Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function

NCT ID: NCT03907592

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-07-07

Brief 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.

Detailed 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.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

L-carnitine Group

Group participated in the training protocol and supplemented by 1000 mg L-carnitine-L-tartrate in combination with 3000 mg L-leucine per day throughout 24 weeks.

Group Type: EXPERIMENTAL

L-carnitine supplementation

Intervention Type: DIETARY_SUPPLEMENT

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

Resistance training

Intervention Type: PROCEDURE

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

Leucine Group

Group participated in the training protocol and supplemented by 4000mg of L-leucine per day throughout 24 weeks.

Group Type: EXPERIMENTAL

Leucine supplementation

Intervention Type: DIETARY_SUPPLEMENT

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

Resistance training

Intervention Type: PROCEDURE

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

Control Group

Group participated in the training protocol without any supplementation throughout 24 weeks.

Group Type: EXPERIMENTAL

Resistance training

Intervention Type: PROCEDURE

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

Interventions

L-carnitine supplementation

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

Intervention Type: DIETARY_SUPPLEMENT

Leucine supplementation

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

Intervention Type: DIETARY_SUPPLEMENT

Resistance training

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Gdansk

OTHER

Sponsor Role: collaborator

National Science Centre, Poland

OTHER_GOV

Sponsor Role: collaborator

Gdansk University of Physical Education and Sport

OTHER

Sponsor Role: lead

Responsible Party

Robert Olek

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert A Olek, PhD

Role: PRINCIPAL_INVESTIGATOR

Gdansk University of Physical Education and Sport

Locations

University of Physical Education and Sport

Gdansk, Pomeranian Voivodeship, Poland

Countries

Poland

Other Identifiers

DSRiK/10/2017

Identifier Type: -

Identifier Source: org_study_id