Carnitine Supplementation and Skeletal Muscle Mass

Muscle Loss Clinical Trial

— ROM  

Official title:

Carnitine Supplementation and Skeletal Muscle Function in Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05009641
• Other study ID #: NCN_ROM
• Secondary ID: 2014/15/B/NZ7/00
• Status: Completed
• Phase: N/A
• Start date: November 15, 2015
• Est. completion date: July 31, 2017

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 investigate the effect of carnitine supplementation on muscle strength and body composition.

A secondary aim of this project is to explore the effect of circulating trimethylamine N-oxide elevation, induced by carnitine supplementation on muscle strength and body composition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2016
• 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

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 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
Primary	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
Secondary	Plasma trimethylamine N-oxide concentration	Blood samples taken before the start and after finishing the supplementation protocol. Plasma trimethylamine N-oxide determined using ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS) method	24 weeks