Overview

This trial is active, not recruiting.

Condition sarcopenia
Treatments carnitine, leucine, carnitine & leucine
Phase phase 2/phase 3
Sponsor Gdansk University of Physical Education and Sport
Start date February 2016
End date November 2016
Trial size 40 participants
Trial identifier NCT02692235, 2014/15/B/NZ7/00893

Summary

Research project objectives

The primary aims of the current research project are:

1. To investigate the effects of carnitine with leucine supplementation, in comparison to carnitine supplementation alone, on muscle strength and body composition;

2. To use carnitine supplementation as the anti-inflammatory intervention for exploring the relationship between inflammation and associated with aging reduction of skeletal muscle mass;

3. To explore whether nutritional supplementation and resistance training might be combined to produce synergistic effects in prevention of muscle loss during aging;

Hypothesis

1. Leucine stimulates carnitine transport into the muscle cells, which improve mitochondrial capacity. Modification in energetic of skeletal muscle affects the body composition and muscle performance;

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

3. Resistance training combined with nutritional supplementation have more beneficial effect than resistance training alone in prevention of muscle loss during aging;

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
24 weeks l-carnitine-l-tartrate supplementation
carnitine
1000 mg/d l-carnitine-l-tartrate
(Placebo Comparator)
24 weeks l-leucine supplementation
leucine
1000 mg/d l-leucine
(Other)
24 weeks of l-carnitine-l-tartrate in combination with l-leucine supplementation
carnitine & leucine
500 mg/d l-carnitine-l-tartrate and 500 mg/d l-leucine

Primary Outcomes

Measure
Blood inflammatory markers
time frame: baseline and 24 weeks

Secondary Outcomes

Measure
Metabolism
time frame: baseline and 24 weeks
Carnitine transport to skeletal muscle cells
time frame: baseline and 24 weeks

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

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.

Additional Information

Official title Carnitine Supplementation and Skeletal Muscle Function in Aging
Principal investigator Robert A Olek, PhD
Description The project is separated on two studies. Study A: young volunteers (n=40) are supplemented either with carnitine with leucine or carnitine alone for 24 weeks. Before the start, in the mid-point, and after finishing the supplementation the following primary outputs variables are performed: maximal isokinetic knee extensor peak torque (Biodex System 4 Pro), body composition analysis (InBody720), skeletal muscle carnitine concentration, oral glucose tolerance test. Study B: 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, blood cytokines and carnitine concentration, blood lipid profile and global physical activity questionnaire.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Gdansk University of Physical Education and Sport.