Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration
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Purpose
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:
- To determine the effect of dietary dopa sources on plasma and urinary catecholamines.
- To investigate the capacity of botanical dopaminergic agents (fava beans) to induce natriuresis in a short term study.
- 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Biological: Fava beans |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration |
- Plasma dopa, urinary dopamine, urinary sodium [ Time Frame: Plasma samples collected before breakfast and 1, 2, 4 and 6 hours after breakfast on both study days. Urine collected 0-4, 4-8, and 8-12 hours after breakfast on both study days.f inpatient study days ] [ Designated as safety issue: No ]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. Three consecutive 4- hr urine samples were collected for electrolyte and catechol content.
- Other plasma catechols (norepinephrine, dopamine) [ Time Frame: Before and 1, 2, 4 and 6 hours after breakfast on both study days. ] [ Designated as safety issue: No ]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.
- Other urinary catechols (dopa, norepinephrine) [ Time Frame: 0-4, 4-8, and 8-12 hours after breakfast on both study days. ] [ Designated as safety issue: No ]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). Three consecutive 4- hr urine samples were collected for electrolyte and catechol content.
- Blood pressure and heart rate [ Time Frame: Supine-before breakfast and 1, 2, 4 and 6 hours after breakfast on both study days. Upright-2 and 6 hours after breakfast on both study days. ] [ Designated as safety issue: No ]
In the morning (0700h), while still supine after the overnight sleep, HR and BP will be recorded. Supine HR and BP will be measured by Dinamap at 0900, 1000, 1200 (before the meal), and 1400hr.
In addition, at 1000 and 1400hr, subjects will stand for 30 minutes for upright BP and HR measurements
| Enrollment: | 14 |
| Study Start Date: | January 2007 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fava beans
A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
|
Biological: Fava beans
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
|
Detailed Description:
Fava beans are a broad bean, with potential clinical relevance in Parkinson's patients since they contain high levels of the dopamine precursor, dihydroxyphenylalanine (dopa).In addition to the central nervous system functions of dopamine that are compromised in Parkinson's disease, renal dopamine has vasodilatory and natriuretic activity. Elevated urinary dopamine, however, does not consistently correlate with increased urinary sodium excretion, and there are conflicting opinions over the conditions under which renal dopamine might regulate sodium balance.The goal of our study was to clarify the natriuretic effect of fava beans, obtained from a source that serves patients with Parkinson's disease. Catechol and sodium data were compared in healthy volunteers using a longitudinal design in which all participants consumed a fixed sodium study diet on day 1 and the fixed sodium diet plus fava beans on day 2. Blood was sampled at 1, 2, 4 and 6 hours after breakfast, and three consecutive 4-hr urine samples were collected.
Postural tachycardia syndrome (POTS) is the most common form of orthostatic intolerance, affecting an estimated 500,000 Americans, principally young women. POTS refers to an excessive increase in heart rate (>30 beats per minute) on standing in the absence of orthostatic hypotension. Previous findings by the Robertson/Garland research group suggest that mechanisms involved in orthostatic and absolute volume regulation contribute to POTS pathophysiology. A follow-up study might compare the influences of diet in patients with POTS and healthy volunteers.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Emily M. Garland, Research Associate Professor, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT01064739 History of Changes |
| Other Study ID Numbers: | PN 1767 |
| Study First Received: | February 5, 2010 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
Healthy Volunteers Fava bean consumption L-Dopa content in Fava Beans Sodium |
Potassium Electrolyte Balance Natriuresis |
Additional relevant MeSH terms:
|
Tachycardia Postural Orthostatic Tachycardia Syndrome Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Orthostatic Intolerance Primary Dysautonomias |
Autonomic Nervous System Diseases Nervous System Diseases Dihydroxyphenylalanine Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013