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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: Completed Phase 1 study, sponsored by Florida State University.
NCT01462591 is a Phase 1 study that has completed, run by Florida State University. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
By measuring brachial and central (aortic and carotid) BP at rest and during physiological stress (cold exposure and handgrip test)
Interventions
- DIETARY_SUPPLEMENT L-citrulline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
What the finished NCT01462591 record still lists
NCT01462591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which L-citrulline is the first listed.
NCT01462591 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01462591's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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