Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027157
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-11-27
Brief Title:
Determination of Variances in Exhaled Nitric Oxide Output in Normal Healthy Male Volunteers Consuming High and Low NitrateNitrite Diets
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Determination of Variances in Exhaled Nitric Oxide Output in Normal Healthy Male Volunteers Consuming High and Low NitrateNitrite Diets
Status:
COMPLETED
Status Verified Date:
2003-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 months 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
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 months 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 eg 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 NO2NO3 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 NO2NO3 levels in blood NO can also be detected in exhaled air NO levels vary with disease and in some cases eg asthma respond to treatment eg 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 NO2NO3 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 nitritenitrate NO2NO3 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 NO2NO3 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
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 NO2NO3 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 nitritenitrate NO2NO3 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 NO2NO3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-H-0118 | None | None | None |