Carnitine Supplementation and Bone Mineral Density

August 15, 2022 updated by: Robert Olek, Poznan University of Physical Education

Effect of Carnitine Supplementation and Resistance Training on Bone Mineral Density

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Poznan, Poland, 61-871
        • Akademia Wychowania Fizycznego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Mineral Density measured by dual-energy X-ray absorptiometry (DXA)
Time Frame: 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).
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).
Time Frame: 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.
24 weeks
The circulating markers modification
Time Frame: 24 weeks
Determination of serum interleukin-6, tumor necrosis factor alpha, C-reactive protein, and plasma trimethylamine N-oxide.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Physical Education

Collaborators

Medical University of Gdansk

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

July 7, 2018

Study Completion (Actual)

July 7, 2018

Study Registration Dates

First Submitted

November 3, 2021

First Submitted That Met QC Criteria

November 3, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BW2021/RO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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