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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited in the Nashville, TN area between November, 2009 and November, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow for 2 periods

Period 1:   Fixed Sodium Study Diet
    Fixed Sodium Diet +/- Fava Beans
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 2:   Fixed Sodium Diet + Fava Beans
    Fixed Sodium Diet +/- Fava Beans
STARTED   14 
COMPLETED   13 [1] 
NOT COMPLETED   1 
Adverse Event                1 
[1] 1 participant withdrew with blood in his urine on the fava bean study day.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Baseline Measures
   Fava Beans 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   14 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.2  (12.9) 
Gender 
[Units: Participants]
 
Female   10 
Male   4 
Region of Enrollment 
[Units: Participants]
 
United States   14 


  Outcome Measures

1.  Primary:   Plasma Dopa 1 hr After Breakfast   [ Time Frame: Plasma samples collected 1 hour after breakfast on both study days. ]

2.  Primary:   Urinary Dopa   [ Time Frame: 4-8 hours after breakfast ]

3.  Primary:   Urinary Sodium   [ Time Frame: 4 to 8 hours after breakfast ]

4.  Secondary:   Plasma Dopa 2 Hrs After Breakfast   [ Time Frame: Plasma samples collected 2 hours after breakfast on both study days. ]

5.  Secondary:   Plasma Dopa 4 Hrs After Breakfast   [ Time Frame: Plasma samples collected 4 hours after breakfast on both study days. ]

6.  Secondary:   Plasma Dopa 6 Hrs After Breakfast   [ Time Frame: Plasma samples collected 6 hours after breakfast on both study days. ]

7.  Secondary:   Plasma Norepinephrine   [ Time Frame: 1 hour after breakfast on both study days. ]

8.  Secondary:   Plasma Norepinephrine   [ Time Frame: 2 hours after breakfast on both study days. ]

9.  Secondary:   Plasma Norepinephrine   [ Time Frame: 4 hours after breakfast on both study days. ]

10.  Secondary:   Plasma Norepinephrine   [ Time Frame: 6 hours after breakfast on both study days. ]

11.  Secondary:   Plasma Dopamine   [ Time Frame: 1 hour after breakfast ]

12.  Secondary:   Plasma Dopamine   [ Time Frame: 2 hours after breakfast on both study days. ]

13.  Secondary:   Plasma Dopamine   [ Time Frame: 4 hours after breakfast on both study days. ]

14.  Secondary:   Plasma Dopamine   [ Time Frame: Plasma samplesPlasma dopamine 6 hours after breakfast on both study days. ]

15.  Secondary:   Urinary Dopa   [ Time Frame: 0-4 hours after breakfast ]

16.  Secondary:   Urinary Dopa   [ Time Frame: 8-12 hours after breakfast ]

17.  Secondary:   Urinary Dopamine   [ Time Frame: 0 to 4 hours after breakfast ]

18.  Secondary:   Urinary Dopamine   [ Time Frame: 4 to 8 hours after breakfast ]

19.  Secondary:   Urinary Dopamine   [ Time Frame: 8 to 12 hours after breakfast ]

20.  Secondary:   Urinary Norepinephrine   [ Time Frame: 0 to 4 hours after breakfast ]

21.  Secondary:   Urinary Norepinephrine   [ Time Frame: 4 to 8 hours after breakfast ]

22.  Secondary:   Urinary Norepinephrine   [ Time Frame: 8 to 12 hours after breakfast ]

23.  Secondary:   Supine Systolic Blood Pressure   [ Time Frame: Supine-6 hours after breakfast on both study days. ]

24.  Secondary:   Supine Heart Rate   [ Time Frame: 6 hours after breakfast ]

25.  Secondary:   Urinary Sodium   [ Time Frame: 0-4 hours after breakfast ]

26.  Secondary:   Urinary Sodium   [ Time Frame: 8-12 hours after breakfast ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: emily.garland@vanderbilt.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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