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Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery
Plain-language guide to NCT02635594: not phased randomized trial of L-Carnitine, 36 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02635594
- Phase
- not phased
- Status
- completed
- Start
- 2015-12
- Completion (planned or actual)
- 2016-06
- Participants
- 36 (actual)
- Design
- randomized, quadruple-blind
- Conditions studied
- Healthy Volunteers; Recovery; Endothelial Function
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around L-Carnitine.
Investigation of 4 weeks supplementation with Carnipure® tartrate on endothelial function and parameters of recovery after physical exertion.
It had two arms (groups): Carnipure® tartrate (experimental) and Placebo (placebo comparator).
The registry classes the interventions as dietary supplement and other.
Who Took Part
36 actual participants took part.
It was open to people of any sex aged from 25 years up to 45 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Healthy men and women between 25 and 45 years. Body mass index (BMI) between 20 and 30 kg/m². Physically active 1-2 times per week.
The full record lists 4 inclusion and 21 exclusion criteria; among the exclusions: competitive athlete or performance of high intensity training; nutrition with high portion of meat (\> 3 times meat per week); injury at the finger.
How the Study Was Run
Design: randomized, crossover and quadruple-blind.
The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.
In the crossover set-up each of the participants took both L-Carnitine and the comparison in turn, acting as their own control.
Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2015-12 with completion listed for 2016-06.
It ran at 1 site in Germany.
What Was Measured
Primary outcome: postprandial endothelial function (time frame: after 4 weeks supplementation).
It also tracked 5 secondary outcomes, for example Maximal strength (Nm) before and after exhaustive exercise, pain before and after exhaustive exercise (VAS), Creatin Kinase (CK) before and after exhaustive exercise, Myoglobine (Mb) before and after exhaustive exercise and Biomarker for vascular health.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of L-Carnitine in 36 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.