Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005271
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2000-05-25
Brief Title:
INTERMAP International Population Study on Macronutrients and BP
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
INTERMAP International Population Study on Macronutrients and BP
Status:
COMPLETED
Status Verified Date:
2016-01
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 investigate the relationship between dietary factors especially macronutrients and blood pressure in an international multicenter observational study A particular focus is to help elucidate the role of these dietary factors in accounting for the even more adverse blood pressure patterns of less educated population strata especially in the United States in both less educated Blacks and whites
Detailed Description:
BACKGROUND
Overall study findings are to be used to estimate favorable impact on blood pressure of multiple improvements in nutrition by populations The investigators state that this should aid in making additional dietary recommendations toward the goal of primary prevention of hypertension and shifting blood pressure distributions downward to avoid excess risk associated with present levels generally above optimal
DESIGN NARRATIVE
INTERMAPs cross-sectional design is patterned after the tested INTERSALT model a large sample size of 4680 persons half men and half women ages 40-59 from 17 population samples of varied ethnicity socioeconomic status SES and dietary habits in four countries China Japan United Kingdom and the United States There were eight United States INTERMAP centers Specific aims involve elucidating influences on blood pressure of the amount and type of protein lipids carbohydrates and also amino acids calcium magnesium antioxidants fiber and caffeine Primary hypotheses tested with control for body mass index BMI intake of alcohol age sex and other confounders are as follow dietary protein is inversely related to blood pressure inverse relations between education and blood pressure are significantly accounted for by education-related differences in dietary protein intake there is a direct relation to blood pressure of dietary saturated fatty acids cholesterol Keys score starch there is an inverse relation of polyunsaturated fatty acids and polyunsaturatedsaturated fatty acids Randomly selected participants provide one timed 24-hr urine collection for assessment of sodium potassium creatine and urea and complete four 24-hr dietary recalls Blood pressure was measured eight times at each of four clinic visits with standardization and strict quality control of all procedures
The study is coordinated by two Coordinating Centers--Northwestern University Chicago and London School of Hygiene Tropical Medicine Urinary determinations are made at a Central Laboratory in Leuven Belgium Twenty-four hour dietary recalls are converted into nutrients with use of the Nutrition Data System of the University of Minnesotas Nutrition Coordinating Center Data analyses to test hypotheses are done at the London Coordinating Center
Recruitment and data collection began in July 1996 through January 1997 The main statistical analytic method is multivariate regression analysis The study was renewed in FY 2000 and in FY 2004 to continue analysis of the data through August 2009
Overall study findings are to be used to estimate favorable impact on blood pressure of multiple improvements in nutrition by populations The investigators state that this should aid in making additional dietary recommendations toward the goal of primary prevention of hypertension and shifting blood pressure distributions downward to avoid excess risk associated with present levels generally above optimal
DESIGN NARRATIVE
INTERMAPs cross-sectional design is patterned after the tested INTERSALT model a large sample size of 4680 persons half men and half women ages 40-59 from 17 population samples of varied ethnicity socioeconomic status SES and dietary habits in four countries China Japan United Kingdom and the United States There were eight United States INTERMAP centers Specific aims involve elucidating influences on blood pressure of the amount and type of protein lipids carbohydrates and also amino acids calcium magnesium antioxidants fiber and caffeine Primary hypotheses tested with control for body mass index BMI intake of alcohol age sex and other confounders are as follow dietary protein is inversely related to blood pressure inverse relations between education and blood pressure are significantly accounted for by education-related differences in dietary protein intake there is a direct relation to blood pressure of dietary saturated fatty acids cholesterol Keys score starch there is an inverse relation of polyunsaturated fatty acids and polyunsaturatedsaturated fatty acids Randomly selected participants provide one timed 24-hr urine collection for assessment of sodium potassium creatine and urea and complete four 24-hr dietary recalls Blood pressure was measured eight times at each of four clinic visits with standardization and strict quality control of all procedures
The study is coordinated by two Coordinating Centers--Northwestern University Chicago and London School of Hygiene Tropical Medicine Urinary determinations are made at a Central Laboratory in Leuven Belgium Twenty-four hour dietary recalls are converted into nutrients with use of the Nutrition Data System of the University of Minnesotas Nutrition Coordinating Center Data analyses to test hypotheses are done at the London Coordinating Center
Recruitment and data collection began in July 1996 through January 1997 The main statistical analytic method is multivariate regression analysis The study was renewed in FY 2000 and in FY 2004 to continue analysis of the data through August 2009
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 |
|---|---|---|---|
| R01HL050490 | NIH | None | httpsreporternihgovquickSearchR01HL050490 |