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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259049
• Other study ID #: BHS-1056
• Status: Completed
• Phase: Phase 0
• First received: October 3, 2014
• Last updated: January 19, 2016
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2014
• Source: New York Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 84 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Pressure
• Parkinson Disease

Intervention

Dietary Supplement:
• L-tyrosine
Each subject will receive 2,000 mg of L-tyrosine BID for 24 hours.
• Sugar Pill
Each subject will receive a sugar pill BID for 24 hours.

Locations

Country	Name	City	State
United States	New York Institute of Technology	Old Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure		24 hours	No
Secondary	Heart Rate		24 hours	No