NCT02259049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Oct 2014

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

October 3, 2014

Last Update Submit

January 19, 2016

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    24 hours

Secondary Outcomes (1)

  • Heart Rate

    24 hours

Study Arms (2)

L-Tyrosine

ACTIVE COMPARATOR

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

Dietary Supplement: L-tyrosineDietary Supplement: Sugar Pill

Sugar Pill

PLACEBO COMPARATOR

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

Dietary Supplement: L-tyrosineDietary Supplement: Sugar Pill

Interventions

L-tyrosineDIETARY_SUPPLEMENT

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

L-TyrosineSugar Pill
Sugar PillDIETARY_SUPPLEMENT

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

L-TyrosineSugar Pill

Eligibility Criteria

Age40 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • between 35 and 79 years of age
  • mentally able to participate in the study
  • Pregnancy
  • any person who is currently taking amino acid supplements.
  • Any history of myocardial infarction, stent, or CABG
  • Phenylketonurics
  • Untreated hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Institute of Technology

Old Westbury, New York, 11758, United States

Location

MeSH Terms

Interventions

TyrosineSugars

Intervention Hierarchy (Ancestors)

Amino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsCarbohydrates

Study Officials

  • Joanne Donoghue, PhD

    New York Institute of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 8, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 20, 2016

Record last verified: 2014-09

Locations

US(1)