The Effect of Leucine on Carnitine Transport to Skeletal Muscle

Muscle Loss Clinical Trial

— ROL  

Official title:

Carnitine Supplementation and Skeletal Muscle Function in Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05009654
• Other study ID #: NCN_ROL
• Secondary ID: 2014/15/B/NZ7/00
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: January 31, 2018

Study information

• Verified date: August 2021
• Source: Gdansk University of Physical Education and Sport
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 31, 2018
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Loss

Intervention

Dietary Supplement:
• L-carnitine

• L-leucine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gdansk University of Physical Education and Sport	Medical University of Gdansk

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Carnitine Concentration using UPLC-MS/MS	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	Muscle Strength using Biodex System 4 Pro dynamometer	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
Secondary	Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720).	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