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NCT Number: NCT02692235

Carnitine Supplementation and Skeletal Muscle Function

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

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Physical Education and Sport

Gdansk, Pomeranian Voivodeship, 80-336, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

carnitine

Dietary Supplement

1500 mg/d l-carnitine-l-tartrate

Placebo

Dietary Supplement

isonitrogenous

Primary outcomes

  1. Blood Inflammatory Marker

    Time frame: 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 outcomes

  1. Lipid Metabolites

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Gdansk University of Physical Education and Sport

Other

Collaborators

  • National Science Centre, Poland

Registry information

Official study title

Carnitine Supplementation and Skeletal Muscle Function in Aging

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2016
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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