The Effect of Leucine on Carnitine Transport to Skeletal Muscle (ROL)

August 11, 2021 updated by: Robert Olek, Gdansk University of Physical Education and Sport

Carnitine Supplementation and Skeletal Muscle Function in Aging

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

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

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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
Other Names:
  • L-carnitine-L-tartrate
Dietary supplement: L-leucine
Placebo Comparator: leucine
4000 mg L-leucine per day for 24 weeks
Dietary supplement: L-leucine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks
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

Collaborators and Investigators

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

Sponsor

Gdansk University of Physical Education and Sport

Collaborators

Medical University of Gdansk

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)

October 1, 2016

Primary Completion (Actual)

May 15, 2017

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

August 5, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • NCN_ROL
  • 2014/15/B/NZ7/00893 (Other Grant/Funding Number: National Science Centre)

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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