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NCT02104375 · ClinicalTrials.gov registry record · Phase 1
L-citrulline Supplementation, Cold Exposure, & Post-Exercise Muscle Ischemia
A Phase 1 study of Hypertension, sponsored by Florida State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT02104375: Completed Phase 1 study of Hypertension, sponsored by Florida State University.
NCT02104375 is a Phase 1 study of Hypertension that has completed, run by Florida State University. The registered enrollment target is 16 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02104375, a Phase 1 study of Hypertension, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Cardiovascular disease (CVD) continues to be the major cause of morbidity and mortality in western countries. It has been shown that CVD events are known to be higher in the winter than in the summer. Low environmental temperatures may induce increased cardiovascular stress resulting in cold-induced hypertension (CIH), the leading risk factor for CVD events. Similar to whole-body cold exposure, the cold pressor test (CPT), an external local cold stimulus, has been used for evaluation of cardiovascular and hemodynamic reactivity to sympathetic stimulation. It has been shown that brachial blood pressure (BP), pressure pulse wave reflection, aortic BP, heart rate (HR), and arterial stiffness are increased during CPT. However, the physiologic mechanisms for the cardiovascular complications related to low temperatures are not completely clear. Isometric-handgrip (IHG) exercise has been used as a tool for assessing cardiovascular autonomic control by a maneuver defined as post-exercise muscle ischemia (PEMI). PEMI induces exercise pressor reflex (metaboreflex) by trapping metabolites in the previous active muscle at the cessation of exercise. During PEMI, the accumulation of contraction-derived metabolites induces sympathetic mediated vascular stimulation and an increased BP, whereas the HR fully recovers. This suggests that the fall in HR is evoked by an increase in parasympathetic activity which overpowers the sympathetic activation. Implication of IHG exercise followed by PEMI provides important clinical information because impaired autonomic and cardiovascular functions are associated with cardiovascular events. Recently, oral supplementation with the amino acid L-citrulline (L-cit) has been proposed as a possible adjunct treatment for hypertension and arterial stiffness. L-cit is known to enhance the bioavailability of L-arginine (L-arg), the endothelial substrate for nitric oxide (NO) production. Cold exposure might include a temperature-dependent inhibition of en
Primary Outcome
By measuring brachial and central (aortic and carotid) BP at rest and during physiological stress (cold pressor test, post-exercise muscle ischemia, and handgrip test)
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT L-citrulline
Study Locations (1)
Florida
- FSU College of Human Sciences - Tallahassee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT02104375 record still lists
NCT02104375 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 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which L-citrulline is the first listed.
NCT02104375 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02104375 about?
NCT02104375 is a clinical study titled "L-citrulline Supplementation, Cold Exposure, & Post-Exercise Muscle Ischemia". Cardiovascular disease (CVD) continues to be the major cause of morbidity and mortality in western countries. It has been shown that CVD events are known to be higher in the winter than in the summer. Low environmental temperatures may induce increased cardiovascular stress resulting in cold-induced...
What is the current status of trial NCT02104375?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2013-03. Estimated completion is 2014-12.
What conditions does trial NCT02104375 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT02104375?
The interventions under investigation include: L-citrulline (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02104375?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02104375 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02104375's enrollment target sits among peer trials
16 451st of 470 higher than 19 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension 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.
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