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Completed No phase listed Observational Accepts healthy volunteers

Determination of Variances in Exhaled Nitric Oxide Output in Normal Healthy Male Volunteers Consuming High and Low Nitrate/Nitrite Diets

ClinicalTrials.gov ID: NCT00027157

Public ClinicalTrials.gov record NCT00027157. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Determination of Variances in Exhaled Nitric Oxide Output in Normal Healthy Male Volunteers Consuming High and Low Nitrate/Nitrite Diets

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will determine whether and how nitrites and nitrates in the diet affect the level of nitric oxide gas that is breathed out in air. Nitric oxide is involved in many bodily processes, such as immune function, nerve signal transmission, inflammation, and dilation of blood vessels and bronchial tubes (tubes that branch out from the trachea into the lungs). Healthy male volunteers age 18 years or older who have not smoked for at least 5 years may be eligible for this study. Candidates will undergo blood and urine tests, breathing tests, and an electrocardiogram. Participants will follow two special diets for 3 days each. One is a low-nitrate and nitrite diet, and the other is a high-nitrate and nitrite diet. Both diets must be completed within a month's time. Participants will be admitted to the NIH Clinical Center for two 3-night hospital stays during the two diet periods, but may go out on passes at any time. While on the diets, they may consume only food prepared by the NIH Nutrition Department; eating other foods will seriously affect the study results. Meals may be eaten at the NIH Clinical Center, or packaged meals prepared by the Nutrition Department can be taken out. Participants may not engage in any heavy exercise during the diet periods, as exercise affects nitric oxide levels. Blood samples of about 4 milliliters, or 1 teaspoon, each will be collected before starting each diet and at the end of each diet to measure blood levels of nitrate and nitrite. Additional blood samples, totaling about 2 tablespoons, will be collected for research. Each day, participants will have a test to measure exhaled nitric oxide levels. This involves blowing air into a mouthpiece attached to a machine that measures levels of the gas in each breath.

Study identification

NCT ID
NCT00027157
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
18 participants

Conditions and interventions

Conditions

Interventions

Not listed

Eligibility (public fields only)

Age range
Not listed
Sex
Male
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2000
Primary completion
Not listed
Completion
Mar 31, 2003
Last update posted
Mar 3, 2008

2000 – 2003

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Heart, Lung and Blood Institute (NHLBI) Bethesda Maryland 20892

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00027157, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 3, 2008 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00027157 live on ClinicalTrials.gov.

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