INTERMAP: International Population Study on Macronutrients and BP
| Tracking Information | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | May 25, 2000 | ||||||||||||||||||||||||||||||||
| Last Updated Date | October 31, 2012 | ||||||||||||||||||||||||||||||||
| Start Date ICMJE | July 1995 | ||||||||||||||||||||||||||||||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00005271 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||||||||||
| Brief Title ICMJE | INTERMAP: International Population Study on Macronutrients and BP | ||||||||||||||||||||||||||||||||
| Official Title ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| 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: 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 ICMJE | Observational | ||||||||||||||||||||||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
||||||||||||||||||||||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||||||||||||||||||||||
| Biospecimen | Retention: Samples Without DNA Description: 24 hour urine collection among all participants |
||||||||||||||||||||||||||||||||
| 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). |
||||||||||||||||||||||||||||||||
| Condition ICMJE |
|
||||||||||||||||||||||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||||||||||||||||||||||
| Publications * |
|
||||||||||||||||||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||||||||||||||||||
| Recruitment Information | |||||||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||||||||||||||||||
| Enrollment ICMJE | 4680 | ||||||||||||||||||||||||||||||||
| Estimated Completion Date | May 2014 | ||||||||||||||||||||||||||||||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | 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 |
||||||||||||||||||||||||||||||||
| Gender | Both | ||||||||||||||||||||||||||||||||
| Ages | 40 Years to 59 Years | ||||||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||
| Location Countries ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT00005271 | ||||||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 1155, R01HL050490 | ||||||||||||||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||||||||||||||
| Responsible Party | Jeremiah Stamler, Northwestern University | ||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | Northwestern University | ||||||||||||||||||||||||||||||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||||||||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||||||||||||||||||
| Information Provided By | Northwestern University | ||||||||||||||||||||||||||||||||
| Verification Date | October 2012 | ||||||||||||||||||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||||||||||||||||||