The Effect of Leucine on Carnitine Transport to Skeletal Muscle

Study Overview
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Brief Summary
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The primary aim of the current research project is to explore whether leucine stimulates carnitine transport, and thus affecting muscle carnitine content. A secondary aim of this project is to investigate the effect of carnitine with leucine supplementation on muscle strength and body composition.

Official Title
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Carnitine Supplementation and Skeletal Muscle Function in Aging

Conditions
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Muscle Loss

Intervention / Treatment
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* Dietary Supplement: L-carnitine
* Dietary Supplement: L-leucine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must be able to swallow tablets Exclusion Criteria: cardiovascular disease liver disease kidney disease neuromuscular disease gastrointestinal disorders (including stomach ulcers and erosions) diabetes other severe chronic diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 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 + leucine<br>1000 mg L-carnitine with 3000 mg L-leucine per day for 24 weeks | Dietary Supplement: L-carnitine<br> <br> * Other names: L-carnitine-L-tartrate;Dietary Supplement: L-leucine<br> <br> |
| Placebo Comparator: leucine<br>4000 mg L-leucine per day for 24 weeks | Dietary Supplement: L-leucine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Carnitine Concentration using UPLC-MS/MS | vastus lateralis muscle biopsy taken before and after the supplementation procedure ( 20 cm proximal to the knee joint using a thin biopsy needle); carnitine concentration determined using ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS) method | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength using Biodex System 4 Pro dynamometer | Peak torque measured by performing maximum voluntary contractions during isometric knee extension and flexion. The test performed in concentric-concentric mode consisting maximum 4-s knee extensor isometric contraction and maximum 4-s knee flexor isometric contraction, separated by 20-s recovery, repeated three times. Muscle isokinetic strength assessed in 5 repetitions of flexion and extension at a speed of 60°/s. Muscle endurance assessed in 10 repetitions at 300°/s determine the ability of the muscle to maintain the work. Strength testing performed on the Biodex System 4 Pro dynamometer. | 24 weeks | 
| 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. | 24 weeks |