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

New York Institute of Technology

Status and phase: Completed; Early Phase 1

Conditions: Blood Pressure

Treatments: Dietary Supplement: Sugar Pill; Dietary Supplement: L-tyrosine

Study type: Interventional

Funder types: Other

Identifiers

NCT02259049

BHS-1056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 40 to 84 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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6 participants in 2 patient groups, including a placebo group

L-Tyrosine

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: L-tyrosine

Dietary Supplement: Sugar Pill

Sugar Pill

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: L-tyrosine

Dietary Supplement: Sugar Pill