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NCT01185041 · ClinicalTrials.gov registry record · Phase 1
Watermelon Supplementation and Arterial Stiffness
A Phase 1 study, sponsored by Florida State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01185041 is a Phase 1 study that has completed, run by Florida State University. The registered enrollment target is 20 participants.
The verdict
NCT01185041, a Phase 1 study, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Increased abdominal obesity (waist circumference) and systolic blood pressure (BP) are main risk factors for the metabolic syndrome. Approximately 60% of adults in the United States are prehypertensive or hypertensive. Hypertension has been associated with abnormal endothelial and autonomic function, the two main mechanisms of BP regulation. Endothelial dysfunction, as a result of reduced NO (a vasodilator), and increased sympathetic nervous system activity contribute to arterial stiffness by enhancing the vasomotor tone. Because BP variations are sensed by baroreceptors in the wall of large arteries, increased stiffness of arteries may attenuate the control of BP by the autonomic nervous system leading to hypertension. High production of proinflammatory cytokines and low adiponectin (vascular protective molecule), are considered the underlying mechanisms leading to endothelial dysfunction and arterial stiffness. The recommended intervention for controlling BP in overweight/obese individuals with pre- and stage 1- hypertension is lifestyle modifications and not drug therapy. Among the dietary regimens that are reported to reduce BP is L-arginine, the substrate for endothelial NO production. Recently, oral L-citrulline has been shown to be more effective than L-arginine in improving circulating NO levels because is not affected by enzymatic degradation. Watermelon, the leading US melon crop, is one of the few natural foods rich in L-citrulline which is efficiently transformed to arginine in humans. The investigators long-term goal is to provide feasible and effective dietary ways to reduce cardiovascular risk factors in individuals with high abdominal fat and BP. The overall objective of this study is to bring forth evidence that watermelon supplementation will reduce BP and cardiovascular risk factors such as arterial stiffness, autonomic dysfunction and endothelial dysfunction. The investigators postulate that watermelon supplementation will reduce BP and arterial
Interventions
- DIETARY_SUPPLEMENT Watermelon Extract
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01185041
The ClinicalTrials.gov registry entry for NCT01185041 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 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 Watermelon Extract is the first listed.
NCT01185041 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01185041 about?
NCT01185041 is a clinical study titled "Watermelon Supplementation and Arterial Stiffness". Increased abdominal obesity (waist circumference) and systolic blood pressure (BP) are main risk factors for the metabolic syndrome. Approximately 60% of adults in the United States are prehypertensive or hypertensive. Hypertension has been associated with abnormal endothelial and autonomic function...
What is the current status of trial NCT01185041?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2010-08. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01185041?
The interventions under investigation include: Watermelon Extract (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01185041?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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