The Effects of Supplementing Tyrosine on Blood Pressure in Parkinson's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01676103|
Recruitment Status : Completed
First Posted : August 30, 2012
Last Update Posted : April 16, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Dietary Supplement: Tyrosine Other: Placebo Comparator:Sugar Pill||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effects of Supplementing Tyrosine on Blood Pressure in Parkinson's Disease|
|Study Start Date :||September 2012|
|Primary Completion Date :||November 2013|
|Study Completion Date :||November 2013|
Tyrosine supplementation (500 mg 2x daily) for 7 days
Dietary Supplement: Tyrosine
Tyrosine supplementation (500 mg 2 x daily) for 7 days
Placebo Comparator: Sugar pill
Placebo sugar pills (2x daily) for 7 days
Other: Placebo Comparator:Sugar Pill
Placebo sugar pills (2x daily
- Determine the effects of tyrosine supplementation on orthostatic hypotension in people with PD [ Time Frame: 7 days ]
Orthostatic Blood Pressure Testing:
Subjects will sit and rest for 10 minutes. Blood pressure will be taken in this resting position after the 10 minutes. Subjects will then stand upright for 3 minutes. Blood pressure will be taken every minute for those 3 minutes. A drop in systolic BP of 20 mmHg and a 10 mmHg in diastolic drop within these 3 minutes indicates orthostatic hypotension according to the American Academy of Neurology.
Norepinephrine and tyrosine will all be examined via blood samples drawn by a medical assistant or physician from the forearm vein in vacutainer tubes. Two vacutainers of three cc's of blood will be collected and frozen until analyzed.
- 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. [ Time Frame: 7 days ]
An exercise stress test using a Modified Bruce Protocol, which consists of five 3-minute stages on a treadmill, will be used to implement acute stress. During the test, heart rate, oxygen consumption (VO2), Respiratory Exchange Ratio (RER), and 12 lead EKG tracings will be recorded at 1-minute intervals and BP and a rate of perceived exertion (RPE) will be recorded. The treadmill test will conclude when subjects attain peak exercise. Peak exercise will be determined when a subject attains any one of the following: 1) 85% of target heart rate; 2) an RPE of 8; 3) inability to maintain the pace of the treadmill; 4) an RER of over 1.3. Additionally, the American College of Sports Medicine (ACSM) guidelines for terminating exercise testing will be followed.
Subjects will be tested on the first visit and then receive supplementation or placebo for 2x daily for 7 days. Subjects will then repeat all the tests they performed on the first visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676103
|United States, New York|
|New York Institue of Technology|
|Old Westbury, New York, United States, 11568-8000|
|Principal Investigator:||Joanne DiFrancisco-Donoghue, PhD||New York Institute of Technology|