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Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration

Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01064739
Enrollment
14
Registered
2010-02-08
Start date
2007-01-31
Completion date
2012-12-31
Last updated
2016-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

Healthy Volunteers, Fava bean consumption, L-Dopa content in Fava Beans, Sodium, Potassium, Electrolyte Balance, Natriuresis

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTFava 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

OTHERFixed Sodium Diet

Fixed sodium low monoamine diet

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Plasma Dopa 1 hr After BreakfastPlasma samples collected 1 hour after breakfast on both study days.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.
Urinary Dopa4-8 hours after breakfastUrinary 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.
Urinary Sodium4 to 8 hours after breakfastUrinary 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.

Secondary

MeasureTime frameDescription
Plasma Norepinephrine1 hour after breakfast on both study days.Plasma norepinephrine 1 hour after breakfast
Plasma Dopamine1 hour after breakfastPlasma dopamine 1 hour after breakfast
Urinary Dopa0-4 hours after breakfastUrinary 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.
Urinary Dopamine0 to 4 hours after breakfastUrinary dopamine excreted 0 to 4 hours after breakfast
Plasma Dopa 2 Hrs After BreakfastPlasma samples collected 2 hours after breakfast on both study days.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.
Supine Systolic Blood PressureSupine-6 hours after breakfast on both study days.Supine systolic blood pressure 6 hours after breakfast
Supine Heart Rate6 hours after breakfastSupine heart rate 6 hours after breakfast
Urinary Sodium0-4 hours after breakfastUrinary sodium excreted 0-4 hours after breakfast.
Urinary Norepinephrine0 to 4 hours after breakfastUrinary norepinephrine excreted 0-4 hours after breakfast
Plasma Dopa 4 Hrs After BreakfastPlasma samples collected 4 hours after breakfast on both study days.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 Dopa 6 Hrs After BreakfastPlasma samples collected 6 hours after breakfast on both study days.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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited in the Nashville, TN area between November, 2009 and November, 2010.

Participants by arm

ArmCount
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
14
Total14

Withdrawals & dropouts

PeriodReasonFG000
Fixed Sodium Diet + Fava BeansAdverse Event1

Baseline characteristics

CharacteristicFava Beans
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
Age, Continuous35.2 years
STANDARD_DEVIATION 12.9
Region of Enrollment
United States
14 participants
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
1 / 140 / 14
serious
Total, serious adverse events
0 / 140 / 14

Outcome results

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.

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

ArmMeasureValue (MEAN)Dispersion
Fava BeansPlasma Dopa 1 hr After Breakfast11670 pg/mLStandard Deviation 5440
Fixed Sodium Study DietPlasma Dopa 1 hr After Breakfast1705 pg/mLStandard Deviation 530
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.

Time frame: 4-8 hours after breakfast

ArmMeasureValue (MEAN)Dispersion
Fava BeansUrinary Dopa24.2 micrograms/4hrStandard Deviation 21.2
Fixed Sodium Study DietUrinary Dopa4.4 micrograms/4hrStandard Deviation 3
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.

Time frame: 4 to 8 hours after breakfast

ArmMeasureValue (MEAN)Dispersion
Fava BeansUrinary Sodium24 mEq/4 hrStandard Deviation 8.8
Fixed Sodium Study DietUrinary Sodium35 mEq/4 hrStandard Deviation 17
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.

Time frame: Plasma samples collected 2 hours after breakfast on both study days.

ArmMeasureValue (MEAN)Dispersion
Fava BeansPlasma Dopa 2 Hrs After Breakfast1689 pg/mLStandard Deviation 451
Fixed Sodium Study DietPlasma Dopa 2 Hrs After Breakfast8122 pg/mLStandard Deviation 3626
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.

Time frame: Plasma samples collected 4 hours after breakfast on both study days.

ArmMeasureValue (MEAN)Dispersion
Fava BeansPlasma Dopa 4 Hrs After Breakfast1800 pg/mLStandard Deviation 608
Fixed Sodium Study DietPlasma Dopa 4 Hrs After Breakfast3473 pg/mLStandard Deviation 1106
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.

Time frame: Plasma samples collected 6 hours after breakfast on both study days.

ArmMeasureValue (MEAN)Dispersion
Fava BeansPlasma Dopa 6 Hrs After Breakfast1712 pg/mLStandard Deviation 488
Fixed Sodium Study DietPlasma Dopa 6 Hrs After Breakfast7385 pg/mLStandard Deviation 3489
Secondary

Plasma Dopamine

Plasma dopamine 6 hours after breakfast

Time frame: Plasma samplesPlasma dopamine 6 hours after breakfast on both study days.

ArmMeasureValue (MEAN)Dispersion
Fava BeansPlasma Dopamine7.9 pg/mLStandard Deviation 3.1
Fixed Sodium Study DietPlasma Dopamine91.3 pg/mLStandard Deviation 41.9
Secondary

Plasma Dopamine

Plasma dopamine 1 hour after breakfast

Time frame: 1 hour after breakfast

ArmMeasureValue (MEAN)Dispersion
Fava BeansPlasma Dopamine90 pg/mLStandard Deviation 47
Fixed Sodium Study DietPlasma Dopamine6 pg/mLStandard Deviation 3
Secondary

Plasma Dopamine

Plasma dopamine 2 hours after breakfast

Time frame: 2 hours after breakfast on both study days.

ArmMeasureValue (MEAN)Dispersion
Fava BeansPlasma Dopamine7.4 pg/mLStandard Deviation 2.9
Fixed Sodium Study DietPlasma Dopamine93.8 pg/mLStandard Deviation 54.1
Secondary

Plasma Dopamine

Plasma dopamine 4 hours after breakfast

Time frame: 4 hours after breakfast on both study days.

ArmMeasureValue (MEAN)Dispersion
Fava BeansPlasma Dopamine6.7 pg/mLStandard Deviation 2.8
Fixed Sodium Study DietPlasma Dopamine50.3 pg/mLStandard Deviation 26.6
Secondary

Plasma Norepinephrine

Plasma norepinephrine 2 hours after breakfast

Time frame: 2 hours after breakfast on both study days.

ArmMeasureValue (MEAN)Dispersion
Fava BeansPlasma Norepinephrine173 pg/mLStandard Deviation 114
Fixed Sodium Study DietPlasma Norepinephrine304 pg/mLStandard Deviation 226
Secondary

Plasma Norepinephrine

Plasma norepinephrine 6 hours after breakfast

Time frame: 6 hours after breakfast on both study days.

ArmMeasureValue (MEAN)Dispersion
Fava BeansPlasma Norepinephrine354 pg/mLStandard Deviation 273
Fixed Sodium Study DietPlasma Norepinephrine159 pg/mLStandard Deviation 89
Secondary

Plasma Norepinephrine

Plasma norepinephrine 4 hours after breakfast

Time frame: 4 hours after breakfast on both study days.

ArmMeasureValue (MEAN)Dispersion
Fava BeansPlasma Norepinephrine155 pg/mLStandard Deviation 74
Fixed Sodium Study DietPlasma Norepinephrine266 pg/mLStandard Deviation 220
Secondary

Plasma Norepinephrine

Plasma norepinephrine 1 hour after breakfast

Time frame: 1 hour after breakfast on both study days.

ArmMeasureValue (MEAN)Dispersion
Fava BeansPlasma Norepinephrine188 pg/mLStandard Deviation 72
Fixed Sodium Study DietPlasma Norepinephrine228 pg/mLStandard Deviation 132
Secondary

Supine Heart Rate

Supine heart rate 6 hours after breakfast

Time frame: 6 hours after breakfast

ArmMeasureValue (MEAN)Dispersion
Fava BeansSupine Heart Rate66 beats per minuteStandard Deviation 13
Fixed Sodium Study DietSupine Heart Rate65 beats per minuteStandard Deviation 15
Secondary

Supine Systolic Blood Pressure

Supine systolic blood pressure 6 hours after breakfast

Time frame: Supine-6 hours after breakfast on both study days.

ArmMeasureValue (MEAN)Dispersion
Fava BeansSupine Systolic Blood Pressure104 mm HgStandard Deviation 7
Fixed Sodium Study DietSupine Systolic Blood Pressure102 mm HgStandard Deviation 8
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.

Time frame: 0-4 hours after breakfast

ArmMeasureValue (MEAN)Dispersion
Fava BeansUrinary Dopa3.80 ug/4hrStandard Deviation 2.13
Fixed Sodium Study DietUrinary Dopa22.09 ug/4hrStandard Deviation 13.42
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.

Time frame: 8-12 hours after breakfast

ArmMeasureValue (MEAN)Dispersion
Fava BeansUrinary Dopa3.43 micrograms/4hrStandard Deviation 1.31
Fixed Sodium Study DietUrinary Dopa5.43 micrograms/4hrStandard Deviation 2.78
Secondary

Urinary Dopamine

Urinary dopamine excreted 4 to 8 hours after breakfast

Time frame: 4 to 8 hours after breakfast

ArmMeasureValue (MEAN)Dispersion
Fava BeansUrinary Dopamine360 micrograms/4 hoursStandard Deviation 235
Fixed Sodium Study DietUrinary Dopamine54.0 micrograms/4 hoursStandard Deviation 29.5
Secondary

Urinary Dopamine

Urinary dopamine excreted 8 to 12 hours after breakfast

Time frame: 8 to 12 hours after breakfast

ArmMeasureValue (MEAN)Dispersion
Fava BeansUrinary Dopamine44.2 micrograms/4hrStandard Deviation 17
Fixed Sodium Study DietUrinary Dopamine159.2 micrograms/4hrStandard Deviation 111.5
Secondary

Urinary Dopamine

Urinary dopamine excreted 0 to 4 hours after breakfast

Time frame: 0 to 4 hours after breakfast

ArmMeasureValue (MEAN)Dispersion
Fava BeansUrinary Dopamine45.3 micrograms/4hrStandard Deviation 21.4
Fixed Sodium Study DietUrinary Dopamine306.3 micrograms/4hrStandard Deviation 116.2
Secondary

Urinary Norepinephrine

Urinary norepinephrine excreted 4-8 hours after breakfast

Time frame: 4 to 8 hours after breakfast

ArmMeasureValue (MEAN)Dispersion
Fava BeansUrinary Norepinephrine8.43 micrograms/4hrStandard Deviation 6.25
Fixed Sodium Study DietUrinary Norepinephrine13.26 micrograms/4hrStandard Deviation 6.99
Secondary

Urinary Norepinephrine

Urinary norepinephrine excreted 0-4 hours after breakfast

Time frame: 0 to 4 hours after breakfast

ArmMeasureValue (MEAN)Dispersion
Fava BeansUrinary Norepinephrine11.7 micrograms/4 hoursStandard Deviation 5.1
Fixed Sodium Study DietUrinary Norepinephrine5.1 micrograms/4 hoursStandard Deviation 2.3
Secondary

Urinary Norepinephrine

Urinary norepinephrine excreted 8-12 hours after breakfast

Time frame: 8 to 12 hours after breakfast

ArmMeasureValue (MEAN)Dispersion
Fava BeansUrinary Norepinephrine6.72 micrograms/4hrStandard Deviation 6.77
Fixed Sodium Study DietUrinary Norepinephrine11.35 micrograms/4hrStandard Deviation 3.44
Secondary

Urinary Sodium

urinary sodium 8-12 hours after breakfast

Time frame: 8-12 hours after breakfast

ArmMeasureValue (MEAN)Dispersion
Fava BeansUrinary Sodium32.5 mEq/4hrStandard Deviation 17.3
Fixed Sodium Study DietUrinary Sodium14.5 mEq/4hrStandard Deviation 6.9
Secondary

Urinary Sodium

Urinary sodium excreted 0-4 hours after breakfast.

Time frame: 0-4 hours after breakfast

ArmMeasureValue (MEAN)Dispersion
Fava BeansUrinary Sodium29.9 mEq/4hrStandard Deviation 11.4
Fixed Sodium Study DietUrinary Sodium23.5 mEq/4hrStandard Deviation 6.5

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026