Cardiovascular DiseasesNCT00005271
INTERMAP: International Population Study on Macronutrients and BP
An observational study of Cardiovascular Diseases and Heart Diseases, run by Northwestern University.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 59 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- 4,680 participants
- Where
- No sites listed yet
- Study dates
- Jul 1995to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 59 years
- All sexes
- No healthy volunteers
- Adult
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).
Who may be able to join
- Healthy individuals
- Men and women
- Age 40-59 years
- Willing to collect 24 hour urine and return to clinic for second follow-up visit
Who cannot join
- Existing disease
- Unwilling to provide 24 hour urine collections
- Unable to attend follow-up visits
- Unable to recall dietary intake
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure measurement relative to diet.
Ongoing comparisons of different nutrients, urinary sodium and blood pressure.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1995
- Primary completionAug 2009
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 4,680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Lawrence Appel, Principal investigator, Johns Hopkins UniversityDaniel Jones, Principal investigator, University of Mississippi Medical CenterDarwin Labarthe, Principal investigator, University of TexasBeatriz Rodriguez, Principal investigator, University of Hawaii at ManoaJeremiah Stamler, Principal investigator, Northwestern UniversityLinda Van Horn, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005271
- Sponsor's protocol ID
- 1155
- Other IDs
- R01HL050490
- Status last verified
- Jan 2016
- First submitted
- 25 May 2000
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Stamler J, Elliott P, Dennis B, Dyer AR, Kesteloot H, Liu K, Ueshima H, Zhou BF; INTERMAP Research Group. INTERMAP: background, aims, design, methods, and descriptive statistics (nondietary). J Hum Hypertens. 2003 Sep;17(9):591-608. doi: 10.1038/sj.jhh.1001603.
PubMed 13679950Beevers DG, Stamler J. Background to the INTERMAP study of nutrients and blood pressure. J Hum Hypertens. 2003 Sep;17(9):589-90. doi: 10.1038/sj.jhh.1001609. No abstract available.
PubMed 13679949Dennis B, Stamler J, Buzzard M, Conway R, Elliott P, Moag-Stahlberg A, Okayama A, Okuda N, Robertson C, Robinson F, Schakel S, Stevens M, Van Heel N, Zhao L, Zhou BF; INTERMAP Research Group. INTERMAP: the dietary data--process and quality control. J Hum Hypertens. 2003 Sep;17(9):609-22. doi: 10.1038/sj.jhh.1001604.
PubMed 13679951Zhou BF, Stamler J, Dennis B, Moag-Stahlberg A, Okuda N, Robertson C, Zhao L, Chan Q, Elliott P; INTERMAP Research Group. Nutrient intakes of middle-aged men and women in China, Japan, United Kingdom, and United States in the late 1990s: the INTERMAP study. J Hum Hypertens. 2003 Sep;17(9):623-30. doi: 10.1038/sj.jhh.1001605.
PubMed 13679952Dyer AR, Elliott P, Stamler J, Chan Q, Ueshima H, Zhou BF; INTERMAP Research Group. Dietary intake in male and female smokers, ex-smokers, and never smokers: the INTERMAP study. J Hum Hypertens. 2003 Sep;17(9):641-54. doi: 10.1038/sj.jhh.1001607.
PubMed 13679954Stamler J, Elliott P, Appel L, Chan Q, Buzzard M, Dennis B, Dyer AR, Elmer P, Greenland P, Jones D, Kesteloot H, Kuller L, Labarthe D, Liu K, Moag-Stahlberg A, Nichaman M, Okayama A, Okuda N, Robertson C, Rodriguez B, Stevens M, Ueshima H, Horn LV, Zhou B. Higher blood pressure in middle-aged American adults with less education-role of multiple dietary factors: the INTERMAP study. J Hum Hypertens. 2003 Sep;17(9):655-775. doi: 10.1038/sj.jhh.1001608.
PubMed 13679955Conway R, Robertson C, Dennis B, Stamler J, Elliott P; INTERMAP Research Group. Standardised coding of diet records: experiences from INTERMAP UK. Br J Nutr. 2004 May;91(5):765-71. doi: 10.1079/BJN20041095.
PubMed 15152639Zhao L, Stamler J, Yan LL, Zhou B, Wu Y, Liu K, Daviglus ML, Dennis BH, Elliott P, Ueshima H, Yang J, Zhu L, Guo D; INTERMAP Research Group. Blood pressure differences between northern and southern Chinese: role of dietary factors: the International Study on Macronutrients and Blood Pressure. Hypertension. 2004 Jun;43(6):1332-7. doi: 10.1161/01.HYP.0000128243.06502.bc. Epub 2004 Apr 26.
PubMed 15117915Dyer AR, Greenland P, Elliott P, Daviglus ML, Claeys G, Kesteloot H, Chan Q, Ueshima H, Stamler J; INTERMAP Research Group. Estimating laboratory precision of urinary albumin excretion and other urinary measures in the International Study on Macronutrients and Blood Pressure. Am J Epidemiol. 2004 Aug 1;160(3):287-94. doi: 10.1093/aje/kwh196.
PubMed 15258002Dyer AR, Greenland P, Elliott P, Daviglus ML, Claeys G, Kesteloot H, Ueshima H, Stamler J; INTERMAP Research Group. Evaluation of measures of urinary albumin excretion in epidemiologic studies. Am J Epidemiol. 2004 Dec 1;160(11):1122-31. doi: 10.1093/aje/kwh326.
PubMed 15561992Daviglus ML, Greenland P, Stamler J, Elliott P, Appel LJ, Carnethon MR, Chan Q, Claeys G, Kesteloot H, Miura K, Nakagawa H, Pirzada A, Steffen L, Yan LL, Zhou B, Dyer AR. Relation of nutrient intake to microalbuminuria in nondiabetic middle-aged men and women: International Population Study on Macronutrients and Blood Pressure (INTERMAP). Am J Kidney Dis. 2005 Feb;45(2):256-66. doi: 10.1053/j.ajkd.2004.11.005.
PubMed 15685502Elliott P, Stamler J, Dyer AR, Appel L, Dennis B, Kesteloot H, Ueshima H, Okayama A, Chan Q, Garside DB, Zhou B. Association between protein intake and blood pressure: the INTERMAP Study. Arch Intern Med. 2006 Jan 9;166(1):79-87. doi: 10.1001/archinte.166.1.79.
PubMed 16401814Byambajav T, Chan Q, Okami Y, Kadota A, Miyagawa N, Okuda N, Nakagawa H, Sakata K, Saitoh S, Okayama A, Yoshita K, Masaki K, Lau CE, Ebbels TM, Van Horn L, Holmes E, Elliott P, Stamler J, Ueshima H, Miura K; INTERMAP/INTERLIPID Research Groups. Association between fish-related metabolites and metabolic syndrome risk factors in Japan: INTERLIPID metabolome -wide association study. Eur J Nutr. 2026 Jul 30;65(5):223. doi: 10.1007/s00394-026-04068-7.
PubMed 42530704Oude Griep LM, Chekmeneva E, Van Horn L, Chan Q, Daviglus ML, Frost G, Holmes E, Ebbels TM, Elliott P. A Metabolome Wide Association Study of Fruit and Vegetable Consumption and Associations with Cardiovascular Disease Risk Factors: The International Study of Macro-/Micronutrients and Blood Pressure (INTERMAP) Study. J Nutr. 2025 Jan;155(1):122-131. doi: 10.1016/j.tjnut.2024.11.004. Epub 2024 Nov 12.
PubMed 39536968Gibson R, Aljuraiban GS, Oude Griep LM, Vu TH, Steffen LM, Appel LJ, Rodriguez BL, Daviglus ML, Elliott P, Van Horn L, Chan Q. Relationship of calcium and magnesium intakes with the dietary approaches to stop hypertension score and blood pressure: the International Study of Macro/micronutrients and Blood Pressure. J Hypertens. 2024 May 1;42(5):789-800. doi: 10.1097/HJH.0000000000003648. Epub 2023 Dec 20.
PubMed 38164982
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTERMAP: International Population Study on Macronutrients and BP
- ClinicalTrials.gov ID
- NCT00005271
- Acronym / sponsor ID
- 1155
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,680 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 1995
- Primary completion
- Aug 2009 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (4 listed)
- Healthy individuals
- Men and women
- Age 40-59 years
- Willing to collect 24 hour urine and return to clinic for second follow-up visit
Key exclusion criteria (4 listed)
- Existing disease
- Unwilling to provide 24 hour urine collections
- Unable to attend follow-up visits
- Unable to recall dietary intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood pressure measurement relative to diet.
Time frame: 15 years
Ongoing comparisons of different nutrients, urinary sodium and blood pressure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Background: PubMed 13679950Stamler J, Elliott P, Dennis B, Dyer AR, Kesteloot H, Liu K, Ueshima H, Zhou BF; INTERMAP Research Group. INTERMAP: background, aims, design, methods, and descriptive statistics (nondietary). J Hum Hypertens. 2003 Sep;17(9):591-608. doi: 10.1038/sj.jhh.1001603.
- Background: PubMed 13679949Beevers DG, Stamler J. Background to the INTERMAP study of nutrients and blood pressure. J Hum Hypertens. 2003 Sep;17(9):589-90. doi: 10.1038/sj.jhh.1001609. No abstract available.
- Background: PubMed 13679951Dennis B, Stamler J, Buzzard M, Conway R, Elliott P, Moag-Stahlberg A, Okayama A, Okuda N, Robertson C, Robinson F, Schakel S, Stevens M, Van Heel N, Zhao L, Zhou BF; INTERMAP Research Group. INTERMAP: the dietary data--process and quality control. J Hum Hypertens. 2003 Sep;17(9):609-22. doi: 10.1038/sj.jhh.1001604.
- Background: PubMed 13679952Zhou BF, Stamler J, Dennis B, Moag-Stahlberg A, Okuda N, Robertson C, Zhao L, Chan Q, Elliott P; INTERMAP Research Group. Nutrient intakes of middle-aged men and women in China, Japan, United Kingdom, and United States in the late 1990s: the INTERMAP study. J Hum Hypertens. 2003 Sep;17(9):623-30. doi: 10.1038/sj.jhh.1001605.
- Background: PubMed 13679954Dyer AR, Elliott P, Stamler J, Chan Q, Ueshima H, Zhou BF; INTERMAP Research Group. Dietary intake in male and female smokers, ex-smokers, and never smokers: the INTERMAP study. J Hum Hypertens. 2003 Sep;17(9):641-54. doi: 10.1038/sj.jhh.1001607.
- Background: PubMed 13679955Stamler J, Elliott P, Appel L, Chan Q, Buzzard M, Dennis B, Dyer AR, Elmer P, Greenland P, Jones D, Kesteloot H, Kuller L, Labarthe D, Liu K, Moag-Stahlberg A, Nichaman M, Okayama A, Okuda N, Robertson C, Rodriguez B, Stevens M, Ueshima H, Horn LV, Zhou B. Higher blood pressure in middle-aged American adults with less education-role of multiple dietary factors: the INTERMAP study. J Hum Hypertens. 2003 Sep;17(9):655-775. doi: 10.1038/sj.jhh.1001608.
- Background: PubMed 15152639Conway R, Robertson C, Dennis B, Stamler J, Elliott P; INTERMAP Research Group. Standardised coding of diet records: experiences from INTERMAP UK. Br J Nutr. 2004 May;91(5):765-71. doi: 10.1079/BJN20041095.
- Background: PubMed 15117915Zhao L, Stamler J, Yan LL, Zhou B, Wu Y, Liu K, Daviglus ML, Dennis BH, Elliott P, Ueshima H, Yang J, Zhu L, Guo D; INTERMAP Research Group. Blood pressure differences between northern and southern Chinese: role of dietary factors: the International Study on Macronutrients and Blood Pressure. Hypertension. 2004 Jun;43(6):1332-7. doi: 10.1161/01.HYP.0000128243.06502.bc. Epub 2004 Apr 26.
- Background: PubMed 15258002Dyer AR, Greenland P, Elliott P, Daviglus ML, Claeys G, Kesteloot H, Chan Q, Ueshima H, Stamler J; INTERMAP Research Group. Estimating laboratory precision of urinary albumin excretion and other urinary measures in the International Study on Macronutrients and Blood Pressure. Am J Epidemiol. 2004 Aug 1;160(3):287-94. doi: 10.1093/aje/kwh196.
- Background: PubMed 15561992Dyer AR, Greenland P, Elliott P, Daviglus ML, Claeys G, Kesteloot H, Ueshima H, Stamler J; INTERMAP Research Group. Evaluation of measures of urinary albumin excretion in epidemiologic studies. Am J Epidemiol. 2004 Dec 1;160(11):1122-31. doi: 10.1093/aje/kwh326.
- Background: PubMed 15685502Daviglus ML, Greenland P, Stamler J, Elliott P, Appel LJ, Carnethon MR, Chan Q, Claeys G, Kesteloot H, Miura K, Nakagawa H, Pirzada A, Steffen L, Yan LL, Zhou B, Dyer AR. Relation of nutrient intake to microalbuminuria in nondiabetic middle-aged men and women: International Population Study on Macronutrients and Blood Pressure (INTERMAP). Am J Kidney Dis. 2005 Feb;45(2):256-66. doi: 10.1053/j.ajkd.2004.11.005.
- Background: PubMed 16401814Elliott P, Stamler J, Dyer AR, Appel L, Dennis B, Kesteloot H, Ueshima H, Okayama A, Chan Q, Garside DB, Zhou B. Association between protein intake and blood pressure: the INTERMAP Study. Arch Intern Med. 2006 Jan 9;166(1):79-87. doi: 10.1001/archinte.166.1.79.
Related trials for Cardiovascular Diseases
Recruiting
Efficacy and Safety of Ischemic Preconditioning Therapy Versus Optimal Medical Therapy in Reducing the Recurrence of Ischemic Events in Symptomatic Moyamoya Disease
Moya Moya Disease, Moyamoya Syndrome
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Appel principal investigator
Johns Hopkins University
Daniel Jones principal investigator
University of Mississippi Medical Center
Darwin Labarthe principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Northwestern University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure measurement relative to diet. (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005271, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.