Reference Values for Plasma Catechols

NCT00267904 | Completed Phase 1

• 2 other identifiers: 06004706-N-0047
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers; Normal Physiology

Keywords

Adrenaline; Normal Physiology; Catecholamines; Catechols; Sympathetic Nervous System; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (2)

• Pool of quality control plasma

  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

  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)

Study Arms (5)

Healthy Volunteer for Banana

EXPERIMENTAL

Ingestion of a single banana

Other: Banana

Healthy Volunteer for Coffee

EXPERIMENTAL

Ingestion of caffeinated coffee on one day and decaffeinated coffee on another day

Other: Coffee

Healthy Volunteer for Olive

EXPERIMENTAL

Ingestion of olives

Other: Olives

Healthy Volunteer for Quality Control Plasma

NO INTERVENTION

Arm venous blood is drawn via an indwelling i.v. catheter from HVs to obtain quality control plasma

Healthy Volunteer for Temp. Manip.

EXPERIMENTAL

Manipulation of temperature at skin of the back

Other: Temp. manip.

Interventions

Coffee OTHER

Caffeinated coffee and decaffeinated coffee ingestion

Healthy Volunteer for Coffee

Banana OTHER

Banana ingestion

Healthy Volunteer for Banana

Olives OTHER

Olives ingestion

Healthy Volunteer for Olive

Temp. manip. OTHER

Manipulate temperature at skin of the back

Healthy Volunteer for Temp. Manip.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Goldstein DS, Lenders JW, Kaler SG, Eisenhofer G. Catecholamine phenotyping: clues to the diagnosis, treatment, and pathophysiology of neurogenetic disorders. J Neurochem. 1996 Nov;67(5):1781-90. doi: 10.1046/j.1471-4159.1996.67051781.x.

  PMID: 8863481 BACKGROUND

• Eisenhofer G, Goldstein DS, Stull R, Keiser HR, Sunderland T, Murphy DL, Kopin IJ. Simultaneous liquid-chromatographic determination of 3,4-dihydroxyphenylglycol, catecholamines, and 3,4-dihydroxyphenylalanine in plasma, and their responses to inhibition of monoamine oxidase. Clin Chem. 1986 Nov;32(11):2030-3.

  PMID: 3096593 BACKGROUND

• Holmes C, Eisenhofer G, Goldstein DS. Improved assay for plasma dihydroxyphenylacetic acid and other catechols using high-performance liquid chromatography with electrochemical detection. J Chromatogr B Biomed Appl. 1994 Mar 4;653(2):131-8. doi: 10.1016/0378-4347(93)e0430-x.

  PMID: 8205240 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Interventions

Coffee

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• David S Goldstein, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2005
• First Posted: December 21, 2005
• Study Start: March 8, 2006
• Primary Completion: February 20, 2020
• Study Completion: March 18, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)