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NCT01064739 · ClinicalTrials.gov registry record · Early Phase 1
Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration
A Early Phase 1 study of Healthy Participants, sponsored by Vanderbilt University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT01064739: Completed Early Phase 1 study of Healthy Participants, sponsored by Vanderbilt University.
NCT01064739 is a Early Phase 1 study of Healthy Participants that has completed, run by Vanderbilt University. The registered enrollment target is 14 participants, below the 66-participant average among 119 other Healthy Participants trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01064739, a Early Phase 1 study of Healthy Participants, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylgly
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Fava beans
- OTHER Fixed Sodium Diet
Study Locations (1)
Tennessee
- Vanderbilt University Clinical Research Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2007-01 |
| Est. Completion | 2012-12 |
| Phase | Early Phase 1 |
What the finished NCT01064739 record still lists
NCT01064739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 66-participant average among 119 other Healthy Participants trials with a reported enrollment target (79% lower).
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.
NCT01064739 reports a single indexed study location in Tennessee.
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.
What interventions are being tested in trial NCT01064739?
The interventions under investigation include: Fava beans (DIETARY_SUPPLEMENT), Fixed Sodium Diet (OTHER).
Who is sponsoring clinical trial NCT01064739?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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.
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Where NCT01064739's enrollment target sits among peer trials
14 107th of 119 higher than 11 of 119 other Healthy Participants trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Participants 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.
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