- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03907592
Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function
Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function in Aging
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pomorskie
-
Gdansk, Pomorskie, Poland, 80-336
- University of Physical Education and Sport
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Supplementation of 1000 mg L-carnitine-L-tartrate in combination with 3000 mg L-leucine per day throughout the study period.
Resistance training at the gym, twice a week for 24 weeks (48 training units in total).
|
Experimental: Leucine Group
Group participated in the training protocol and supplemented by 4000mg of L-leucine per day throughout 24 weeks.
|
Resistance training at the gym, twice a week for 24 weeks (48 training units in total).
Supplementation of 4000 mg L-leucine per day throughout the study period.
|
Experimental: Control Group
Group participated in the training protocol without any supplementation throughout 24 weeks.
|
Resistance training at the gym, twice a week for 24 weeks (48 training units in total).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.
|
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).
|
Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSRiK/10/2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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