Sarcopenia
Conditions
Keywords
carnitine
Brief summary
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
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTplacebo
isonitrogenous
DIETARY_SUPPLEMENTcarnitine
1500 mg/d l-carnitine-l-tartrate
Sponsors
National Science Centre, Poland
Gdansk University of Physical Education and Sport
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects with no history of gastrointestinal disorders, cardiovascular disease or hypertension.
Exclusion criteria
* Subjects having any illnesses and a history of gastrointestinal disorder, cardiovascular disease, hypertension, liver and renal disease, diabetes, cancer, alcoholism or other metabolic diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Inflammatory Marker | baseline and after 24 weeks of supplementation period | Serum C-reactive protein concentration determined by the enzyme immunoassay method using commercially available kit (Cloud-Clone Corp., Houston, USA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid Metabolites | baseline and after 24 weeks of supplementation period | 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) |
Countries
Poland
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Carnitine 24 weeks l-carnitine-l-tartrate supplementation
carnitine: 1500 mg/d l-carnitine-l-tartrate | 14 |
| Placebo 24 weeks isonitrogenous supplementation
placebo: isonitrogenous | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Carnitine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 14 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Body Mass Index (BMI) | 28.2 kg/m² STANDARD_DEVIATION 4.5 | 28.0 kg/m² STANDARD_DEVIATION 5.9 | 28.1 kg/m² STANDARD_DEVIATION 5.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 1 / 14 | 2 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
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
Population: 1 male and 1 smoking female subjects excluded from the \*Placebo\* statistical analyses for group homogeneity
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carnitine | Blood Inflammatory Marker | baseline | 2.6 mg·L^-1 | Standard Deviation 0.3 |
| Carnitine | Blood Inflammatory Marker | after 24 weeks | 2.9 mg·L^-1 | Standard Deviation 0.4 |
| Placebo | Blood Inflammatory Marker | baseline | 1.8 mg·L^-1 | Standard Deviation 0.3 |
| Placebo | Blood Inflammatory Marker | after 24 weeks | 1.7 mg·L^-1 | Standard Deviation 0.3 |
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)
Time frame: baseline and after 24 weeks of supplementation period
Population: 1 male and 1 smoking female subjects excluded from the \*Placebo\* statistical analyses for group homogeneity
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carnitine | Lipid Metabolites | TCh baseline | 233 mg·dL^-1 | Standard Deviation 13 |
| Carnitine | Lipid Metabolites | TCh after 24 weeks | 221 mg·dL^-1 | Standard Deviation 14 |
| Carnitine | Lipid Metabolites | HDL baseline | 69 mg·dL^-1 | Standard Deviation 5 |
| Carnitine | Lipid Metabolites | HDL after 24 weeks | 69 mg·dL^-1 | Standard Deviation 5 |
| Carnitine | Lipid Metabolites | LDL baseline | 140 mg·dL^-1 | Standard Deviation 11 |
| Carnitine | Lipid Metabolites | LDL after 24 weeks | 131 mg·dL^-1 | Standard Deviation 11 |
| Carnitine | Lipid Metabolites | TG baseline | 116 mg·dL^-1 | Standard Deviation 10 |
| Carnitine | Lipid Metabolites | TG after 24 weeks | 105 mg·dL^-1 | Standard Deviation 16 |
| Placebo | Lipid Metabolites | TG after 24 weeks | 98 mg·dL^-1 | Standard Deviation 16 |
| Placebo | Lipid Metabolites | TCh baseline | 221 mg·dL^-1 | Standard Deviation 13 |
| Placebo | Lipid Metabolites | LDL baseline | 130 mg·dL^-1 | Standard Deviation 11 |
| Placebo | Lipid Metabolites | TCh after 24 weeks | 196 mg·dL^-1 | Standard Deviation 14 |
| Placebo | Lipid Metabolites | TG baseline | 117 mg·dL^-1 | Standard Deviation 22 |
| Placebo | Lipid Metabolites | HDL baseline | 68 mg·dL^-1 | Standard Deviation 6 |
| Placebo | Lipid Metabolites | LDL after 24 weeks | 115 mg·dL^-1 | Standard Deviation 13 |
| Placebo | Lipid Metabolites | HDL after 24 weeks | 61 mg·dL^-1 | Standard Deviation 3 |