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Completed

NCT Number: NCT05120011

Carnitine Supplementation and 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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

60 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Akademia Wychowania Fizycznego

Poznan, 61-871, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-carnitine

Dietary Supplement

L-carnitine-L-tartrate

L-leucine

Dietary Supplement

L-leucine

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Poznan University of Physical Education

Other

Collaborators

  • Medical University of Gdansk

Registry information

Official study title

Effect of Carnitine Supplementation and Resistance Training on Bone Mineral Density

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 15, 2021
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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