Reference Values for Plasma Catechols

Phase 1

Completed

• Conditions: Normal Physiology; Healthy Volunteers
• Interventions: Other: Olives; Other: Coffee; Other: Temp. manip.; Other: Banana

• Registration Number: NCT00267904
• Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

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

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 Timeline

• Study First Submitted QC: 2005-12-20
• Study First Submitted: 2005-12-21
• Study First Posted: 2005-12-21
• Study Start: 2006-03-08
• Primary Completion: 2020-02-20
• Status Verified: 2022-03
• Study Completion: 2022-03-18
• Last Update Submitted: 2022-03-25
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Volunteer for Olive	Olives	Ingestion of olives
Healthy Volunteer for Coffee	Coffee	Ingestion of caffeinated coffee on one day and decaffeinated coffee on another day
Healthy Volunteer for Temp. Manip.	Temp. manip.	Manipulation of temperature at skin of the back
Healthy Volunteer for Banana	Banana	Ingestion of a single banana

Primary Outcome Measures

Name	Time	Method
Pool of quality control plasma	One time (over 1-4 outpatient visits)	The main non-experimental outcome is an ongoing pool of quality control plasma.
Plasma concentrations of catechols and their metabolites and physiological measure	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.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States