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

NCT ID: NCT02259049

Last Updated: 2016-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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L-Tyrosine

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

Group Type ACTIVE_COMPARATOR

L-tyrosine

Intervention Type DIETARY_SUPPLEMENT

Each subject will receive 2,000 mg of L-tyrosine BID for 24 hours.

Sugar Pill

Intervention Type DIETARY_SUPPLEMENT

Each subject will receive a sugar pill BID for 24 hours.

Sugar Pill

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

Group Type PLACEBO_COMPARATOR

L-tyrosine

Intervention Type DIETARY_SUPPLEMENT

Each subject will receive 2,000 mg of L-tyrosine BID for 24 hours.

Sugar Pill

Intervention Type DIETARY_SUPPLEMENT

Each subject will receive a sugar pill BID for 24 hours.

Interventions

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L-tyrosine

Each subject will receive 2,000 mg of L-tyrosine BID for 24 hours.

Intervention Type DIETARY_SUPPLEMENT

Sugar Pill

Each subject will receive a sugar pill BID for 24 hours.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Exclusion Criteria

2. between 35 and 79 years of age
3. mentally able to participate in the study


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
Minimum Eligible Age

40 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Joanne DiFrancisco-Donoghue

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joanne Donoghue, PhD

Role: PRINCIPAL_INVESTIGATOR

New York Institute of Technology

Locations

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New York Institute of Technology

Old Westbury, New York, United States

Site Status

Countries

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United States

Other Identifiers

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BHS-1056

Identifier Type: -

Identifier Source: org_study_id

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