Carnitine Supplementation and Skeletal Muscle Function

Phase 3

Completed

• Conditions: Sarcopenia
• Interventions: Dietary Supplement: placebo; Dietary Supplement: carnitine

• Registration Number: NCT02692235
• Lead Sponsor: Gdansk University of Physical Education and Sport

Brief Summary

Research project objectives The primary aim of the current research project is to use carnitine supplementation as the anti-inflammatory intervention for exploring the relationship between inflammation and associated with aging reduction of skeletal muscle mass.

Hypothesis The carnitine supplementation modulates the blood cytokines concentration. Anti-inflammatory intervention delay the reduction of skeletal muscle mass associated with aging

Detailed Description

Volunteers over 65 years old (n=40) are supplemented either with carnitine or placebo for 24 weeks. Before the start, in the mid-point, and after finishing the supplementation the following primary outputs variables are performed: body composition analysis (InBody720), maximal isokinetic knee extensor peak torque (Biodex System 4 Pro), blood cytokines and carnitine concentration, blood lipid profile.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-13
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-26
• Primary Completion: 2017-03
• Study Completion: 2017-07
• Results First Submitted: 2017-07-17
• Results First Submitted QC: 2019-02-07
• Status Verified: 2019-05
• Results First Posted: 2019-05-09
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Subjects with no history of gastrointestinal disorders, cardiovascular disease or hypertension.

Exclusion Criteria

• Subjects having any illnesses and a history of gastrointestinal disorder, cardiovascular disease, hypertension, liver and renal disease, diabetes, cancer, alcoholism or other metabolic diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	24 weeks isonitrogenous supplementation
carnitine	carnitine	24 weeks l-carnitine-l-tartrate supplementation

Primary Outcome Measures

Name	Time	Method
Blood Inflammatory Marker	baseline and after 24 weeks of supplementation period	Serum C-reactive protein concentration determined by the enzyme immunoassay method using commercially available kit (Cloud-Clone Corp., Houston, USA)

Secondary Outcome Measures

Name	Time	Method
Lipid Metabolites	baseline and after 24 weeks of supplementation period	Change in serum lipid metabolites: total cholesterol (TCh), HDL-cholesterol (HDL), LDL-cholesterol (LDL), triglycerides (TG) determined by standard automatic analyzer Cobas 6000 (Roche Diagnostics, Mannheim, Germany)

Trial Locations

Locations (1)

University of Physical Education and Sport; 🇵🇱 Gdansk, Pomorskie, Poland