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NCT01462591 · ClinicalTrials.gov registry record · Phase 1

L-citrulline Supplementation & Cold Exposure

A Phase 1 study, sponsored by Florida State University.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT01462591 is a Phase 1 study that has completed, run by Florida State University. The registered enrollment target is 16 participants.

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The verdict

NCT01462591, a Phase 1 study, has completed, sponsored by Florida State University.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

Cardiovascular disease (CVD) is considered the primary cause of death in the developed world. Large scale epidemiological studies indicate that prevalence of hypertension along with adverse cardiovascular events peak during the winter months. Moreover, during the winter months outdoor activities and physical stressors such as exercise have been associated with higher cardiovascular mortality when compared to other periods of the year. Although low environmental temperatures have been implicated as the triggering factor for cardiovascular complications, the mechanisms on how cold exposure increase cardiovascular morbidity and mortality remain to be elucidated. However, new research suggests that cold exposure may induce increases in cardiac sympathetic activity, endothelial damage and increased arterial stiffness of central arteries. Cardiovascular drugs including antihypertensive pharmacological agents seem to be inefficient to provide appropriate therapeutic effects during cold exposure. Therefore, it is imperative to propose alternative non-pharmacological therapies intended to prevent the detrimental effects of low environmental temperatures on cardiovascular function. Recently, oral supplementation of the amino acid L-citrulline has been proposed as an effective therapeutic adjuvant for the treatment of hypertension. L-citrulline is known to enhance the bioavailability of L-arginine levels and increase endothelial nitric oxide (NO) production, one of the main modulators of vascular tone and blood pressure (BP). L-citrulline supplementation has been shown to increase endothelial function, reduce BP, and ameliorate endothelial oxidative damage without any adverse effects. Our group has demonstrated that L-citrulline supplementation attenuates the BP response to cold exposure (the cold pressor test, CPT). These studies suggest that L-citrulline supplementation may be a feasible therapeutic aid in order to prevent cardiovascular complications associated with cold ex

Interventions

  • DIETARY_SUPPLEMENT L-citrulline

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2011-05
Est. Completion 2012-05
Phase Phase 1

Sponsor

Florida State University

219 total trials

What the Registry Record Tells You About NCT01462591

The ClinicalTrials.gov registry entry for NCT01462591 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida State University, which has 219 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which L-citrulline is the first listed.

NCT01462591 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01462591 about?

NCT01462591 is a clinical study titled "L-citrulline Supplementation & Cold Exposure". Cardiovascular disease (CVD) is considered the primary cause of death in the developed world. Large scale epidemiological studies indicate that prevalence of hypertension along with adverse cardiovascular events peak during the winter months. Moreover, during the winter months outdoor activities and...

What is the current status of trial NCT01462591?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2011-05. Estimated completion is 2012-05.

What interventions are being tested in trial NCT01462591?

The interventions under investigation include: L-citrulline (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01462591?

This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.