Carnitine Supplementation and Bone Mineral Density

Osteoporosis Clinical Trial

Official title:

Effect of Carnitine Supplementation and Resistance Training on Bone Mineral Density

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05120011
• Other study ID #: BW2021/RO
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 7, 2018

Study information

• Verified date: August 2022
• Source: Poznan University of Physical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 7, 2018
• Est. primary completion date: July 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Dietary Supplement:
• L-carnitine
L-carnitine-L-tartrate
• L-leucine
L-leucine

Locations

Country	Name	City	State
Poland	Akademia Wychowania Fizycznego	Poznan

Sponsors (2)

Lead Sponsor	Collaborator
Poznan University of Physical Education	Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The circulating markers modification	Determination of serum interleukin-6, tumor necrosis factor alpha, C-reactive protein, and plasma trimethylamine N-oxide.	24 weeks