Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2018
CompletedFirst Submitted
Initial submission to the registry
April 6, 2019
CompletedFirst Posted
Study publicly available on registry
April 9, 2019
CompletedApril 10, 2019
April 1, 2019
10 months
April 6, 2019
April 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Changes in the strength of muscle knee extensor
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
Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.
Study Arms (3)
L-carnitine Group
EXPERIMENTALGroup 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.
Leucine Group
EXPERIMENTALGroup participated in the training protocol and supplemented by 4000mg of L-leucine per day throughout 24 weeks.
Control Group
EXPERIMENTALGroup participated in the training protocol without any supplementation throughout 24 weeks.
Interventions
Supplementation of 1000 mg L-carnitine-L-tartrate in combination with 3000 mg L-leucine per day throughout the study period.
Supplementation of 4000 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).
Eligibility Criteria
You may qualify if:
- aged-matched, no chronic disease, doctor's note about the lack of restrictions to perform resistance exercises
You may not qualify if:
- diabetes, liver, heart and renal diseases, gastric problems, as well as using the vitamin supplements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gdansk University of Physical Education and Sportlead
- Medical University of Gdanskcollaborator
- National Science Centre, Polandcollaborator
Study Sites (1)
University of Physical Education and Sport
Gdansk, Pomeranian Voivodeship, 80-336, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert A Olek, PhD
Gdansk University of Physical Education and Sport
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 6, 2019
First Posted
April 9, 2019
Study Start
September 1, 2017
Primary Completion
July 7, 2018
Study Completion
July 7, 2018
Last Updated
April 10, 2019
Record last verified: 2019-04