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NCT Number: NCT03907592

Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function

The primary aim of the current research project is to explore whether nutritional supplementation and resistance training might be combined to produce synergistic effects in the prevention of muscle loss during aging.

A secondary aim of this project is to investigate the effects of carnitine with leucine supplementation, in comparison to carnitine supplementation alone, on muscle strength and body composition.

The hypothesis is that resistance training combined with nutritional supplementation have a more beneficial effect than resistance training alone in the prevention of muscle loss during aging. 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.

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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

60 year–72 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Physical Education and Sport

Gdansk, Pomeranian Voivodeship, 80-336, Poland

About this study

The study will be included volunteers - women between 60 - 72 years old (n=60). The patients are randomly assigned to two experimental groups (n=20) and control group (n=20). During the 24-weeks intervention period, Group A undergoes training procedure supplemented with the carnitine and leucine, whilst group B undergoes training procedure supplemented with leucine. At the same time control group go through only training procedure. Measurements are performed before, at the mid-point, and at the end of the intervention period.

Approximately 1 week prior to the experimental trial day, participants perform a familiarization session during which one-repetition maximum (1RM) strength testing is also performed to determine the experimental exercise load. Resistance exercise training is performed twice weekly on non-consecutive days (Monday+Thursday, or Tuesday+Friday) for 24-weeks under direct supervision by a research assistant. Prior to a training session subjects are required to perform warm - up on the treadmill (walk) and static stretching, after each session - cool down on the cycle ergometer and static stretching. Resistance exercise for each session consisted of 6 exercises: horizontal seated leg press, seated chest press, leg extension, shoulder press, lat pull-down seated row, seated cable row First two weeks of training consist of 3 sets of 10-12 repetitions and are keeping exercises at 65% of 1 repetition maximum (1RM). After this period training consists of 3 sets of 6-8 repetitions and is progressing to 80% of 1RM. The 1RM is re-evaluated every 2 weeks, and the training load is adjusted accordingly. The exercise program follows the recommended guidelines for older adults by the American College of Sports Medicine and the National Strength and Conditioning Association.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • aged-matched, no chronic disease, doctor's note about the lack of restrictions to perform resistance exercises

Exclusion criteria

  • diabetes, liver, heart and renal diseases, gastric problems, as well as using the vitamin supplements

Treatment and study plan

L-carnitine supplementation

Dietary Supplement

Supplementation of 1000 mg L-carnitine-L-tartrate in combination with 3000 mg L-leucine per day throughout the study period.

Leucine supplementation

Dietary Supplement

Supplementation of 4000 mg L-leucine per day throughout the study period.

Resistance training

Procedure

Resistance training at the gym, twice a week for 24 weeks (48 training units in total).

Primary outcomes

  1. Volumetric changes in knee extensor muscle

    Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.

    Volumetric examination of cross section area (CSA) of knee extensor muscles determined by a 1.5 T MRI scanner.

Secondary outcomes

  1. Changes in the strength of muscle knee extensor

    Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.

    Maximal isometric knee extensor peak torques determined by the dynamometer (Biodex System 4 Pro).

  2. Changes in Lean Body Mass

    Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.

    Lean Body Mass measured by dual-energy X-ray absorptiometry (DXA).

Sponsors and collaborators

Lead sponsor

Gdansk University of Physical Education and Sport

Other

Collaborators

  • Medical University of Gdansk
  • National Science Centre, Poland

Registry information

Official study title

Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function in Aging

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 9, 2019
Registry last updated
Apr 10, 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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