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COMPLETED Early Phase 1

Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration

NCT01064739 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to learn how plants can play a role in gain/loss of sodium in the urine and in the regulation of blood pressure. Dopamine is a chemical mostly present in the brain and kidneys which assists in regulation of the body's salts (sodium and potassium). Fava beans contain a lot of the chemical that increases the production of dopamine by the kidneys. The purpose of these studies is to characterize the diuretic effects of dietary catecholamine sources in healthy individuals. Specific aims are: 1. To determine the effect of dietary dopa sources on plasma and urinary catecholamines. 2. To investigate the capacity of botanical dopaminergic agents (fava beans) to induce natriuresis in a short term study. 3. To provide preliminary data on the effects of dietary dopa on heart rate and blood pressure. In these studies, we will test the null hypothesis (Ho) that urinary sodium excretion will not differ in healthy volunteers after consumption of a fixed-sodium study diet and the study diet plus fava beans.

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT Fava beans
  • OTHER Fixed Sodium Diet

Study Locations (1)

Tennessee

  • Vanderbilt University Clinical Research Center — Nashville

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2007-01
Est. Completion 2012-12
Phase Early Phase 1

Sponsor

Vanderbilt University

194 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01064739

The ClinicalTrials.gov registry entry for NCT01064739 describes a study currently listed as completed. It is categorized as Early 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 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 194 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 Healthy Participants appearing as the primary indexed condition, and to 2 interventions — of which Fava beans 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: NCT01064739 reports 1 study location spanning 1 distinct geographic area — top geographies include Tennessee. 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 NCT01064739 about?

NCT01064739 is a clinical study titled "Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration". The purpose of this study is to learn how plants can play a role in gain/loss of sodium in the urine and in the regulation of blood pressure. Dopamine is a chemical mostly present in the brain and kidneys which assists in regulation of the body's salts (sodium and potassium). Fava beans contain a lo...

What is the current status of trial NCT01064739?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 14 participants. The study started on 2007-01. Estimated completion is 2012-12.

What conditions does trial NCT01064739 study?

This clinical trial studies the following conditions: Healthy Participants. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01064739?

The interventions under investigation include: Fava beans (DIETARY_SUPPLEMENT), Fixed Sodium Diet (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01064739?

This trial is sponsored by Vanderbilt University, which has 194 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01064739 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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