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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

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.

  1. First posted13 Oct 2000 (estimated)
  2. Study startAug 2000
  3. Study completionJul 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
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 15258002
  • Daviglus 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 15685502
  • Dyer 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

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.

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