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The Effect of Leucine on Carnitine Transport to Skeletal Muscle

Plain-language guide to NCT05009654: not phased randomized trial of L-Carnitine, 16 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05009654
Phase
not phased
Status
completed
Start
2016-10-01
Completion (planned or actual)
2017-05-15
Participants
16 (actual)
Design
randomized, double-blind, prevention
Conditions studied
Muscle Loss
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around L-Carnitine.

A secondary aim of this project is to investigate the effect of carnitine with leucine supplementation on muscle strength and body composition.

It had two arms (groups): carnitine + leucine (experimental) and leucine (placebo comparator).

The registry classes the interventions as dietary supplement.

Who Took Part

16 actual participants took part.

It was open to people of any sex aged from 18 years up to 29 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Must be able to swallow tablets.

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: cardiovascular disease; liver disease; kidney disease.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant and investigator.

It started in 2016-10-01 with completion listed for 2017-05-15.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Muscle Carnitine Concentration using UPLC-MS/MS (time frame: 24 weeks).

It also tracked 2 secondary outcomes, for example Muscle Strength using Biodex System 4 Pro dynamometer and Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 16 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.

Our Notes on the Compound

L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.