Carnitine Supplementation and Bone Mineral Density

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Dietary Supplement: L-carnitine; Dietary Supplement: L-leucine

• Registration Number: NCT05120011
• Lead Sponsor: Poznan University of Physical Education

Brief Summary

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

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).

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-07-07
• Study Completion: 2018-07-07
• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carnitine + leucine	L-carnitine	1000 mg L-carnitine with 3000 mg L-leucine per day for 24 weeks
carnitine + leucine	L-leucine	1000 mg L-carnitine with 3000 mg L-leucine per day for 24 weeks
leucine	L-leucine	4000 mg L-leucine per day for 24 weeks

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density measured by dual-energy X-ray absorptiometry (DXA)	24 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720).	24 weeks	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.
The circulating markers modification	24 weeks	Determination of serum interleukin-6, tumor necrosis factor alpha, C-reactive protein, and plasma trimethylamine N-oxide.

Trial Locations

Locations (1)

Akademia Wychowania Fizycznego; 🇵🇱 Poznan, Poland