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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Diet +/- fava beans | Experimental | Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fava beans | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Dopa 1 hr After Breakfast | 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 (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes. | Plasma samples collected 1 hour after breakfast on both study days. |
| Urinary Dopa | Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes. | 4-8 hours after breakfast |
| Urinary Sodium | Urinary sodium excreted 4-8 hours after breakfast was designated as a primary outcome. Other urine samples (0-4 hr, 8-12 hr after breakfast) are considered as non-primary outcomes. | 4 to 8 hours after breakfast |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Dopa 2 Hrs After Breakfast | 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 (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily M Garland, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Clinical Research Center | Nashville | Tennessee | 37232-2195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23553159 | Derived | Garland EM, Cesar TS, Lonce S, Ferguson MC, Robertson D. An increase in renal dopamine does not stimulate natriuresis after fava bean ingestion. Am J Clin Nutr. 2013 May;97(5):1144-50. doi: 10.3945/ajcn.112.048470. Epub 2013 Apr 3. |
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Participants were recruited in the Nashville, TN area between November, 2009 and November, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fixed Sodium Diet +/- Fava Beans | Participants consumed a fixed sodium diet on day 1 and the same diet plus 100g of fresh fava beans at breakfast and lunch on day 2.The 14 participants received both interventions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fixed Sodium Study Diet |
| |||||||||||||
| Fixed Sodium Diet + Fava Beans |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Dopa 1 hr After Breakfast | 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 (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes. | Posted | Mean | Standard Deviation | pg/mL | Plasma samples collected 1 hour after breakfast on both study days. |
|
2 1/2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| blood in urine | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Garland | Vanderbilt University | 615 936 1748 | emily.garland@vanderbilt.edu |
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| Fixed Sodium Diet | Other | Fixed sodium low monoamine diet |
|
| Plasma samples collected 2 hours after breakfast on both study days. |
| Plasma Dopa 4 Hrs After Breakfast | 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 (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes. | Plasma samples collected 4 hours after breakfast on both study days. |
| Plasma Dopa 6 Hrs After Breakfast | 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 (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes. | Plasma samples collected 6 hours after breakfast on both study days. |
| Plasma Norepinephrine | Plasma norepinephrine 1 hour after breakfast | 1 hour after breakfast on both study days. |
| Plasma Norepinephrine | Plasma norepinephrine 2 hours after breakfast | 2 hours after breakfast on both study days. |
| Plasma Norepinephrine | Plasma norepinephrine 4 hours after breakfast | 4 hours after breakfast on both study days. |
| Plasma Norepinephrine | Plasma norepinephrine 6 hours after breakfast | 6 hours after breakfast on both study days. |
| Plasma Dopamine | Plasma dopamine 1 hour after breakfast | 1 hour after breakfast |
| Plasma Dopamine | Plasma dopamine 2 hours after breakfast | 2 hours after breakfast on both study days. |
| Plasma Dopamine | Plasma dopamine 4 hours after breakfast | 4 hours after breakfast on both study days. |
| Plasma Dopamine | Plasma dopamine 6 hours after breakfast | Plasma samplesPlasma dopamine 6 hours after breakfast on both study days. |
| Urinary Dopa | Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes. | 0-4 hours after breakfast |
| Urinary Dopa | Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes. | 8-12 hours after breakfast |
| Urinary Dopamine | Urinary dopamine excreted 0 to 4 hours after breakfast | 0 to 4 hours after breakfast |
| Urinary Dopamine | Urinary dopamine excreted 4 to 8 hours after breakfast | 4 to 8 hours after breakfast |
| Urinary Dopamine | Urinary dopamine excreted 8 to 12 hours after breakfast | 8 to 12 hours after breakfast |
| Urinary Norepinephrine | Urinary norepinephrine excreted 0-4 hours after breakfast | 0 to 4 hours after breakfast |
| Urinary Norepinephrine | Urinary norepinephrine excreted 4-8 hours after breakfast | 4 to 8 hours after breakfast |
| Urinary Norepinephrine | Urinary norepinephrine excreted 8-12 hours after breakfast | 8 to 12 hours after breakfast |
| Supine Systolic Blood Pressure | Supine systolic blood pressure 6 hours after breakfast | Supine-6 hours after breakfast on both study days. |
| Supine Heart Rate | Supine heart rate 6 hours after breakfast | 6 hours after breakfast |
| Urinary Sodium | Urinary sodium excreted 0-4 hours after breakfast. | 0-4 hours after breakfast |
| Urinary Sodium | urinary sodium 8-12 hours after breakfast | 8-12 hours after breakfast |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Fixed Sodium Study Diet | A study diet with a fixed amount of sodium and no fava beans. |
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| Secondary | Plasma Dopa 2 Hrs After Breakfast | 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 (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes. | Posted | Mean | Standard Deviation | pg/mL | Plasma samples collected 2 hours after breakfast on both study days. |
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| Secondary | Plasma Dopa 4 Hrs After Breakfast | 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 (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes. | Posted | Mean | Standard Deviation | pg/mL | Plasma samples collected 4 hours after breakfast on both study days. |
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| Primary | Urinary Dopa | Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes. | Posted | Mean | Standard Deviation | micrograms/4hr | 4-8 hours after breakfast |
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| Primary | Urinary Sodium | Urinary sodium excreted 4-8 hours after breakfast was designated as a primary outcome. Other urine samples (0-4 hr, 8-12 hr after breakfast) are considered as non-primary outcomes. | Posted | Mean | Standard Deviation | mEq/4 hr | 4 to 8 hours after breakfast |
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| Secondary | Plasma Dopa 6 Hrs After Breakfast | 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 (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes. | Posted | Mean | Standard Deviation | pg/mL | Plasma samples collected 6 hours after breakfast on both study days. |
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| Secondary | Plasma Norepinephrine | Plasma norepinephrine 1 hour after breakfast | Posted | Mean | Standard Deviation | pg/mL | 1 hour after breakfast on both study days. |
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| Secondary | Plasma Norepinephrine | Plasma norepinephrine 2 hours after breakfast | Posted | Mean | Standard Deviation | pg/mL | 2 hours after breakfast on both study days. |
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| Secondary | Plasma Norepinephrine | Plasma norepinephrine 4 hours after breakfast | Posted | Mean | Standard Deviation | pg/mL | 4 hours after breakfast on both study days. |
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| Secondary | Plasma Norepinephrine | Plasma norepinephrine 6 hours after breakfast | Posted | Mean | Standard Deviation | pg/mL | 6 hours after breakfast on both study days. |
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| Secondary | Plasma Dopamine | Plasma dopamine 1 hour after breakfast | Posted | Mean | Standard Deviation | pg/mL | 1 hour after breakfast |
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| Secondary | Plasma Dopamine | Plasma dopamine 2 hours after breakfast | Posted | Mean | Standard Deviation | pg/mL | 2 hours after breakfast on both study days. |
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| Secondary | Plasma Dopamine | Plasma dopamine 4 hours after breakfast | Posted | Mean | Standard Deviation | pg/mL | 4 hours after breakfast on both study days. |
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| Secondary | Plasma Dopamine | Plasma dopamine 6 hours after breakfast | Posted | Mean | Standard Deviation | pg/mL | Plasma samplesPlasma dopamine 6 hours after breakfast on both study days. |
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| Secondary | Urinary Dopa | Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes. | Posted | Mean | Standard Deviation | ug/4hr | 0-4 hours after breakfast |
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| Secondary | Urinary Dopa | Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes. | Posted | Mean | Standard Deviation | micrograms/4hr | 8-12 hours after breakfast |
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| Secondary | Urinary Dopamine | Urinary dopamine excreted 0 to 4 hours after breakfast | Posted | Mean | Standard Deviation | micrograms/4hr | 0 to 4 hours after breakfast |
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| Secondary | Urinary Dopamine | Urinary dopamine excreted 4 to 8 hours after breakfast | Posted | Mean | Standard Deviation | micrograms/4 hours | 4 to 8 hours after breakfast |
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| Secondary | Urinary Dopamine | Urinary dopamine excreted 8 to 12 hours after breakfast | Posted | Mean | Standard Deviation | micrograms/4hr | 8 to 12 hours after breakfast |
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| Secondary | Urinary Norepinephrine | Urinary norepinephrine excreted 0-4 hours after breakfast | Posted | Mean | Standard Deviation | micrograms/4 hours | 0 to 4 hours after breakfast |
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| Secondary | Urinary Norepinephrine | Urinary norepinephrine excreted 4-8 hours after breakfast | Posted | Mean | Standard Deviation | micrograms/4hr | 4 to 8 hours after breakfast |
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| Secondary | Urinary Norepinephrine | Urinary norepinephrine excreted 8-12 hours after breakfast | Posted | Mean | Standard Deviation | micrograms/4hr | 8 to 12 hours after breakfast |
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| Secondary | Supine Systolic Blood Pressure | Supine systolic blood pressure 6 hours after breakfast | Posted | Mean | Standard Deviation | mm Hg | Supine-6 hours after breakfast on both study days. |
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| Secondary | Supine Heart Rate | Supine heart rate 6 hours after breakfast | Posted | Mean | Standard Deviation | beats per minute | 6 hours after breakfast |
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| Secondary | Urinary Sodium | Urinary sodium excreted 0-4 hours after breakfast. | Posted | Mean | Standard Deviation | mEq/4hr | 0-4 hours after breakfast |
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| Secondary | Urinary Sodium | urinary sodium 8-12 hours after breakfast | Posted | Mean | Standard Deviation | mEq/4hr | 8-12 hours after breakfast |
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| 14 |
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| 14 |
| EG001 | Fixed Sodium Study Diet | Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). | 0 | 14 | 0 | 14 |
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