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Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
L-carnitine supplementation
Leucine supplementation
Resistance training
Sponsored by
Gdansk University of Physical Education and Sport
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring L-Carnitine, Resistance training, Magnetic resonance imaging, Muscle function, Aging, Leucine

Eligibility Criteria

60 Years - 72 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Physical Education and Sport

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

L-carnitine Group

Leucine Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in the strength of muscle knee extensor
Maximal isometric knee extensor peak torques determined by the dynamometer (Biodex System 4 Pro).
Changes in Lean Body Mass
Lean Body Mass measured by dual-energy X-ray absorptiometry (DXA).

Full Information

First Posted
April 6, 2019
Last Updated
April 8, 2019
Sponsor
Gdansk University of Physical Education and Sport
Collaborators
Medical University of Gdansk, National Science Centre, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT03907592
Brief Title
Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function
Official Title
Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function in Aging
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
July 7, 2018 (Actual)
Study Completion Date
July 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gdansk University of Physical Education and Sport
Collaborators
Medical University of Gdansk, National Science Centre, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
L-Carnitine, Resistance training, Magnetic resonance imaging, Muscle function, Aging, Leucine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L-carnitine Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Leucine Group
Arm Type
Experimental
Arm Description
Group participated in the training protocol and supplemented by 4000mg of L-leucine per day throughout 24 weeks.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Group participated in the training protocol without any supplementation throughout 24 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
L-carnitine supplementation
Intervention Description
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
Intervention Name(s)
Leucine supplementation
Intervention Description
Supplementation of 4000 mg L-leucine per day throughout the study period.
Intervention Type
Procedure
Intervention Name(s)
Resistance training
Intervention Description
Resistance training at the gym, twice a week for 24 weeks (48 training units in total).
Primary Outcome Measure Information:
Title
Volumetric changes in knee extensor muscle
Description
Volumetric examination of cross section area (CSA) of knee extensor muscles determined by a 1.5 T MRI scanner.
Time Frame
Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.
Secondary Outcome Measure Information:
Title
Changes in the strength of muscle knee extensor
Description
Maximal isometric knee extensor peak torques determined by the dynamometer (Biodex System 4 Pro).
Time Frame
Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.
Title
Changes in Lean Body Mass
Description
Lean Body Mass measured by dual-energy X-ray absorptiometry (DXA).
Time Frame
Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Olek, PhD
Organizational Affiliation
Gdansk University of Physical Education and Sport
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Physical Education and Sport
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-336
Country
Poland

12. IPD Sharing Statement

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Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function

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