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

Early Phase 1

Completed

• Conditions: Blood Pressure
• Interventions: Dietary Supplement: L-tyrosine; Dietary Supplement: Sugar Pill

• Registration Number: NCT02259049
• Lead Sponsor: New York Institute of Technology

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.

Study Timeline

• Status Verified: 2014-09
• Study Start: 2014-10
• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-08
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
L-Tyrosine	Sugar Pill	We will administer 1,000 mg of L-tyrosine BID for 24 hours and record BP and HR.
Sugar Pill	L-tyrosine	We will administer a sugar pill BID for 24 hours and record BP and HR.
L-Tyrosine	L-tyrosine	We will administer 1,000 mg of L-tyrosine BID for 24 hours and record BP and HR.
Sugar Pill	Sugar Pill	We will administer a sugar pill BID for 24 hours and record BP and HR.

Primary Outcome Measures

Name	Time	Method
Blood Pressure	24 hours

Secondary Outcome Measures

Name	Time	Method
Heart Rate	24 hours

Trial Locations

Locations (1)

New York Institute of Technology; 🇺🇸 Old Westbury, New York, United States