Carnitine Supplementation and Skeletal Muscle Function

Sarcopenia Clinical Trial

Official title:

Carnitine Supplementation and Skeletal Muscle Function in Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692235
• Other study ID #: 2014/15/B/NZ7/00893
• Status: Completed
• Phase: Phase 3
• Start date: February 2016
• Est. completion date: July 2017

Study information

• Verified date: May 2019
• Source: Gdansk University of Physical Education and Sport
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• carnitine
1500 mg/d l-carnitine-l-tartrate
• placebo
isonitrogenous

Locations

Country	Name	City	State
Poland	University of Physical Education and Sport	Gdansk	Pomorskie

Sponsors (2)

Lead Sponsor	Collaborator
Gdansk University of Physical Education and Sport	National Science Centre, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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