Completed

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

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What is being tested

Tyrosine

+ Placebo Comparator:Sugar Pill

Dietary SupplementOther
Who is being recruted

Synucleinopathies+13

+ Autonomic Nervous System Diseases

+ Basal Ganglia Diseases

From 50 to 80 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorNew York Institute of Technology
Last updated: April 16, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorNew York Institute of Technology
Last updated: April 16, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesAutonomic Nervous System DiseasesBasal Ganglia DiseasesBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesHypotensionMovement DisordersNervous System DiseasesVascular DiseasesNeurodegenerative DiseasesParkinsonian DisordersPrimary DysautonomiasOrthostatic IntoleranceHypotension, OrthostaticParkinson Disease

Criteria

5 inclusion criteria required to participate
Able to walk on a treadmill comfortably for 6-10 minutes

Currently taking levodopa

Diagnosis of PD according to the UK Brain Bank Diagnostic criteria

Diagnosis of orthostatic hypotension according to EFNS guidelines

Show More Criteria

3 exclusion criteria prevent from participating
Currently taking an amino acid supplement

Currently taking medication that affects BP

Normal BP response to testing

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Placebo
Placebo sugar pills (2x daily) for 7 days

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

New York Institue of Technology

Old Westbury, United StatesOpen New York Institue of Technology in Google Maps
CompletedOne Study Center