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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 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.

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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

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT L-citrulline

Study Locations (1)

Florida

  • FSU College of Human Sciences - Tallahassee

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2013-03
Est. Completion 2014-12
Phase Phase 1

Sponsor

Florida State University

219 total trials

What the Registry Record Tells You About NCT02104375

The ClinicalTrials.gov registry entry for NCT02104375 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (100% lower). The listed sponsor is Florida State University, which has 219 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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