Carnitine Supplementation and Skeletal Muscle Mass
ROM
2 other identifiers
interventional
24
0 countries
N/A
Brief Summary
The primary aim of the current research project is to investigate the effect of carnitine supplementation on muscle strength and body composition. A secondary aim of this project is to explore the effect of circulating trimethylamine N-oxide elevation, induced by carnitine supplementation on muscle strength and body composition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
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
November 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2017
CompletedFirst Submitted
Initial submission to the registry
August 5, 2021
CompletedFirst Posted
Study publicly available on registry
August 17, 2021
CompletedAugust 17, 2021
August 1, 2021
9 months
August 5, 2021
August 11, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Muscle Strength using Biodex System 4 Pro dynamometer
Peak torque measured by performing maximum voluntary contractions during isometric knee extension and flexion. The test performed in concentric-concentric mode consisting maximum 4-s knee extensor isometric contraction and maximum 4-s knee flexor isometric contraction, separated by 20-s recovery, repeated three times. Muscle isokinetic strength assessed in 5 repetitions of flexion and extension at a speed of 60°/s. Muscle endurance assessed in 10 repetitions at 300°/s determine the ability of the muscle to maintain the work. Strength testing performed on the Biodex System 4 Pro dynamometer.
24 weeks
Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720)
The InBody720 measures impedance of five segments of the body (each arm, each leg, trunk) at frequencies of 1, 5, 50, 250, 500, and 1000 kHz through the 8-polar tactile-electrode. Based on the impedance, body fat mass, fat free mass, and skeletal muscle mass are calculated.
24 weeks
Secondary Outcomes (1)
Plasma trimethylamine N-oxide concentration
24 weeks
Study Arms (3)
carnitine2
EXPERIMENTAL2000 mg L-carnitine per day for 24 weeks
carnitine
ACTIVE COMPARATOR1000 mg L-carnitine per day for 24 weeks
control
NO INTERVENTIONno supplementation
Interventions
Eligibility Criteria
You may qualify if:
- must be able to swallow tablets
You may not qualify if:
- cardiovascular disease
- liver disease
- kidney disease
- neuromuscular disease
- gastrointestinal disorders (including stomach ulcers and erosions)
- diabetes
- other severe chronic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 5, 2021
First Posted
August 17, 2021
Study Start
November 15, 2015
Primary Completion
July 31, 2016
Study Completion
July 31, 2017
Last Updated
August 17, 2021
Record last verified: 2021-08