INTERMAP: International Population Study on Macronutrients and BP
|ClinicalTrials.gov Identifier: NCT00005271|
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : January 12, 2016
|Condition or disease|
|Cardiovascular Diseases Heart Diseases Hypertension|
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.
INTERMAP's cross-sectional design is patterned after the tested INTERSALT model: a large sample size of 4,680 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 polyunsaturated/saturated 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 Minnesota's 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 Type :||Observational|
|Actual Enrollment :||4680 participants|
|Official Title:||INTERMAP: International Population Study on Macronutrients and BP|
|Study Start Date :||July 1995|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||May 2015|
- Blood pressure measurement relative to diet. [ Time Frame: 15 years ]Ongoing comparisons of different nutrients, urinary sodium and blood pressure.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005271
|Principal Investigator:||Lawrence Appel||Johns Hopkins University|
|Principal Investigator:||Daniel Jones||University of Mississippi Medical Center|
|Principal Investigator:||Darwin Labarthe||University of Texas|
|Principal Investigator:||Beatriz Rodriguez||University of Hawaii at Manoa|
|Principal Investigator:||Jeremiah Stamler||Northwestern University|
|Principal Investigator:||Linda Van Horn||Northwestern University|