Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03907592
• Other study ID #: DSRiK/10/2017
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 7, 2018

Study information

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

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 7, 2018
• Est. primary completion date: July 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• L-carnitine supplementation
Supplementation of 1000 mg L-carnitine-L-tartrate in combination with 3000 mg L-leucine per day throughout the study period.
• Leucine supplementation
Supplementation of 4000 mg L-leucine per day throughout the study period.

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

Locations

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

Sponsors (3)

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

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volumetric changes in knee extensor muscle	Volumetric examination of cross section area (CSA) of knee extensor muscles determined by a 1.5 T MRI scanner.	Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.
Secondary	Changes in the strength of muscle knee extensor	Maximal isometric knee extensor peak torques determined by the dynamometer (Biodex System 4 Pro).	Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.
Secondary	Changes in Lean Body Mass	Lean Body Mass measured by dual-energy X-ray absorptiometry (DXA).	Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.