Trial Outcomes & Findings for Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration (NCT NCT01064739)

NCT ID: NCT01064739

Last Updated: 2016-05-26

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 14 participants
• Primary outcome timeframe: Plasma samples collected 1 hour after breakfast on both study days.
• Results posted on: 2016-05-26

Participant Flow

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

Participant milestones

Measure	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.
Fixed Sodium Study Diet STARTED	14
Fixed Sodium Study Diet COMPLETED	14
Fixed Sodium Study Diet NOT COMPLETED	0
Fixed Sodium Diet + Fava Beans STARTED	14
Fixed Sodium Diet + Fava Beans COMPLETED	13
Fixed Sodium Diet + Fava Beans NOT COMPLETED	1

Reasons for withdrawal

Measure	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.
Fixed Sodium Diet + Fava Beans Adverse Event	1

Baseline Characteristics

Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration

Baseline characteristics by cohort

Measure	Fava Beans n=14 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35.2 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Plasma 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.

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Plasma Dopa 1 hr After Breakfast	11670 pg/mL Standard Deviation 5440	1705 pg/mL Standard Deviation 530

PRIMARY outcome

Timeframe: 4-8 hours after breakfast

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.

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Urinary Dopa	24.2 micrograms/4hr Standard Deviation 21.2	4.4 micrograms/4hr Standard Deviation 3.0

PRIMARY outcome

Timeframe: 4 to 8 hours after breakfast

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.

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Urinary Sodium	24 mEq/4 hr Standard Deviation 8.8	35 mEq/4 hr Standard Deviation 17

SECONDARY outcome

Timeframe: Plasma 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.

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Plasma Dopa 2 Hrs After Breakfast	1689 pg/mL Standard Deviation 451	8122 pg/mL Standard Deviation 3626

SECONDARY outcome

Timeframe: Plasma 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.

Outcome measures

Measure	Fava Beans n=12 Participants 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	Fixed Sodium Study Diet n=12 Participants A study diet with a fixed amount of sodium and no fava beans.
Plasma Dopa 4 Hrs After Breakfast	1800 pg/mL Standard Deviation 608	3473 pg/mL Standard Deviation 1106

SECONDARY outcome

Timeframe: Plasma 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.

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Plasma Dopa 6 Hrs After Breakfast	1712 pg/mL Standard Deviation 488	7385 pg/mL Standard Deviation 3489

SECONDARY outcome

Timeframe: 1 hour after breakfast on both study days.

Plasma norepinephrine 1 hour after breakfast

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Plasma Norepinephrine	188 pg/mL Standard Deviation 72	228 pg/mL Standard Deviation 132

SECONDARY outcome

Timeframe: 2 hours after breakfast on both study days.

Plasma norepinephrine 2 hours after breakfast

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Plasma Norepinephrine	173 pg/mL Standard Deviation 114	304 pg/mL Standard Deviation 226

SECONDARY outcome

Timeframe: 4 hours after breakfast on both study days.

Plasma norepinephrine 4 hours after breakfast

Outcome measures

Measure	Fava Beans n=12 Participants 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	Fixed Sodium Study Diet n=12 Participants A study diet with a fixed amount of sodium and no fava beans.
Plasma Norepinephrine	155 pg/mL Standard Deviation 74	266 pg/mL Standard Deviation 220

SECONDARY outcome

Timeframe: 6 hours after breakfast on both study days.

Plasma norepinephrine 6 hours after breakfast

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Plasma Norepinephrine	354 pg/mL Standard Deviation 273	159 pg/mL Standard Deviation 89

SECONDARY outcome

Timeframe: 1 hour after breakfast

Plasma dopamine 1 hour after breakfast

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Plasma Dopamine	90 pg/mL Standard Deviation 47	6 pg/mL Standard Deviation 3

SECONDARY outcome

Timeframe: 2 hours after breakfast on both study days.

Plasma dopamine 2 hours after breakfast

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Plasma Dopamine	7.4 pg/mL Standard Deviation 2.9	93.8 pg/mL Standard Deviation 54.1

SECONDARY outcome

Timeframe: 4 hours after breakfast on both study days.

Plasma dopamine 4 hours after breakfast

Outcome measures

Measure	Fava Beans n=12 Participants 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	Fixed Sodium Study Diet n=12 Participants A study diet with a fixed amount of sodium and no fava beans.
Plasma Dopamine	6.7 pg/mL Standard Deviation 2.8	50.3 pg/mL Standard Deviation 26.6

SECONDARY outcome

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

Plasma dopamine 6 hours after breakfast

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Plasma Dopamine	7.9 pg/mL Standard Deviation 3.1	91.3 pg/mL Standard Deviation 41.9

SECONDARY outcome

Timeframe: 0-4 hours after breakfast

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.

Outcome measures

Measure	Fava Beans n=10 Participants 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	Fixed Sodium Study Diet n=10 Participants A study diet with a fixed amount of sodium and no fava beans.
Urinary Dopa	3.80 ug/4hr Standard Deviation 2.13	22.09 ug/4hr Standard Deviation 13.42

SECONDARY outcome

Timeframe: 8-12 hours after breakfast

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.

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Urinary Dopa	3.43 micrograms/4hr Standard Deviation 1.31	5.43 micrograms/4hr Standard Deviation 2.78

SECONDARY outcome

Timeframe: 0 to 4 hours after breakfast

Urinary dopamine excreted 0 to 4 hours after breakfast

Outcome measures

Measure	Fava Beans n=10 Participants 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	Fixed Sodium Study Diet n=10 Participants A study diet with a fixed amount of sodium and no fava beans.
Urinary Dopamine	45.3 micrograms/4hr Standard Deviation 21.4	306.3 micrograms/4hr Standard Deviation 116.2

SECONDARY outcome

Timeframe: 4 to 8 hours after breakfast

Urinary dopamine excreted 4 to 8 hours after breakfast

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Urinary Dopamine	360 micrograms/4 hours Standard Deviation 235	54.0 micrograms/4 hours Standard Deviation 29.5

SECONDARY outcome

Timeframe: 8 to 12 hours after breakfast

Urinary dopamine excreted 8 to 12 hours after breakfast

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Urinary Dopamine	44.2 micrograms/4hr Standard Deviation 17.0	159.2 micrograms/4hr Standard Deviation 111.5

SECONDARY outcome

Timeframe: 0 to 4 hours after breakfast

Urinary norepinephrine excreted 0-4 hours after breakfast

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Urinary Norepinephrine	11.7 micrograms/4 hours Standard Deviation 5.1	5.1 micrograms/4 hours Standard Deviation 2.3

SECONDARY outcome

Timeframe: 4 to 8 hours after breakfast

Urinary norepinephrine excreted 4-8 hours after breakfast

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Urinary Norepinephrine	8.43 micrograms/4hr Standard Deviation 6.25	13.26 micrograms/4hr Standard Deviation 6.99

SECONDARY outcome

Timeframe: 8 to 12 hours after breakfast

Urinary norepinephrine excreted 8-12 hours after breakfast

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Urinary Norepinephrine	6.72 micrograms/4hr Standard Deviation 6.77	11.35 micrograms/4hr Standard Deviation 3.44

SECONDARY outcome

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

Supine systolic blood pressure 6 hours after breakfast

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Supine Systolic Blood Pressure	104 mm Hg Standard Deviation 7	102 mm Hg Standard Deviation 8

SECONDARY outcome

Timeframe: 6 hours after breakfast

Supine heart rate 6 hours after breakfast

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Supine Heart Rate	66 beats per minute Standard Deviation 13	65 beats per minute Standard Deviation 15

SECONDARY outcome

Timeframe: 0-4 hours after breakfast

Urinary sodium excreted 0-4 hours after breakfast.

Outcome measures

Measure	Fava Beans n=10 Participants 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	Fixed Sodium Study Diet n=10 Participants A study diet with a fixed amount of sodium and no fava beans.
Urinary Sodium	29.9 mEq/4hr Standard Deviation 11.4	23.5 mEq/4hr Standard Deviation 6.5

SECONDARY outcome

Timeframe: 8-12 hours after breakfast

urinary sodium 8-12 hours after breakfast

Outcome measures

Measure	Fava Beans n=13 Participants 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	Fixed Sodium Study Diet n=13 Participants A study diet with a fixed amount of sodium and no fava beans.
Urinary Sodium	32.5 mEq/4hr Standard Deviation 17.3	14.5 mEq/4hr Standard Deviation 6.9

Adverse Events

Fava Beans

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Fixed Sodium Study Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fava Beans n=14 participants at risk 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	Fixed Sodium Study Diet n=14 participants at risk 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).
Renal and urinary disorders blood in urine	7.1% 1/14 • Number of events 1 • 2 1/2 years	0.00% 0/14 • 2 1/2 years

Additional Information

Dr. Emily Garland

Vanderbilt University

Phone: 615 936 1748

Email: emily.garland@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place