Blood PressureEarly Phase 1NCT02259049
The Effects of L-Tyrosine on 24 Hour Blood Pressure and Heart Rate in Parkinson's Disease
A Early Phase 1 study testing L-tyrosine and Sugar Pill in people with Blood Pressure, run by New York Institute of Technology at 1 site in United States.
Trial summary
The investigators are observing the effects 2,000 mg of L-tyrosine will have on 24 hour blood pressure fluctuations in individuals with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 to 84 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- L-tyrosine and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Sep 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 40 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects must have a diagnosis of PD by a licensed neurologist according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (UKPDBB).(Goetz, 2010) The UKPDBB is a 3 step diagnostic tool which defines inclusion and exclusion criteria for diagnosing PD
- between 35 and 79 years of age
- mentally able to participate in the study
Who cannot join
- Pregnancy
- any person who is currently taking amino acid supplements.
- Any history of myocardial infarction, stent, or CABG
- Phenylketonurics
- Untreated hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Institute of Technology
Old Westbury, New York, 11758
About this study
Official title: The Effects of L-Tyrosine on Non-invasive Ambulatory Blood Pressure and Heart Rate Monitoring in Parkinson's Disease
The investigators are observing the effects 2,000 mg of L-tyrosine will have on 24 hour blood pressure fluctuations in individuals with Parkinson's disease.
Read the detailed description
We will be monitoring 24 hour ambulatory BP and HR in subjects with PD on 3 separate visits. The first visit will be without an intervention to establish a baseline of 24 hour BP fluctuations. One week later the subject will be given either L-tyrosine (2,000 mg) with B6 (10 mg) or a sugar pill. We will monitor 24 hour BP and HR after supplementation. One week later the subject will repeat the same procedures with either supplement or placebo.
This is a total of 3 visits with 24 hour ambulatory BP and HR monitoring.
- Conditions
- Blood Pressure
- Being tested
- L-tyrosine, Sugar Pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-tyrosineDietary supplement
Each subject will receive 2,000 mg of L-tyrosine BID for 24 hours.
Sugar PillDietary supplement
Each subject will receive a sugar pill BID for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| L-Tyrosine | Active comparator | We will administer 1,000 mg of L-tyrosine BID for 24 hours and record BP and HR. Receives: Dietary Supplement: L-tyrosine; Dietary Supplement: Sugar Pill |
| Sugar Pill | Placebo comparator | We will administer a sugar pill BID for 24 hours and record BP and HR. Receives: Dietary Supplement: L-tyrosine; Dietary Supplement: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Measured: 24 hours
Secondary outcomes (1)
Heart Rate
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne DiFrancisco-Donoghue, New York Institute of Technology
- Investigators
- Joanne Donoghue, PhD, Principal investigator, New York Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259049
- Sponsor's protocol ID
- BHS-1056
- Status last verified
- Sep 2014
- First submitted
- 3 Oct 2014
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of L-Tyrosine on Non-invasive Ambulatory Blood Pressure and Heart Rate Monitoring in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02259049
- Acronym / sponsor ID
- BHS-1056
- Conditions
- Blood Pressure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are observing the effects 2,000 mg of L-tyrosine will have on 24 hour blood pressure fluctuations in individuals with Parkinson's disease.
Detailed description
We will be monitoring 24 hour ambulatory BP and HR in subjects with PD on 3 separate visits. The first visit will be without an intervention to establish a baseline of 24 hour BP fluctuations. One week later the subject will be given either L-tyrosine (2,000 mg) with B6 (10 mg) or a sugar pill. We will monitor 24 hour BP and HR after supplementation. One week later the subject will repeat the same procedures with either supplement or placebo.
This is a total of 3 visits with 24 hour ambulatory BP and HR monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-Tyrosine | Active comparator | Dietary Supplement: L-tyrosine, Dietary Supplement: Sugar PillWe will administer 1,000 mg of L-tyrosine BID for 24 hours and record BP and HR. |
| Sugar Pill | Placebo comparator | Dietary Supplement: L-tyrosine, Dietary Supplement: Sugar PillWe will administer a sugar pill BID for 24 hours and record BP and HR. |
Who may qualify
- Ages
- 40 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All subjects must have a diagnosis of PD by a licensed neurologist according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (UKPDBB).(Goetz, 2010) The UKPDBB is a 3 step diagnostic tool which defines inclusion and exclusion criteria for diagnosing PD
- between 35 and 79 years of age
- mentally able to participate in the study
Key exclusion criteria (5 listed)
- Pregnancy
- any person who is currently taking amino acid supplements.
- Any history of myocardial infarction, stent, or CABG
- Phenylketonurics
- Untreated hypertension
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 |
|---|---|---|
| L-tyrosineEach subject will receive 2,000 mg of L-tyrosine BID for 24 hours. | Dietary supplement | L-Tyrosine, Sugar Pill |
| Sugar PillEach subject will receive a sugar pill BID for 24 hours. | Dietary supplement | L-Tyrosine, Sugar Pill |
Primary outcome
Blood Pressure
Time frame: 24 hours
1 secondary outcome
Heart Rate
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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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.
Joanne Donoghue, PhD principal investigator
New York Institute of Technology
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 L-tyrosine and Sugar Pill in people with Blood Pressure, run by New York Institute of Technology 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 3 inclusion and 5 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 20 Jan 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood Pressure (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2016.