Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Completed Phase 1 study, sponsored by Florida State University.

NCT01185041 is a Phase 1 study that has completed, run by Florida State University. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Primary Outcome

By measuring brachial and central (aortic and carotid) BP at rest and during physiological stress (head-up tilt test and cold pressor test)

Interventions

  • DIETARY_SUPPLEMENT Watermelon Extract

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2010-08
Est. Completion 2011-08
Phase Phase 1
Florida State University

219 total trials

What the finished NCT01185041 record still lists

NCT01185041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 1 intervention - of which Watermelon Extract is the first listed.

NCT01185041 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01185041's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00573339 · 20 participants

    Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing

  • NCT00692939 · 20 participants · Phase 1

    Autologous Stem Cell Transplantation for Crohn's Disease

  • NCT00967785 · 20 participants · Phase 1

    A Phase I Study of Mozobil in the Treatment of Patients With WHIMS

  • NCT01406691 · 20 participants · Phase 4

    Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01185041, the US trial registry maintained by the National Library of Medicine. NCT01185041 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.