Carnitine Supplementation and Bone Mineral Density

Study Overview
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Brief Summary
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The primary aim of the current research project is to explore whether carnitine supplementation and resistance training may prevent decrements in bone mineral density of aged women. A secondary aim of this project is to investigate the effect of supplementation on body composition and blood markers.

Detailed Description
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The study includes postmenopausal women. The subjects participate in resistance training (twice a week) for each session consisted of 6 exercises: horizontal seated leg press, seated chest press, leg extension, shoulder press, lat pull-down seated row, seated cable row. During the 24-weeks training programme participants are supplemented by carnitine with leucine, or leucine alone (placebo).

Official Title
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Effect of Carnitine Supplementation and Resistance Training on Bone Mineral Density

Conditions
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Osteoporosis

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: postmenopausal lack of restrictions to perform resistance exercises 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: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

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>* L-carnitine-L-tartrate<br>Dietary Supplement: L-leucine<br>* L-leucine<br>|
| Placebo Comparator: leucine<br>4000 mg L-leucine per day for 24 weeks | Dietary Supplement: L-leucine<br>* L-leucine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density measured by dual-energy X-ray absorptiometry (DXA) | Bone mineral density (BMD) of the femoral neck, lumbar vertebrae L1-L4, and total hip determined by Lunar Prodigy Advance DXA (GE, Healthcare, Madison, Wisconsin, USA). | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The circulating markers modification | Determination of serum interleukin-6, tumor necrosis factor alpha, C-reactive protein, and plasma trimethylamine N-oxide. | 24 weeks |