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

The Effects of L-Tyrosine on Non-invasive Ambulatory Blood Pressure and Heart Rate Monitoring in Parkinson's Disease

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Dietary supplement: L-tyrosine; Dietary supplement: Sugar Pill

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Old Westbury, New York, United States, 11758
      • New York Institute of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: L-Tyrosine; We will administer 1,000 mg of L-tyrosine BID for 24 hours and record BP and HR.	Dietary supplement: L-tyrosine; Each subject will receive 2,000 mg of L-tyrosine BID for 24 hours.; Dietary supplement: Sugar Pill; Each subject will receive a sugar pill BID for 24 hours.
Placebo Comparator: Sugar Pill; We will administer a sugar pill BID for 24 hours and record BP and HR.	Dietary supplement: L-tyrosine; Each subject will receive 2,000 mg of L-tyrosine BID for 24 hours.; Dietary supplement: Sugar Pill; Each subject will receive a sugar pill BID for 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood Pressure	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart Rate	24 hours

Collaborators and Investigators

• Sponsor: New York Institute of Technology

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 3, 2014
• First Submitted That Met QC Criteria: October 7, 2014
• First Posted (Estimate): October 8, 2014

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: BHS-1056