Carnitine Supplementation and Skeletal Muscle Function

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Carnitine Supplementation and Skeletal Muscle Function in Aging

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: carnitine
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carnitine<br>24 weeks l-carnitine-l-tartrate supplementation | Dietary Supplement: carnitine<br>* 1500 mg/d l-carnitine-l-tartrate<br>|
| Placebo Comparator: placebo<br>24 weeks isonitrogenous supplementation | Dietary Supplement: placebo<br>* isonitrogenous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carnitine