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 range18 Years – 60 Years

SexALL

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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

What they're measuring

Plasma Dopa 1 hr After Breakfast

Timeframe: Plasma samples collected 1 hour after breakfast on both study days.

Urinary Dopa

Timeframe: 4-8 hours after breakfast

Urinary Sodium

Timeframe: 4 to 8 hours after breakfast

Trial details

NCT IDNCT01064739

SponsorVanderbilt University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-09

Results submitted2013-03-01