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L-citrulline Supplementation, Cold Exposure, & Post-Exercise Muscle Ischemia
NCT02104375 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02104375
The ClinicalTrials.gov registry entry for NCT02104375 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 291 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02104375 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02104375?
The interventions under investigation include: L-citrulline (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02104375?
This trial is sponsored by Florida State University, which has 291 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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