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Carnitine Supplementation and Bone Mineral Density

Plain-language guide to NCT05120011: not phased randomized trial of L-Carnitine, osteoporosis and bone density, 36 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05120011
Phase
not phased
Status
completed
Start
2017-09-01
Completion (planned or actual)
2018-07-07
Participants
36 (actual)
Design
randomized, double-blind, prevention
Conditions studied
Osteoporosis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested L-Carnitine for osteoporosis and bone density.

A secondary aim of this project is to investigate the effect of supplementation on body composition and blood markers.

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

The registry classes the interventions as dietary supplement.

More on the Plan

The study includes postmenopausal women.

The subjects participate in resistance training (twice a week) 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.

During the 24-weeks training programme participants are supplemented by carnitine with leucine, or leucine alone (placebo).

Who Took Part

The registry lists 36 actual participants took part.

It was open to women only aged from 60 years up to 75 years.

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

Examples of who could join: Lack of restrictions to perform resistance exercises.

The full record lists 2 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.

Groups ran in parallel: each of the osteoporosis and bone density participants stayed in one arm throughout.

Neither the osteoporosis and bone density participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2017-09-01 with completion listed for 2018-07-07.

It ran at 1 site in Poland.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Bone Mineral Density measured by dual-energy X-ray absorptiometry (DXA) (time frame: 24 weeks).

It also tracked 2 secondary outcomes, for example Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720) and The circulating markers modification.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 36 people with osteoporosis and bone density.

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, Osteoporosis and bone density research.

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.