Carnitine Supplementation and Bone Mineral Density

Sponsor

Poznan University of Physical Education (Other)

Overall Status

Completed

CT.gov ID

NCT05120011

Collaborator

Medical University of Gdansk (Other)

Enrollment

Location

Arms

10.2

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Dietary Supplement: L-carnitine Dietary Supplement: L-leucine	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Effect of Carnitine Supplementation and Resistance Training on Bone Mineral Density

Actual Study Start Date :

Sep 1, 2017

Actual Primary Completion Date :

Jul 7, 2018

Actual Study Completion Date :

Jul 7, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: carnitine + leucine 1000 mg L-carnitine with 3000 mg L-leucine per day for 24 weeks	Dietary Supplement: L-carnitine L-carnitine-L-tartrate Dietary Supplement: L-leucine L-leucine
Placebo Comparator: leucine 4000 mg L-leucine per day for 24 weeks	Dietary Supplement: L-leucine L-leucine

Arm

Intervention/Treatment

Experimental: carnitine + leucine

1000 mg L-carnitine with 3000 mg L-leucine per day for 24 weeks

Dietary Supplement: L-carnitine

L-carnitine-L-tartrate

Dietary Supplement: L-leucine

L-leucine

Placebo Comparator: leucine

4000 mg L-leucine per day for 24 weeks

Dietary Supplement: L-leucine

L-leucine

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akademia Wychowania Fizycznego	Poznan		Poland	61-871

Sponsors and Collaborators

Poznan University of Physical Education
Medical University of Gdansk

Investigators

Principal Investigator: Robert Olek, PhD, Poznan University of Physical Education

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Olek, Principal Investigator, Poznan University of Physical Education

ClinicalTrials.gov Identifier:

NCT05120011

Other Study ID Numbers:

BW2021/RO

First Posted:

Nov 15, 2021

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoporosis

Study Results

No Results Posted as of Aug 16, 2022