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Completed

NCT Number: NCT05009654

The Effect of Leucine on Carnitine Transport to Skeletal Muscle

The primary aim of the current research project is to explore whether leucine stimulates carnitine transport, and thus affecting muscle carnitine content.

A secondary aim of this project is to investigate the effect of carnitine with leucine supplementation on muscle strength and body composition.

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Key information

Conditions

Muscle Loss Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • must be able to swallow tablets

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

Other names: L-carnitine-L-tartrate

L-leucine

Dietary Supplement

Primary outcomes

  1. Muscle Carnitine Concentration using UPLC-MS/MS

    Time frame: 24 weeks

    vastus lateralis muscle biopsy taken before and after the supplementation procedure (~20 cm proximal to the knee joint using a thin biopsy needle); carnitine concentration determined using ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS) method

Secondary outcomes

  1. Muscle Strength using Biodex System 4 Pro dynamometer

    Time frame: 24 weeks

    Peak torque measured by performing maximum voluntary contractions during isometric knee extension and flexion. The test performed in concentric-concentric mode consisting maximum 4-s knee extensor isometric contraction and maximum 4-s knee flexor isometric contraction, separated by 20-s recovery, repeated three times. Muscle isokinetic strength assessed in 5 repetitions of flexion and extension at a speed of 60°/s. Muscle endurance assessed in 10 repetitions at 300°/s determine the ability of the muscle to maintain the work. Strength testing performed on the Biodex System 4 Pro dynamometer.

  2. 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.

Sponsors and collaborators

Lead sponsor

Gdansk University of Physical Education and Sport

Other

Collaborators

  • Medical University of Gdansk

Registry information

Official study title

Carnitine Supplementation and Skeletal Muscle Function in Aging

Acronym: ROL

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 17, 2021
Registry last updated
Aug 17, 2021

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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