HealthyNCT00027157
Determination of Variances in Exhaled Nitric Oxide Output in Normal Healthy Male Volunteers Consuming High and Low Nitrate/Nitrite Diets
An observational study of Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2000to Apr 2003
- Phase
- Observational
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Inclusion criteria for research volunteers include (1) male; (2) good overall health history without any recent (3 months) acute disease; (3) physical examination within normal limits; (4) laboratory evaluation; including complete blood count (CBC), acute care panel, clotting times, chest x-ray (only if medically indicated), pulmonary function testing and an electrocardiogram (EKG)-within normal limits; (5) non-smokers defined as having never smoked or not smoked within the past 5 or more years; (6) willingness to commit to the three day strict low NO(2)/NO(3) diet and three day high NO(2)/NO(3) diet prepared by the Nutrition Department and supplied as either hot meals or pre-packaged meals; and (7) willingness to avoid intensive exercise, e.g., running, jogging, aerobics, etc., during the entire study.
Who cannot join
- Exclusion criteria include (1) age less than 18; (2) females; (3) positive serum test for hepatitis virus; and (4) inability to complete reliable pulmonary function tests.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: The Determination of Variances in Exhaled Nitric Oxide Output in Normal Healthy Male Volunteers Consuming High and Low Nitrate/Nitrite Diets
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.
Read more
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.
Read the detailed description
Nitric oxide (NO) has been recognized for its multifaceted roles in many physiological processes (e.g., vasodilatation, host defense, neurotransmission, bronchodilatation, and inflammation.) NO is produced by a family of nitric oxide synthase (NOS) isoforms in a reaction that converts L-arginine to L-citrulline. NO metabolites in vivo include nitrite (NO2) and nitrate (NO3). Plasma NO2/NO3 concentrations have been used extensively as a marker for NOS activity and NO radical production. Studies have shown that dietary intake of nitrate, estrogen, atmospheric pollution, and heavy exercise can influence NO2/NO3 levels in blood. NO can also be detected in exhaled air. NO levels vary with disease, and in some cases (e.g., asthma) respond to treatment (e.g., steroid).
This pilot study is designed to determine whether or not dietary intake influences exhaled NO levels. To use plasma metabolite measurements to monitor NOS activity, subjects must adhere to a strict low NO2/NO3 diet before and during the study where measurements of exhaled NO can be performed quickly and easily in an inpatient setting. Subjects will be studied as inpatients consuming standardized high and low nitrite/nitrate (NO2/NO3) diets each for a period of three days. Since L-arginine is a NOS substrate and can affect the generation of NO, diets will also be monitored by protein intake. Blood samples will be collected four times during the study, pre- and post-diet for each diet, for the quantification of NO2/NO3 concentration. Exhaled NO will be measured daily. In addition, blood pressure, pulmonary function testing, and blood plasma levels of L-arginine, cyclic guanosine monophosphate (cGMP), and S-thiolation may be monitored. Results of this study should allow us to determine the most effective method of monitoring NOS activity, and potentially identify activities responsible for maintaining nitric oxide levels.
- Conditions
- Healthy
- Keywords
- Coronary Spasm, Endothelial-Derived-Relaxation Factor, Nitric Oxide Synthase, Susceptibility Genes, Tetrahydrobiopterin
- Medical subject headings
- Angina Pectoris, Variant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2001 (estimated)
- Study startApr 2000
- Study completionApr 2003
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 HealthyStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 18 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027157
- Sponsor's protocol ID
- 000118
- Other IDs
- 00-H-0118
- Status last verified
- Apr 2003
- First submitted
- 27 Nov 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Bauer JA, Wald JA, Doran S, Soda D. Endogenous nitric oxide in expired air: effects of acute exercise in humans. Life Sci. 1994;55(24):1903-9. doi: 10.1016/0024-3205(94)00522-2.
PubMed 7990650Barnes PJ, Belvisi MG. Nitric oxide and lung disease. Thorax. 1993 Oct;48(10):1034-43. doi: 10.1136/thx.48.10.1034. No abstract available.
PubMed 7903007Akar N, Akar E, Cin S, Deda G, Avcu F, Yalcin A. Endothelial nitric oxide synthase intron 4, 27 bp repeat polymorphism in Turkish patients with deep vein thrombosis and cerebrovascular accidents. Thromb Res. 1999 Apr 1;94(1):63-4. doi: 10.1016/s0049-3848(98)00193-5. No abstract available.
PubMed 10213182
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Determination of Variances in Exhaled Nitric Oxide Output in Normal Healthy Male Volunteers Consuming High and Low Nitrate/Nitrite Diets
- ClinicalTrials.gov ID
- NCT00027157
- Acronym / sponsor ID
- 000118
- Conditions
- Healthy
- Keywords
- Coronary Spasm, Endothelial-Derived-Relaxation Factor, Nitric Oxide Synthase, Susceptibility Genes, Tetrahydrobiopterin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 2000
- Study completion
- Apr 2003
- First posted
- 28 Nov 2001 (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.
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.
Detailed description
Nitric oxide (NO) has been recognized for its multifaceted roles in many physiological processes (e.g., vasodilatation, host defense, neurotransmission, bronchodilatation, and inflammation.) NO is produced by a family of nitric oxide synthase (NOS) isoforms in a reaction that converts L-arginine to L-citrulline. NO metabolites in vivo include nitrite (NO2) and nitrate (NO3). Plasma NO2/NO3 concentrations have been used extensively as a marker for NOS activity and NO radical production. Studies have shown that dietary intake of nitrate, estrogen, atmospheric pollution, and heavy exercise can influence NO2/NO3 levels in blood. NO can also be detected in exhaled air. NO levels vary with disease, and in some cases (e.g., asthma) respond to treatment (e.g., steroid).
This pilot study is designed to determine whether or not dietary intake influences exhaled NO levels. To use plasma metabolite measurements to monitor NOS activity, subjects must adhere to a strict low NO2/NO3 diet before and during the study where measurements of exhaled NO can be performed quickly and easily in an inpatient setting. Subjects will be studied as inpatients consuming standardized high and low nitrite/nitrate (NO2/NO3) diets each for a period of three days. Since L-arginine is a NOS substrate and can affect the generation of NO, diets will also be monitored by protein intake. Blood samples will be collected four times during the study, pre- and post-diet for each diet, for the quantification of NO2/NO3 concentration. Exhaled NO will be measured daily. In addition, blood pressure, pulmonary function testing, and blood plasma levels of L-arginine, cyclic guanosine monophosphate (cGMP), and S-thiolation may be monitored. Results of this study should allow us to determine the most effective method of monitoring NOS activity, and potentially identify activities responsible for maintaining nitric oxide levels.
Study design
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria for research volunteers include (1) male; (2) good overall health history without any recent (3 months) acute disease; (3) physical examination within normal limits; (4) laboratory evaluation; including complete blood count (CBC), acute care panel, clotting times, chest x-ray (only if medically indicated), pulmonary function testing and an electrocardiogram (EKG)-within normal limits; (5) non-smokers defined as having never smoked or not smoked within the past 5 or more years; (6) willingness to commit to the three day strict low NO(2)/NO(3) diet and three day high NO(2)/NO(3) diet prepared by the Nutrition Department and supplied as either hot meals or pre-packaged meals; and (7) willingness to avoid intensive exercise, e.g., running, jogging, aerobics, etc., during the entire study.
Key exclusion criteria (1 listed)
- Exclusion criteria include (1) age less than 18; (2) females; (3) positive serum test for hepatitis virus; and (4) inability to complete reliable pulmonary function tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 7990650Bauer JA, Wald JA, Doran S, Soda D. Endogenous nitric oxide in expired air: effects of acute exercise in humans. Life Sci. 1994;55(24):1903-9. doi: 10.1016/0024-3205(94)00522-2.
- Background: PubMed 7903007Barnes PJ, Belvisi MG. Nitric oxide and lung disease. Thorax. 1993 Oct;48(10):1034-43. doi: 10.1136/thx.48.10.1034. No abstract available.
- Background: PubMed 10213182Akar N, Akar E, Cin S, Deda G, Avcu F, Yalcin A. Endothelial nitric oxide synthase intron 4, 27 bp repeat polymorphism in Turkish patients with deep vein thrombosis and cerebrovascular accidents. Thromb Res. 1999 Apr 1;94(1):63-4. doi: 10.1016/s0049-3848(98)00193-5. No abstract available.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
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 1 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 4 Mar 2008. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00027157, 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 4 Mar 2008.