INTERMAP: International Population Study on Macronutrients and BP

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeremiah Stamler, Northwestern University
ClinicalTrials.gov Identifier:
NCT00005271
First received: May 25, 2000
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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.


Condition
Cardiovascular Diseases
Heart Diseases
Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Biospecimen Retention:   Samples Without DNA

24 hour urine collection among all participants


Enrollment: 4680
Study Start Date: July 1995
Estimated Study Completion Date: May 2014
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The INTERMAP study population includes 4,680 men and women ages 40-59 who were recruited from 17 population samples of diverse ethnicity/ SES/ eating practices in four countries (China, Japan, UK, USA).

Criteria

Healthy individuals Men and Women Age 40-59 years old Willing to collect 24 hour urine and return to clinic for a second follow up visit

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005271

Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Lawrence Appel Johns Hopkins University
Principal Investigator: Arlene Caggiula University of Pittsburgh
Principal Investigator: Patricia Elmer University of Minnesota - Clinical and Translational Science Institute
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeremiah Stamler, Professor Emeritus Department of Preventive Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT00005271     History of Changes
Other Study ID Numbers: 1155, R01HL050490
Study First Received: May 25, 2000
Last Updated: October 31, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014