Completed

INTERMAP: International Population Study on Macronutrients and BP

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
No DNA Sample
Who is being recruted

Vascular Diseases+1

+ Cardiovascular Diseases

+ Heart Diseases

From 40 to 59 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 1995
See protocol details

Summary

Principal SponsorNorthwestern University
Last updated: January 12, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1995

Actual date on which the first participant was enrolled.

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.

NCT00005271
Principal SponsorNorthwestern University
Last updated: January 12, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4680 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 59 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Vascular DiseasesCardiovascular DiseasesHeart DiseasesHypertension

Criteria

4 inclusion criteria required to participate
Age 40-59 years

Healthy individuals

Men and women

Willing to collect 24 hour urine and return to clinic for second follow-up visit

4 exclusion criteria prevent from participating
Existing disease

Unable to attend follow-up visits

Unable to recall dietary intake

Unwilling to provide 24 hour urine collections

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers