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Completed Phase 1Phase 2 Interventional Accepts healthy volunteers

L-citrulline Supplementation & Cold Exposure

ClinicalTrials.gov ID: NCT01462591

Public ClinicalTrials.gov record NCT01462591. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 1:45 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Effects L-citrulline Supplementation on Arterial Stiffness, Wave Reflection, and Cardiac Autonomic Responses to Cold Exposure With Isometric Exercise

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 exposure. However the potential cardioprotective effects of L-citrulline supplementation during cold exposure with exercise have yet to be evaluated. It is hypothesized that L-citrulline supplementation would reduce arterial stiffness and blood pressure (BP) responses to physiological stress (cold exposure). This study may lead to the development of an adjunct therapy for the prevention and management of cardiovascular adverse events that are particularly increased during the winter months.

Study identification

NCT ID
NCT01462591
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Florida State University
Other
Enrollment
16 participants

Conditions and interventions

Conditions

Interventions

Dietary Supplement

Eligibility (public fields only)

Age range
18 Years to 35 Years
Sex
Male
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2011
Primary completion
Nov 30, 2011
Completion
Apr 30, 2012
Last update posted
Aug 4, 2014

2011 – 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
FSU College of Human Sciences Tallahassee Florida 32306

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01462591, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 4, 2014 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01462591 live on ClinicalTrials.gov.

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