Healthy ParticipantsEarly Phase 1NCT01064739
Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration
A Early Phase 1 study testing Fava beans and Fixed Sodium Diet in people with Healthy Participants, run by Vanderbilt University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Fava beans and Fixed Sodium Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2012
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Clinical Research Center
Nashville, Tennessee, 37232-2195
About this study
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:
Read more
- To determine the effect of dietary dopa sources on plasma and urinary catecholamines.
- To investigate the capacity of botanical dopaminergic agents (fava beans) to induce natriuresis in a short term study.
- 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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- Fava beans, Fixed Sodium Diet
- Keywords
- Healthy Volunteers, Fava bean consumption, L-Dopa content in Fava Beans, Sodium, Potassium, Electrolyte Balance, Natriuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fava beansDietary supplement
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 DietOther
Fixed sodium low monoamine diet
| Study group | Role | What they receive |
|---|---|---|
| Study Diet +/- fava beans | Experimental | 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). Receives: Dietary Supplement: Fava beans; Other: Fixed Sodium Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Plasma samples collected 1 hour after breakfast on both study days.
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.
Measured: 4-8 hours after breakfast
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.
Measured: 4 to 8 hours after breakfast
Secondary outcomes (23)
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.
Measured: Plasma samples collected 2 hours after breakfast on both study days.
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.
Measured: Plasma samples collected 4 hours after breakfast on both study days.
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.
Measured: Plasma samples collected 6 hours after breakfast on both study days.
Plasma Norepinephrine
Plasma norepinephrine 1 hour after breakfast
Measured: 1 hour after breakfast on both study days.
Plasma Norepinephrine
Plasma norepinephrine 2 hours after breakfast
Measured: 2 hours after breakfast on both study days.
Plasma Norepinephrine
Plasma norepinephrine 4 hours after breakfast
Measured: 4 hours after breakfast on both study days.
Plasma Norepinephrine
Plasma norepinephrine 6 hours after breakfast
Measured: 6 hours after breakfast on both study days.
Plasma Dopamine
Plasma dopamine 1 hour after breakfast
Measured: 1 hour after breakfast
Plasma Dopamine
Plasma dopamine 2 hours after breakfast
Measured: 2 hours after breakfast on both study days.
Plasma Dopamine
Plasma dopamine 4 hours after breakfast
Measured: 4 hours after breakfast on both study days.
Plasma Dopamine
Plasma dopamine 6 hours after breakfast
Measured: Plasma samplesPlasma dopamine 6 hours after breakfast on both study days.
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.
Measured: 0-4 hours after breakfast
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.
Measured: 8-12 hours after breakfast
Urinary Dopamine
Urinary dopamine excreted 0 to 4 hours after breakfast
Measured: 0 to 4 hours after breakfast
Urinary Dopamine
Urinary dopamine excreted 4 to 8 hours after breakfast
Measured: 4 to 8 hours after breakfast
Urinary Dopamine
Urinary dopamine excreted 8 to 12 hours after breakfast
Measured: 8 to 12 hours after breakfast
Urinary Norepinephrine
Urinary norepinephrine excreted 0-4 hours after breakfast
Measured: 0 to 4 hours after breakfast
Urinary Norepinephrine
Urinary norepinephrine excreted 4-8 hours after breakfast
Measured: 4 to 8 hours after breakfast
Urinary Norepinephrine
Urinary norepinephrine excreted 8-12 hours after breakfast
Measured: 8 to 12 hours after breakfast
Supine Systolic Blood Pressure
Supine systolic blood pressure 6 hours after breakfast
Measured: Supine-6 hours after breakfast on both study days.
Supine Heart Rate
Supine heart rate 6 hours after breakfast
Measured: 6 hours after breakfast
Urinary Sodium
Urinary sodium excreted 0-4 hours after breakfast.
Measured: 0-4 hours after breakfast
Urinary Sodium
urinary sodium 8-12 hours after breakfast
Measured: 8-12 hours after breakfast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startJan 2007
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily M. Garland, Vanderbilt University
- Investigators
- Emily M Garland, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064739
- Sponsor's protocol ID
- PN 1767
- Status last verified
- Aug 2013
- First submitted
- 5 Feb 2010
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Garland EM, Cesar TS, Lonce S, Ferguson MC, Robertson D. An increase in renal dopamine does not stimulate natriuresis after fava bean ingestion. Am J Clin Nutr. 2013 May;97(5):1144-50. doi: 10.3945/ajcn.112.048470. Epub 2013 Apr 3.
PubMed 23553159
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Salt Handling in Postural Tachycardia Syndrome Following Dietary Dopa Administration
- ClinicalTrials.gov ID
- NCT01064739
- Acronym / sponsor ID
- PN 1767
- Conditions
- Healthy Participants
- Keywords
- Healthy Volunteers, Fava bean consumption, L-Dopa content in Fava Beans, Sodium, Potassium, Electrolyte Balance, Natriuresis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Feb 2010 (estimated)
- Results
- Posted 31 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the effect of dietary dopa sources on plasma and urinary catecholamines.
- To investigate the capacity of botanical dopaminergic agents (fava beans) to induce natriuresis in a short term study.
- 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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Diet +/- fava beans | Experimental | Dietary Supplement: Fava beans, Other: Fixed Sodium DietParticipants 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fava beansParticipants 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 | Dietary supplement | Study Diet +/- fava beans |
| Fixed Sodium DietFixed sodium low monoamine diet | Other | Study Diet +/- fava beans |
Primary outcome
Plasma Dopa 1 hr After Breakfast
Time frame: 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.
Urinary Dopa
Time frame: 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.
Urinary Sodium
Time frame: 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.
23 secondary outcomes
Plasma Dopa 2 Hrs After Breakfast
Time frame: Plasma samples collected 2 hours after breakfast on both study days.
Plasma Dopa 4 Hrs After Breakfast
Time frame: Plasma samples collected 4 hours after breakfast on both study days.
Plasma Dopa 6 Hrs After Breakfast
Time frame: Plasma samples collected 6 hours after breakfast on both study days.
Plasma Norepinephrine
Time frame: 1 hour after breakfast on both study days.
Plasma Norepinephrine
Time frame: 2 hours after breakfast on both study days.
Plasma Norepinephrine
Time frame: 4 hours after breakfast on both study days.
Plasma Norepinephrine
Time frame: 6 hours after breakfast on both study days.
Plasma Dopamine
Time frame: 1 hour after breakfast
Plasma Dopamine
Time frame: 2 hours after breakfast on both study days.
Plasma Dopamine
Time frame: 4 hours after breakfast on both study days.
Plasma Dopamine
Time frame: Plasma samplesPlasma dopamine 6 hours after breakfast on both study days.
Urinary Dopa
Time frame: 0-4 hours after breakfast
Urinary Dopa
Time frame: 8-12 hours after breakfast
Urinary Dopamine
Time frame: 0 to 4 hours after breakfast
Urinary Dopamine
Time frame: 4 to 8 hours after breakfast
Urinary Dopamine
Time frame: 8 to 12 hours after breakfast
Urinary Norepinephrine
Time frame: 0 to 4 hours after breakfast
Urinary Norepinephrine
Time frame: 4 to 8 hours after breakfast
Urinary Norepinephrine
Time frame: 8 to 12 hours after breakfast
Supine Systolic Blood Pressure
Time frame: Supine-6 hours after breakfast on both study days.
Supine Heart Rate
Time frame: 6 hours after breakfast
Urinary Sodium
Time frame: 0-4 hours after breakfast
Urinary Sodium
Time frame: 8-12 hours after breakfast
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23553159Garland EM, Cesar TS, Lonce S, Ferguson MC, Robertson D. An increase in renal dopamine does not stimulate natriuresis after fava bean ingestion. Am J Clin Nutr. 2013 May;97(5):1144-50. doi: 10.3945/ajcn.112.048470. Epub 2013 Apr 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily M Garland, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fava beans and Fixed Sodium Diet in people with Healthy Participants, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Dopa 1 hr After Breakfast (time frame: Plasma samples collected 1 hour after breakfast on both study days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01064739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.