Cardiovascular DiseasesNCT00006406
Amino Acids in Urine, Diet, and Blood Pressure: International Population Study
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To analyze the relationship of dietary variables to urinary excretion of amino acids and the relationships of specific urinary amino acids to blood pressure. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 2000to Jul 2005
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To analyze the relationship of dietary variables to urinary excretion of amino acids and the relationships of specific urinary amino acids to blood pressure.
Read the detailed description
BACKGROUND:
The study analyzes data from the INTERMAP study, an international, cooperative, 17-sample population study of 4,706 men and women ages 40-59 in the United States, the United Kingdom, China, and Japan. It will provide the largest amount of data available on the patterns of urinary amino acid excretion. It will also make it possible to determine if the excretion of specific amino acids are related to the intake of dietary protein from specific food sources. Furthermore, it will provide the ability to test the hypotheses that intake of dietary protein is related to levels of both systolic and diastolic blood pressure. These hypotheses are strongly held in Japan, one of the countries participating in the INTERMAP study, and have only been investigated to a limited degree in the United States and Europe.
DESIGN NARRATIVE:
The purpose of the study was to analyze data from the INTERMAP Study, an international, cooperative, 17-sample population study of 4,706 men and women ages 40-59 in four countries including the United States, the United Kingdom, China, and Japan. Analyses assessed the following: whether, independent of multiple possible confounding variables, there were significant relationships of dietary protein (total, animal, vegetable) and of dietary specific amino acids (AA) to 24-hour urinary excretion of total and individual AA and related compounds; systolic and diastolic blood pressure (BP) of individuals were related to their 24-hour urinary excretion of taurine -- a possible marker of fish protein intake; 1-methylhistidine, 3-methylhistidine, histidine, lysine, anserine (1-methylhistidine-B-alanine dipeptide) -- reflecting meat protein intake; arginine -- source in cells for nitric oxide (NO), implicated in vasodilation; other urinary amino acids.
INTERMAP has already collected standardized comprehensive dietary and blood pressure data on all individuals in its 17 samples (four 24-hour dietary recalls/person yielding data on 60+ nutrients, including 19 amino acids, two 24-hour urine specimens/person with data on Na, K, urea N, creatinine, volume; eight standardized systolic blood pressure/diastolic blood pressure measurements/person; other data). Urinary concentrations of amino acids were analyzed chromatographically by high performance automatic amino acid analyzers in the INTEPMAP Central Laboratory in Leuven, Belgium. Regression coefficients for amino acid-blood pressure relationships were computed without and with correction for reliability (regression-dilution bias); sample-by-sample with pooling by country, region, and then overall; also by gender; for persons not on antihypertensive treatment; nonhypertensives; those free of a history of recent diet change; by education; to evaluate comprehensively whether urinary amino acid excretion could add meaningfully to dietary data to give a better total understanding of relationships of dietary protein-amino acids to blood pressure.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2000 (estimated)
- Study startAug 2000
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 National Heart, Lung, and Blood Institute (NHLBI)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Martha Daviglus, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006406
- Sponsor's protocol ID
- 931
- Other IDs
- R01HL065461
- Status last verified
- Dec 2005
- First submitted
- 12 Oct 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Dyer 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 15258002Daviglus 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 15685502Dyer 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 15561992
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acids in Urine, Diet, and Blood Pressure: International Population Study
- ClinicalTrials.gov ID
- NCT00006406
- Acronym / sponsor ID
- 931
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 2000
- Study completion
- Jul 2005 (actual)
- First posted
- 13 Oct 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 analyze the relationship of dietary variables to urinary excretion of amino acids and the relationships of specific urinary amino acids to blood pressure.
Detailed description
BACKGROUND:
The study analyzes data from the INTERMAP study, an international, cooperative, 17-sample population study of 4,706 men and women ages 40-59 in the United States, the United Kingdom, China, and Japan. It will provide the largest amount of data available on the patterns of urinary amino acid excretion. It will also make it possible to determine if the excretion of specific amino acids are related to the intake of dietary protein from specific food sources. Furthermore, it will provide the ability to test the hypotheses that intake of dietary protein is related to levels of both systolic and diastolic blood pressure. These hypotheses are strongly held in Japan, one of the countries participating in the INTERMAP study, and have only been investigated to a limited degree in the United States and Europe.
DESIGN NARRATIVE:
The purpose of the study was to analyze data from the INTERMAP Study, an international, cooperative, 17-sample population study of 4,706 men and women ages 40-59 in four countries including the United States, the United Kingdom, China, and Japan. Analyses assessed the following: whether, independent of multiple possible confounding variables, there were significant relationships of dietary protein (total, animal, vegetable) and of dietary specific amino acids (AA) to 24-hour urinary excretion of total and individual AA and related compounds; systolic and diastolic blood pressure (BP) of individuals were related to their 24-hour urinary excretion of taurine -- a possible marker of fish protein intake; 1-methylhistidine, 3-methylhistidine, histidine, lysine, anserine (1-methylhistidine-B-alanine dipeptide) -- reflecting meat protein intake; arginine -- source in cells for nitric oxide (NO), implicated in vasodilation; other urinary amino acids.
INTERMAP has already collected standardized comprehensive dietary and blood pressure data on all individuals in its 17 samples (four 24-hour dietary recalls/person yielding data on 60+ nutrients, including 19 amino acids, two 24-hour urine specimens/person with data on Na, K, urea N, creatinine, volume; eight standardized systolic blood pressure/diastolic blood pressure measurements/person; other data). Urinary concentrations of amino acids were analyzed chromatographically by high performance automatic amino acid analyzers in the INTEPMAP Central Laboratory in Leuven, Belgium. Regression coefficients for amino acid-blood pressure relationships were computed without and with correction for reliability (regression-dilution bias); sample-by-sample with pooling by country, region, and then overall; also by gender; for persons not on antihypertensive treatment; nonhypertensives; those free of a history of recent diet change; by education; to evaluate comprehensively whether urinary amino acid excretion could add meaningfully to dietary data to give a better total understanding of relationships of dietary protein-amino acids to blood pressure.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 16 Mar 2016.
- 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 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 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.
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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.
Martha Daviglus
Northwestern University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Mar 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006406, which also lists 3 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 16 Mar 2016.