The Effects of Supplementing Tyrosine on Blood Pressure in Parkinson's Disease
NCT ID: NCT01676103
Last Updated: 2014-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2012-09-30
2013-11-30
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tyrosine
Tyrosine supplementation (500 mg 2x daily) for 7 days
Tyrosine
Tyrosine supplementation (500 mg 2 x daily) for 7 days
Sugar pill
Placebo sugar pills (2x daily) for 7 days
Placebo Comparator:Sugar Pill
Placebo sugar pills (2x daily
Interventions
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Tyrosine
Tyrosine supplementation (500 mg 2 x daily) for 7 days
Placebo Comparator:Sugar Pill
Placebo sugar pills (2x daily
Eligibility Criteria
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Inclusion 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 medication that affects BP
* Normal BP response to testing
50 Years
80 Years
ALL
No
Sponsors
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Michael J. Fox Foundation for Parkinson's Research
OTHER
New York Institute of Technology
OTHER
Responsible Party
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Principal Investigators
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Joanne DiFrancisco-Donoghue, PhD
Role: PRINCIPAL_INVESTIGATOR
New York Institute of Technology
Locations
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New York Institue of Technology
Old Westbury, New York, United States
Countries
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References
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Barbic F, Perego F, Canesi M, Gianni M, Biagiotti S, Costantino G, Pezzoli G, Porta A, Malliani A, Furlan R. Early abnormalities of vascular and cardiac autonomic control in Parkinson's disease without orthostatic hypotension. Hypertension. 2007 Jan;49(1):120-6. doi: 10.1161/01.HYP.0000250939.71343.7c. Epub 2006 Nov 13.
Kujawa K, Leurgans S, Raman R, Blasucci L, Goetz CG. Acute orthostatic hypotension when starting dopamine agonists in Parkinson's disease. Arch Neurol. 2000 Oct;57(10):1461-3. doi: 10.1001/archneur.57.10.1461.
Goldstein DS, Holmes CS, Dendi R, Bruce SR, Li ST. Orthostatic hypotension from sympathetic denervation in Parkinson's disease. Neurology. 2002 Apr 23;58(8):1247-55. doi: 10.1212/wnl.58.8.1247.
Sharabi Y, Goldstein DS. Mechanisms of orthostatic hypotension and supine hypertension in Parkinson disease. J Neurol Sci. 2011 Nov 15;310(1-2):123-8. doi: 10.1016/j.jns.2011.06.047. Epub 2011 Jul 16.
Karobath M, Diaz JL, Huttunen MO. The effect of L-dopa on the concentrations of tryptophan, tyrosine and serotonin in rat brain. Eur J Pharmacol. 1971 May;14(4):393-6. doi: 10.1016/0014-2999(71)90195-6. No abstract available.
Growdon JH, Melamed E, Logue M, Hefti F, Wurtman RJ. Effects of oral L-tyrosine administration on CSF tyrosine and homovanillic acid levels in patients with Parkinson's disease. Life Sci. 1982 Mar 8;30(10):827-32. doi: 10.1016/0024-3205(82)90596-3.
Glaeser BS, Melamed E, Growdon JH, Wurtman RJ. Elevation of plasma tyrosine after a single oral dose of L-tyrosine. Life Sci. 1979 Jul 16;25(3):265-71. doi: 10.1016/0024-3205(79)90294-7. No abstract available.
Stryjer R, Klein C, Treves TA, Rabey JM. The effects of acute loading with levodopa and levodopa with selegiline on blood pressure and plasma norepinephrine levels in chronic Parkinson's disease patients. Acta Neurol Scand. 2005 Feb;111(2):89-94. doi: 10.1111/j.1600-0404.2005.00294.x.
Tipre DN, Goldstein DS. Cardiac and extracardiac sympathetic denervation in Parkinson's disease with orthostatic hypotension and in pure autonomic failure. J Nucl Med. 2005 Nov;46(11):1775-81.
Riederer P. L-dopa competes with tyrosine and tryptophan for human brain uptake. Nutr Metab. 1980;24(6):417-23. doi: 10.1159/000176359.
Deijen JB, Orlebeke JF. Effect of tyrosine on cognitive function and blood pressure under stress. Brain Res Bull. 1994;33(3):319-23. doi: 10.1016/0361-9230(94)90200-3.
Conlay LA, Maher TJ, Wurtman RJ. Tyrosine increases blood pressure in hypotensive rats. Science. 1981 May 1;212(4494):559-60. doi: 10.1126/science.7209553.
Conlay LA, Maher TJ, Wurtman RJ. Tyrosine accelerates catecholamine synthesis in hemorrhaged hypotensive rats. Brain Res. 1985 Apr 29;333(1):81-4. doi: 10.1016/0006-8993(85)90126-x.
Lahrmann H, Cortelli P, Hilz M, Mathias CJ, Struhal W, Tassinari M. EFNS guidelines on the diagnosis and management of orthostatic hypotension. Eur J Neurol. 2006 Sep;13(9):930-6. doi: 10.1111/j.1468-1331.2006.01512.x.
DiFrancisco-Donoghue J, Elokda A, Lamberg EM, Bono N, Werner WG. Norepinephrine and cardiovascular responses to maximal exercise in Parkinson's disease on and off medication. Mov Disord. 2009 Sep 15;24(12):1773-8. doi: 10.1002/mds.22612.
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.
Other Identifiers
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BHS-797
Identifier Type: -
Identifier Source: org_study_id
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