Clinical trial NCT01676103: The Effects of Supplementing Tyrosine on Blood Pressure in Parkinson's Disease
Official title: The Effects of Supplementing Tyrosine on Blood Pressure in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease (PD)
Orthostatic hypotension (OH)
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2012-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this experiment is:

* Primary: To determine the effects of tyrosine supplementation on orthostatic hypotension in people with PD.
* Secondary: To determine the effects of tyrosine supplementation in people with PD with autonomic insufficiency on HR, BP, and norepinephrine responses during acute exercise stress.

Orthostatic hypotension and autonomic abnormalities are a common problem for individuals who suffer from PD, especially as it leads to lightheadedness and falling. For those affected, it can drastically reduce quality of life. It has been hypothesized that tyrosine may impact upon individuals suffering from PD. There is ample evidence in animal models that supports our theory; however there is no clinical evidence of the impact tyrosine supplementation may have in PD patients who suffer from orthostatic hypotension and blunted BP and HR responses. Positive findings that supplemental tyrosine increases BP and HR in people with PD during daily activities such as standing up from a chair and walking can lead to new therapies to improve Parkinsonian orthostatic hypotension.

Hypothesis We will test the hypothesis that symptomatic individuals with PD on dopamine therapy who suffer from orthostatic hypotension and blunted HR and BP responses will improve after tyrosine supplementation.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PD according to the UK Brain Bank Diagnostic criteria
* Diagnosis of orthostatic hypotension according to EFNS guidelines
* Able to walk on a treadmill comfortably for 6-10 minutes
* Currently taking levodopa
* Subjects between the age of 50-80 years old

Exclusion Criteria:

* Currently taking an amino acid supplement
* Currently taking medication that affects BP
* Normal BP response to testing

Primary outcomes:
measure: Determine the effects of tyrosine supplementation on orthostatic hypotension in people with PD
timeFrame: 7 days
Secondary outcomes:
measure: To determine the effects of tyrosine supplementation in people with PD with autonomic insufficiency on heart rate, blood pressure, and norepinephrine responses during acute exercise stress.
timeFrame: 7 days
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: New York Institue of Technology
state: New York
Study officials:
affiliation: New York Institute of Technology
name: Joanne DiFrancisco-Donoghue, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: DiFrancisco-Donoghue J, Rabin E, Lamberg EM, Werner WG. Effects of Tyrosine on Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled Trial. Mov Disord Clin Pract. 2014 Oct 23;1(4):348-353. doi: 10.1002/mdc3.12082. eCollection 2014 Dec.