Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006406
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-10-12
Brief Title:
Amino Acids in Urine Diet and Blood Pressure International Population Study
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-12
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:
To analyze the relationship of dietary variables to urinary excretion of amino acids and the relationships of specific urinary amino acids to blood pressure
Detailed Description:
BACKGROUND
The study analyzes data from the INTERMAP study an international cooperative 17-sample population study of 4706 men and women ages 40-59 in the United States the United Kingdom China and Japan It will provide the largest amount of data available on the patterns of urinary amino acid excretion It will also make it possible to determine if the excretion of specific amino acids are related to the intake of dietary protein from specific food sources Furthermore it will provide the ability to test the hypotheses that intake of dietary protein is related to levels of both systolic and diastolic blood pressure These hypotheses are strongly held in Japan one of the countries participating in the INTERMAP study and have only been investigated to a limited degree in the United States and Europe
DESIGN NARRATIVE
The purpose of the study was to analyze data from the INTERMAP Study an international cooperative 17-sample population study of 4706 men and women ages 40-59 in four countries including the United States the United Kingdom China and Japan Analyses assessed the following whether independent of multiple possible confounding variables there were significant relationships of dietary protein total animal vegetable and of dietary specific amino acids AA to 24-hour urinary excretion of total and individual AA and related compounds systolic and diastolic blood pressure BP of individuals were related to their 24-hour urinary excretion of taurine -- a possible marker of fish protein intake 1-methylhistidine 3-methylhistidine histidine lysine anserine 1-methylhistidine-B-alanine dipeptide -- reflecting meat protein intake arginine -- source in cells for nitric oxide NO implicated in vasodilation other urinary amino acids
INTERMAP has already collected standardized comprehensive dietary and blood pressure data on all individuals in its 17 samples four 24-hour dietary recallsperson yielding data on 60 nutrients including 19 amino acids two 24-hour urine specimensperson with data on Na K urea N creatinine volume eight standardized systolic blood pressurediastolic blood pressure measurementsperson other data Urinary concentrations of amino acids were analyzed chromatographically by high performance automatic amino acid analyzers in the INTEPMAP Central Laboratory in Leuven Belgium Regression coefficients for amino acid-blood pressure relationships were computed without and with correction for reliability regression-dilution bias sample-by-sample with pooling by country region and then overall also by gender for persons not on antihypertensive treatment nonhypertensives those free of a history of recent diet change by education to evaluate comprehensively whether urinary amino acid excretion could add meaningfully to dietary data to give a better total understanding of relationships of dietary protein-amino acids to blood pressure
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The study analyzes data from the INTERMAP study an international cooperative 17-sample population study of 4706 men and women ages 40-59 in the United States the United Kingdom China and Japan It will provide the largest amount of data available on the patterns of urinary amino acid excretion It will also make it possible to determine if the excretion of specific amino acids are related to the intake of dietary protein from specific food sources Furthermore it will provide the ability to test the hypotheses that intake of dietary protein is related to levels of both systolic and diastolic blood pressure These hypotheses are strongly held in Japan one of the countries participating in the INTERMAP study and have only been investigated to a limited degree in the United States and Europe
DESIGN NARRATIVE
The purpose of the study was to analyze data from the INTERMAP Study an international cooperative 17-sample population study of 4706 men and women ages 40-59 in four countries including the United States the United Kingdom China and Japan Analyses assessed the following whether independent of multiple possible confounding variables there were significant relationships of dietary protein total animal vegetable and of dietary specific amino acids AA to 24-hour urinary excretion of total and individual AA and related compounds systolic and diastolic blood pressure BP of individuals were related to their 24-hour urinary excretion of taurine -- a possible marker of fish protein intake 1-methylhistidine 3-methylhistidine histidine lysine anserine 1-methylhistidine-B-alanine dipeptide -- reflecting meat protein intake arginine -- source in cells for nitric oxide NO implicated in vasodilation other urinary amino acids
INTERMAP has already collected standardized comprehensive dietary and blood pressure data on all individuals in its 17 samples four 24-hour dietary recallsperson yielding data on 60 nutrients including 19 amino acids two 24-hour urine specimensperson with data on Na K urea N creatinine volume eight standardized systolic blood pressurediastolic blood pressure measurementsperson other data Urinary concentrations of amino acids were analyzed chromatographically by high performance automatic amino acid analyzers in the INTEPMAP Central Laboratory in Leuven Belgium Regression coefficients for amino acid-blood pressure relationships were computed without and with correction for reliability regression-dilution bias sample-by-sample with pooling by country region and then overall also by gender for persons not on antihypertensive treatment nonhypertensives those free of a history of recent diet change by education to evaluate comprehensively whether urinary amino acid excretion could add meaningfully to dietary data to give a better total understanding of relationships of dietary protein-amino acids to blood pressure
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL065461 | NIH | None | httpsreporternihgovquickSearchR01HL065461 |