weeks of supplementation period |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carnitine | 24 weeks l-carnitine-l-tartrate supplementation carnitine: 1500 mg/d l-carnitine-l-tartrate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acid reflux | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Olek | AWFiS | +48 58 5547392 | robol@awf.gda.pl |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2017 | Feb 28, 2018 | SAP_000.pdf |
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jun 22, 2015 | Feb 28, 2018 | Prot_ICF_001.pdf |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| placebo |
| Dietary Supplement |
isonitrogenous |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
|
|
|
| Secondary | 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) | 1 male and 1 smoking female subjects excluded from the *Placebo* statistical analyses for group homogeneity | Posted | Mean | Standard Deviation | mg·dL^-1 | baseline and after 24 weeks of supplementation period |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | Placebo | 24 weeks isonitrogenous supplementation placebo: isonitrogenous | 0 | 14 | 0 | 14 | 2 | 14 |
| headache and dizziness | General disorders | Non-systematic Assessment |
|
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| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| HDL baseline |
|
| HDL after 24 weeks |
|
| LDL baseline |
|
| LDL after 24 weeks |
|
| TG baseline |
|
| TG after 24 weeks |
|