CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 14 enrolled
Drug / intervention
Fava beans +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01064739
NCT01064739Early Ph 1Completed

Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration

Vanderbilt University·interventional·Posted Feb 8, 2010·Updated May 26, 2016

In Brief

A Early Phase 1 clinical trial evaluating Fava beans and Fixed Sodium Diet for Healthy Participants. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2010
Enrollment StartJan 1, 2007
Primary CompletionSep 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 16.4 years ago

Interventions

Fava beansdietary

Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet

Fixed Sodium Dietother

Fixed sodium low monoamine diet