Healthy VolunteersPhase 1NCT00267904

Reference Values for Plasma Catechols

A Phase 1 study testing Coffee, Banana and Olives in people with Healthy Volunteers and Normal Physiology, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Normal Physiology
What is being tested?: Coffee, Banana and Olives
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteUnited States
Study dates: 8 Mar 2006to 18 Mar 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

<TAB>
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.

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Healthy Volunteers, Normal Physiology
Being tested: Coffee, Banana, Olives, Temp. manip.
Keywords: Adrenaline, Normal Physiology, Catecholamines, Catechols, Sympathetic Nervous System, Healthy Volunteer, HV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CoffeeOther
Caffeinated coffee and decaffeinated coffee ingestion
BananaOther
Banana ingestion
OlivesOther
Olives ingestion
Temp. manip.Other
Manipulate temperature at skin of the back

Study groups in NCT00267904
Study group	Role	What they receive
Healthy Volunteer for Banana	Experimental	Ingestion of a single banana Receives: Other: Banana
Healthy Volunteer for Coffee	Experimental	Ingestion of caffeinated coffee on one day and decaffeinated coffee on another day Receives: Other: Coffee
Healthy Volunteer for Olive	Experimental	Ingestion of olives Receives: 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 Receives: Other: Temp. manip.

What is being measured

The primary outcome is the main question the study is designed to answer.

Pool of quality control plasma
The main non-experimental outcome is an ongoing pool of quality control plasma.
Measured: 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.
Measured: One time (over 1-4 outpatient visits)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Mar 200618 Mar 2022

First posted21 Dec 2005 (estimated)
Study start8 Mar 2006
Primary completion20 Feb 2020
Study completion18 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00267904
Sponsor's protocol ID: 060047
Other IDs: 06-N-0047
Status last verified: Mar 2022
First submitted: 21 Dec 2005
Last updated: 29 Mar 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 8863481
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.
PubMed 3096593
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.
PubMed 8205240

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reference Values for Plasma Catechols
ClinicalTrials.gov ID: NCT00267904
Acronym / sponsor ID: 060047
Conditions: Healthy Volunteers, Normal Physiology
Keywords: Adrenaline, Normal Physiology, Catecholamines, Catechols, Sympathetic Nervous System, Healthy Volunteer, HV
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
Study start: 8 Mar 2006 (actual)
Primary completion: 20 Feb 2020 (actual)
Study completion: 18 Mar 2022 (actual)
First posted: 21 Dec 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

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 design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Healthy Volunteer for Banana	Experimental	Other: BananaIngestion of a single banana
Healthy Volunteer for Coffee	Experimental	Other: CoffeeIngestion of caffeinated coffee on one day and decaffeinated coffee on another day
Healthy Volunteer for Olive	Experimental	Other: OlivesIngestion of 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	Other: Temp. manip.Manipulation of temperature at skin of the back

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (13 listed)

<TAB>
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CoffeeCaffeinated coffee and decaffeinated coffee ingestion	Other	Healthy Volunteer for Coffee
BananaBanana ingestion	Other	Healthy Volunteer for Banana
OlivesOlives ingestion	Other	Healthy Volunteer for Olive
Temp. manip.Manipulate temperature at skin of the back	Other	Healthy Volunteer for Temp. Manip.

Primary outcome

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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
Background: PubMed 8863481Goldstein 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.
Background: PubMed 3096593Eisenhofer 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.
Background: PubMed 8205240Holmes 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.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David S Goldstein, M.D. principal investigator

National Institute of Neurological Disorders and Stroke (NINDS)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pool of quality control plasma (time frame: One time (over 1-4 outpatient visits)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00267904, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.