The Effect of Leucine on Carnitine Transport to Skeletal Muscle

Not Applicable

Completed

• Conditions: Muscle Loss
• Interventions: Dietary Supplement: L-carnitine; Dietary Supplement: L-leucine

• Registration Number: NCT05009654
• Lead Sponsor: Gdansk University of Physical Education and Sport

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Primary Completion: 2017-05-15
• Study Completion: 2018-01-31
• Status Verified: 2021-08
• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Study First Posted: 2021-08-17
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carnitine + leucine	L-carnitine	1000 mg L-carnitine with 3000 mg L-leucine per day for 24 weeks
carnitine + leucine	L-leucine	1000 mg L-carnitine with 3000 mg L-leucine per day for 24 weeks
leucine	L-leucine	4000 mg L-leucine per day for 24 weeks

Primary Outcome Measures

Name	Time	Method
Muscle Carnitine Concentration using UPLC-MS/MS	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 Outcome Measures

Name	Time	Method
Muscle Strength using Biodex System 4 Pro dynamometer	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.
Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720).	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.