Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration (NCT01064739) | Clinical Trial Compass
CompletedEarly Phase 1
Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration
United States14 participantsStarted 2007-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Non-smoking
* Free of medications with the potential to influence BP
* Age between 18-60 years
* Male and female subjects are eligible
* Able and willing to provide informed consent
Exclusion Criteria:
* Significant cardiovascular, pulmonary, hepatic, or hematological disease by history or screening results
* Positive urine b-hcg pregnancy test
* Evidence of cardiac structural disease (by clinical examination or prior echocardiogram)
* Hypertension defined as a BP\>145/95 (off medications) or need for antihypertensive medications
* Evidence of significant conduction system delay (QRS duration \>120 ms) on electrocardiogram
* Inability to give, or withdraw, informed consent
* Other factors which in the investigator's opinion would prevent the subject from completing the protocol Food allergies to favas or other dietary dopa sources selected
* Parkinson's Disease
* Diagnosis of Glucose-6-Phosphate Dehydrogenase (G6P) Deficiency or Individuals from the Mediterranean with family history of G6PD.
* Prolonged QT interval on ECG\> 480 13. Familial history of sudden cardiac death
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma Dopa 1 hr After Breakfast
Timeframe: Plasma samples collected 1 hour after breakfast on both study days.