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Completed

NCT Number: NCT01676103

The Effects of Supplementing Tyrosine on Blood Pressure in Parkinson's Disease

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.

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Key information

Conditions

Parkinson's Disease Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Hypotension Hypotension, Orthostatic Movement Disorders Nervous System Diseases Neurodegenerative Diseases Orthostatic Intolerance Parkinson Disease Parkinsonian Disorders Primary Dysautonomias Synucleinopathies Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

New York Institue of Technology

Old Westbury, New York, 11568-8000, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tyrosine

Dietary Supplement

Tyrosine supplementation (500 mg 2 x daily) for 7 days

Placebo Comparator:Sugar Pill

Other

Placebo sugar pills (2x daily

Primary outcomes

  1. 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.

    Blood Samples:

    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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

New York Institute of Technology

Other

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 30, 2012
Registry last updated
Apr 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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