Early Phase 1
N=14
Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration
Healthy Participants
Bottom Line
View on ClinicalTrials.gov: NCT01064739 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Plasma Dopa 1 hr After Breakfast — 11670; 1705 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Fava beans (Dietary_supplement); Fixed Sodium Diet (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Dopa 1 hr After Breakfast |
11670; 1705 | — |
| PRIMARY Urinary Dopa |
3.43; 5.43 | — |
| PRIMARY Urinary Sodium |
32.5; 14.5 | — |
| SECONDARY Plasma Dopa 2 Hrs After Breakfast |
1689; 8122 | — |
| SECONDARY Plasma Dopa 4 Hrs After Breakfast |
1800; 3473 | — |
| SECONDARY Plasma Dopa 6 Hrs After Breakfast |
1712; 7385 | — |
| SECONDARY Plasma Norepinephrine |
354; 159 | — |
| SECONDARY Plasma Norepinephrine |
354; 159 | — |
| SECONDARY Plasma Norepinephrine |
354; 159 | — |
| SECONDARY Plasma Norepinephrine |
354; 159 | — |
| SECONDARY Plasma Dopamine |
7.9; 91.3 | — |
| SECONDARY Plasma Dopamine |
7.9; 91.3 | — |
| SECONDARY Plasma Dopamine |
7.9; 91.3 | — |
| SECONDARY Plasma Dopamine |
7.9; 91.3 | — |
| SECONDARY Urinary Dopa |
3.43; 5.43 | — |
| SECONDARY Urinary Dopa |
3.43; 5.43 | — |
| SECONDARY Urinary Dopamine |
44.2; 159.2 | — |
| SECONDARY Urinary Dopamine |
44.2; 159.2 | — |
| SECONDARY Urinary Dopamine |
44.2; 159.2 | — |
| SECONDARY Urinary Norepinephrine |
6.72; 11.35 | — |
| SECONDARY Urinary Norepinephrine |
6.72; 11.35 | — |
| SECONDARY Urinary Norepinephrine |
6.72; 11.35 | — |
| SECONDARY Supine Systolic Blood Pressure |
104; 102 | — |
| SECONDARY Supine Heart Rate |
66; 65 | — |
| SECONDARY Urinary Sodium |
32.5; 14.5 | — |
| SECONDARY Urinary Sodium |
32.5; 14.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01064739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.