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The Effects of L-Tyrosine on 24 Hour Blood Pressure and Heart Rate in Parkinson's Disease

Primary Purpose

Blood Pressure

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
L-tyrosine
Sugar Pill
Sponsored by
New York Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Pressure

Eligibility Criteria

40 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. All subjects must have a diagnosis of PD by a licensed neurologist according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (UKPDBB).(Goetz, 2010) The UKPDBB is a 3 step diagnostic tool which defines inclusion and exclusion criteria for diagnosing PD
  2. between 35 and 79 years of age
  3. mentally able to participate in the study

Exclusion Criteria:

  1. Pregnancy
  2. any person who is currently taking amino acid supplements.
  3. Any history of myocardial infarction, stent, or CABG
  4. Phenylketonurics
  5. Untreated hypertension

Sites / Locations

  • New York Institute of Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

L-Tyrosine

Sugar Pill

Arm Description

We will administer 1,000 mg of L-tyrosine BID for 24 hours and record BP and HR.

We will administer a sugar pill BID for 24 hours and record BP and HR.

Outcomes

Primary Outcome Measures

Blood Pressure

Secondary Outcome Measures

Heart Rate

Full Information

First Posted
October 3, 2014
Last Updated
January 19, 2016
Sponsor
New York Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02259049
Brief Title
The Effects of L-Tyrosine on 24 Hour Blood Pressure and Heart Rate in Parkinson's Disease
Official Title
The Effects of L-Tyrosine on Non-invasive Ambulatory Blood Pressure and Heart Rate Monitoring in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Institute of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are observing the effects 2,000 mg of L-tyrosine will have on 24 hour blood pressure fluctuations in individuals with Parkinson's disease.
Detailed Description
We will be monitoring 24 hour ambulatory BP and HR in subjects with PD on 3 separate visits. The first visit will be without an intervention to establish a baseline of 24 hour BP fluctuations. One week later the subject will be given either L-tyrosine (2,000 mg) with B6 (10 mg) or a sugar pill. We will monitor 24 hour BP and HR after supplementation. One week later the subject will repeat the same procedures with either supplement or placebo. This is a total of 3 visits with 24 hour ambulatory BP and HR monitoring.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L-Tyrosine
Arm Type
Active Comparator
Arm Description
We will administer 1,000 mg of L-tyrosine BID for 24 hours and record BP and HR.
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
We will administer a sugar pill BID for 24 hours and record BP and HR.
Intervention Type
Dietary Supplement
Intervention Name(s)
L-tyrosine
Intervention Description
Each subject will receive 2,000 mg of L-tyrosine BID for 24 hours.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sugar Pill
Intervention Description
Each subject will receive a sugar pill BID for 24 hours.
Primary Outcome Measure Information:
Title
Blood Pressure
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Heart Rate
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All subjects must have a diagnosis of PD by a licensed neurologist according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (UKPDBB).(Goetz, 2010) The UKPDBB is a 3 step diagnostic tool which defines inclusion and exclusion criteria for diagnosing PD between 35 and 79 years of age mentally able to participate in the study Exclusion Criteria: Pregnancy any person who is currently taking amino acid supplements. Any history of myocardial infarction, stent, or CABG Phenylketonurics Untreated hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Donoghue, PhD
Organizational Affiliation
New York Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Institute of Technology
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11758
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effects of L-Tyrosine on 24 Hour Blood Pressure and Heart Rate in Parkinson's Disease

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