Carnitine Supplementation and Skeletal Muscle Function

Carnitine Supplementation and Skeletal Muscle Function in Aging

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

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: carnitine; Dietary supplement: placebo

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-336
      • University of Physical Education and Sport

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 70 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: carnitine; 24 weeks l-carnitine-l-tartrate supplementation	Dietary supplement: carnitine; 1500 mg/d l-carnitine-l-tartrate
Placebo Comparator: placebo; 24 weeks isonitrogenous supplementation	Dietary supplement: placebo; isonitrogenous

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid Metabolites	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)	baseline and after 24 weeks of supplementation period

Collaborators and Investigators

• Sponsor: Gdansk University of Physical Education and Sport
• Collaborators: National Science Centre, Poland

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: February 13, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: carnitine
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 2014/15/B/NZ7/00893 (Other Grant/Funding Number: National Science Centre)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No