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Effect of the Administration of L-Carnitine on Body Weight in Women in Crossfit Training
Plain-language guide to NCT03436277: phase 2 randomized trial of L-Carnitine, 24 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03436277
- Phase
- phase 2
- Status
- status unknown
- Start
- 2018-12-17
- Completion (planned or actual)
- 2019-02
- Participants
- 24 (estimated)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Body Weight Changes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested L-Carnitine.
It had two arms (groups): Placebo (placebo comparator) and L-Carnitine (experimental).
The registry classes the interventions as dietary supplement and drug.
More on the Plan
A randomized, double-blind, placebo-controlled clinical trial will be carry out in 24 woman with body mass index ≥ 25 to 29.9 kg/m2.
Before and after intervention the investigators evaluate: The body composition (body fat, lean body mass), arm muscle circumference, waist circumference, body weight and body mass index.
Who Took Part
Enrollment: 24 planned participants were the target.
It was open to women only aged from 18 years up to 40 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Volunteers who practice crossfit regularly (who have 3 months prior to the beginning of the study practicing crossfit). Volunteers with a body mass index equal to or greater than 25 Kg/m2. Volunteers who do not have allergies to L-Carnitine or any of its components. Informed consent signed. Women with a recommendation of nutrition two weeks prior to the start of the study.
The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: volunteers with pathologies such as diabetes, hypertension, metabolic syndrome and allergies; women with confirmed or suspected pregnancy; women under lactation and/or puerperium.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
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 2018-12-17 with completion listed for 2019-02.
It ran at 1 site in Mexico.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Body Fat (time frame: 8 weeks). Lean body mass (time frame: 8 weeks). Body Weight (time frame: 8 weeks).
It also tracked 3 secondary outcomes, for example Arm muscle circumference, Waist circumference and Body Mass Index.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of L-Carnitine in 24 people.
Its size is small, so on its own it can only give an early look.
Its status is unknown; 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.