Reference Values for Plasma Catechols

Objectives: Plasma levels of catechols have distinct meanings in terms of indicating functions of endogenous catecholamine systems. This Protocol is designed to enable ongoing quality assurance of diagnostic and research assays of catechols and their metabolites and to identify possible influences of demographic and anthropometric factors, dietary constituents, and conditions of sampling on reference values.

Study Populations: The study population is healthy volunteers and people who are obese or have untreated hypertension.

Design: Arm venous blood is drawn via an indwelling i.v. catheter from healthy volunteers across demographic and anthropometric spectra (age, gender, skin color, ethnicity, body mass, adiposity), to obtain quality control plasma and establish reference values for plasma levels of catechols and their metabolites. Non-invasive physiological measures are obtained concurrently. Levels of catechols and their metabolites are related to results of common clinical pathology tests. Subgroups of subjects are tested more than once, to assess dietary influences (cereal with milk, coffee) and conditions of sampling (temperature at the skin).

Outcome Measures: The main non-experimental outcome is an ongoing pool of quality control plasma. The main experimental outcome measures are plasma concentrations of catechols and their metabolites, non-invasive physiological measures, and results of common clinical pathology tests. Subject groups are compared with respect to the above demographic and anthropometric factors. Effects of the experimental manipulations are assessed within subjects

Study Overview

Detailed Description

Objective: Plasma levels of catechols have distinct meanings in terms of indicating functions of endogenous catecholamine systems. This protocol is designed to enable ongoing quality assurance of diagnostic and research assays of catechols and their metabolites and to identify possible influences of dietary constituents and conditions of sampling.

Study Population:The study population is Healthy Volunteers (HVs).

Design: Arm venous blood is drawn via an indwelling i.v. catheter from HVs to obtain quality control plasma. Levels of catechols and their metabolites are related to dietary influences (e.g., coffee, olives, banana) and conditions of sampling (temperature at the skin) by repeated measurements in the same subjects over time.

Outcome Measures: The main non-experimental outcome is an ongoing pool of quality control plasma. The main experimental outcome measures are plasma concentrations of catechols and their metabolites and physiological measures, and results of common clinical pathology tests. Effects of the experimental manipulations are assessed within subjects.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

The subjects are healthy volunteers 18 years or older who are not pregnant or lactating.

EXCLUSION CRITERIA:

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Minors younger than 18 years old are excluded.

A candidate subject is excluded if, in the judgment of the Principal Investigator, Protocol participation would place the subject at substantially increased acute medical risk. A candidate subject is excluded if, in the opinion of the Principal Investigator, the medical risk outweighs the potential scientific benefit.

A candidate subject is excluded if there is a disqualifying condition. Examples of disqualifying conditions are hepatic failure, a history of tachyarrhythmias or heart block, symptomatic congestive heart failure, severe anemia, psychosis, refractory ventricular arrhythmias, symptomatic coronary heart disease, diabetes mellitus, or hyperthyroidism. Abnormal screening results may exclude further participation, at the discretion of the Principal Investigator.

Subjects will be excluded from further participation and referred for medical management, if the systolic blood pressure during supine rest is greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 105 mm Hg.

Alcohol use disorder.

A candidate subject is excluded if clinical considerations require that the patient continue treatment with a drug likely to interfere with the scientific results. Examples are acetaminophen, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, adrenoceptor agonists or antagonists, anticoagulants, anticonvulsants, antipsychotics, calcium channel blockers, hypoglycemic agents, digoxin, dopaminergic drugs, monoamine oxidase inhibitors, oral contraceptives, sedatives, steroids, and tricyclic antidepressants. Patients are not to discontinue any medications, just to participate in this study.

Subjects in whom we feel it would be difficult to insert a catheter into a vein may be excluded.

Pregnant or lactating women are excluded. To exclude pregnancy, women with child bearing potential have blood testing for pregnancy, with negative results obtained within 1 day of each day of testing.

Candidate subjects who admit to a history of alcohol addiction and alcohol use disorder are excluded from the study as a whole, but is especially important in the portion of the study involving ingesting red wine.

Candidate subjects who drink alcohol every day are excluded from the portion of the study involving ingesting red wine.

People with a history of sulfite allergy are excluded from the portion of the study involving ingestion of red wine.

Subjects must be at least 21 years old in order to participate in the portion of the study involving ingestion of red wine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Volunteer for Banana
Ingestion of a single banana
Banana ingestion
Experimental: Healthy Volunteer for Coffee
Ingestion of caffeinated coffee on one day and decaffeinated coffee on another day
Caffeinated coffee and decaffeinated coffee ingestion
Experimental: Healthy Volunteer for Olive
Ingestion of olives
Olives ingestion
No Intervention: Healthy Volunteer for Quality Control Plasma
Arm venous blood is drawn via an indwelling i.v. catheter from HVs to obtain quality control plasma
Experimental: Healthy Volunteer for Temp. Manip.
Manipulation of temperature at skin of the back
Manipulate temperature at skin of the back

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pool of quality control plasma
Time Frame: One time (over 1-4 outpatient visits)
The main non-experimental outcome is an ongoing pool of quality control plasma.
One time (over 1-4 outpatient visits)
Plasma concentrations of catechols and their metabolites and physiological measure
Time Frame: One time (over 1-4 outpatient visits)
The main experimental outcome measures are plasma concentrations of catechols and their metabolites and physiological measures, and results of common clinical pathology tests. Effects of the experimental manipulations are assessed within subjects.
One time (over 1-4 outpatient visits)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2006

Primary Completion (Actual)

February 20, 2020

Study Completion (Actual)

March 18, 2022

Study Registration Dates

First Submitted

December 21, 2005

First Submitted That Met QC Criteria

December 20, 2005

First Posted (Estimate)

December 21, 2005

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 25, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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