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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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