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Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration

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ClinicalTrials.gov Identifier: NCT01064739
Recruitment Status : Completed
First Posted : February 8, 2010
Results First Posted : July 31, 2013
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Emily M. Garland, Vanderbilt University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Healthy Participants
Interventions Dietary Supplement: Fava beans
Other: Fixed Sodium Diet
Enrollment 14
Recruitment Details Participants were recruited in the Nashville, TN area between November, 2009 and November, 2010.
Pre-assignment Details  
Arm/Group Title Fixed Sodium Diet +/- Fava Beans
Hide Arm/Group Description 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.
Period Title: Fixed Sodium Study Diet
Started 14 [1]
Completed 14
Not Completed 0
[1]
14 participants consumed the fixed-sodium study diet prior to the fava bean supplement study day.
Period Title: Fixed Sodium Diet + Fava Beans
Started 14
Completed 13 [1]
Not Completed 1
Reason Not Completed
Adverse Event             1
[1]
1 participant withdrew with blood in his urine on the fava bean study day.
Arm/Group Title Fava Beans
Hide Arm/Group Description

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

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
35.2  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
10
  71.4%
Male
4
  28.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Plasma Dopa 1 hr After Breakfast
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fava Beans Fixed Sodium Study Diet
Hide Arm/Group Description:

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

A study diet with a fixed amount of sodium and no fava beans.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: pg/mL
11670  (5440) 1705  (530)
2.Primary Outcome
Title Urinary Dopa
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fava Beans Fixed Sodium Study Diet
Hide Arm/Group Description:

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

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. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: micrograms/4hr
24.2  (21.2) 4.4  (3.0)
3.Primary Outcome
Title Urinary Sodium
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fava Beans Fixed Sodium Study Diet
Hide Arm/Group Description:

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

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).
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: mEq/4 hr
24  (8.8) 35  (17)
4.Secondary Outcome
Title Plasma Dopa 2 Hrs After Breakfast
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: pg/mL
1689  (451) 8122  (3626)
5.Secondary Outcome
Title Plasma Dopa 4 Hrs After Breakfast
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: pg/mL
1800  (608) 3473  (1106)
6.Secondary Outcome
Title Plasma Dopa 6 Hrs After Breakfast
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: pg/mL
1712  (488) 7385  (3489)
7.Secondary Outcome
Title Plasma Norepinephrine
Hide Description Plasma norepinephrine 1 hour after breakfast
Time Frame 1 hour after breakfast on both study days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: pg/mL
188  (72) 228  (132)
8.Secondary Outcome
Title Plasma Norepinephrine
Hide Description Plasma norepinephrine 2 hours after breakfast
Time Frame 2 hours after breakfast on both study days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: pg/mL
173  (114) 304  (226)
9.Secondary Outcome
Title Plasma Norepinephrine
Hide Description Plasma norepinephrine 4 hours after breakfast
Time Frame 4 hours after breakfast on both study days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: pg/mL
155  (74) 266  (220)
10.Secondary Outcome
Title Plasma Norepinephrine
Hide Description Plasma norepinephrine 6 hours after breakfast
Time Frame 6 hours after breakfast on both study days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fava Beans Fixed Sodium Study Diet
Hide Arm/Group Description:

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

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).
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: pg/mL
354  (273) 159  (89)
11.Secondary Outcome
Title Plasma Dopamine
Hide Description Plasma dopamine 1 hour after breakfast
Time Frame 1 hour after breakfast
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fava Beans Fixed Sodium Study Diet
Hide Arm/Group Description:

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

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).
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: pg/mL
90  (47) 6  (3)
12.Secondary Outcome
Title Plasma Dopamine
Hide Description Plasma dopamine 2 hours after breakfast
Time Frame 2 hours after breakfast on both study days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: pg/mL
7.4  (2.9) 93.8  (54.1)
13.Secondary Outcome
Title Plasma Dopamine
Hide Description Plasma dopamine 4 hours after breakfast
Time Frame 4 hours after breakfast on both study days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: pg/mL
6.7  (2.8) 50.3  (26.6)
14.Secondary Outcome
Title Plasma Dopamine
Hide Description Plasma dopamine 6 hours after breakfast
Time Frame Plasma samplesPlasma dopamine 6 hours after breakfast on both study days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: pg/mL
7.9  (3.1) 91.3  (41.9)
15.Secondary Outcome
Title Urinary Dopa
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ug/4hr
3.80  (2.13) 22.09  (13.42)
16.Secondary Outcome
Title Urinary Dopa
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: micrograms/4hr
3.43  (1.31) 5.43  (2.78)
17.Secondary Outcome
Title Urinary Dopamine
Hide Description Urinary dopamine excreted 0 to 4 hours after breakfast
Time Frame 0 to 4 hours after breakfast
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: micrograms/4hr
45.3  (21.4) 306.3  (116.2)
18.Secondary Outcome
Title Urinary Dopamine
Hide Description Urinary dopamine excreted 4 to 8 hours after breakfast
Time Frame 4 to 8 hours after breakfast
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fava Beans Fixed Sodium Study Diet
Hide Arm/Group Description:

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

A study diet with a fixed amount of sodium and no fava beans.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: micrograms/4 hours
360  (235) 54.0  (29.5)
19.Secondary Outcome
Title Urinary Dopamine
Hide Description Urinary dopamine excreted 8 to 12 hours after breakfast
Time Frame 8 to 12 hours after breakfast
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: micrograms/4hr
44.2  (17.0) 159.2  (111.5)
20.Secondary Outcome
Title Urinary Norepinephrine
Hide Description Urinary norepinephrine excreted 0-4 hours after breakfast
Time Frame 0 to 4 hours after breakfast
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fava Beans Fixed Sodium Study Diet
Hide Arm/Group Description:

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

A study diet with a fixed amount of sodium and no fava beans.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: micrograms/4 hours
11.7  (5.1) 5.1  (2.3)
21.Secondary Outcome
Title Urinary Norepinephrine
Hide Description Urinary norepinephrine excreted 4-8 hours after breakfast
Time Frame 4 to 8 hours after breakfast
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: micrograms/4hr
8.43  (6.25) 13.26  (6.99)
22.Secondary Outcome
Title Urinary Norepinephrine
Hide Description Urinary norepinephrine excreted 8-12 hours after breakfast
Time Frame 8 to 12 hours after breakfast
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: micrograms/4hr
6.72  (6.77) 11.35  (3.44)
23.Secondary Outcome
Title Supine Systolic Blood Pressure
Hide Description Supine systolic blood pressure 6 hours after breakfast
Time Frame Supine-6 hours after breakfast on both study days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fava Beans Fixed Sodium Study Diet
Hide Arm/Group Description:

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

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).
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: mm Hg
104  (7) 102  (8)
24.Secondary Outcome
Title Supine Heart Rate
Hide Description Supine heart rate 6 hours after breakfast
Time Frame 6 hours after breakfast
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fava Beans Fixed Sodium Study Diet
Hide Arm/Group Description:

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

A study diet with a fixed amount of sodium and no fava beans.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: beats per minute
66  (13) 65  (15)
25.Secondary Outcome
Title Urinary Sodium
Hide Description Urinary sodium excreted 0-4 hours after breakfast.
Time Frame 0-4 hours after breakfast
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mEq/4hr
29.9  (11.4) 23.5  (6.5)
26.Secondary Outcome
Title Urinary Sodium
Hide Description urinary sodium 8-12 hours after breakfast
Time Frame 8-12 hours after breakfast
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Sodium Study Diet Fava Beans
Hide Arm/Group Description:
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).

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

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: mEq/4hr
32.5  (17.3) 14.5  (6.9)
Time Frame 2 1/2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fava Beans Fixed Sodium Study Diet
Hide Arm/Group Description

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

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).
All-Cause Mortality
Fava Beans Fixed Sodium Study Diet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fava Beans Fixed Sodium Study Diet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fava Beans Fixed Sodium Study Diet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      0/14 (0.00%)    
Renal and urinary disorders     
blood in urine *  1/14 (7.14%)  1 0/14 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Emily Garland
Organization: Vanderbilt University
Phone: 615 936 1748
Responsible Party: Emily M. Garland, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01064739     History of Changes
Other Study ID Numbers: PN 1767
First Submitted: February 5, 2010
First Posted: February 8, 2010
Results First Submitted: March 1, 2013
Results First Posted: July 31, 2013
Last Update Posted: May 26, 2016