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临床试验/NCT00005271
NCT00005271已完成不适用

INTERMAP: International Population Study on Macronutrients and BP

Northwestern University0 个研究点目标入组 4,680 人开始时间: 1995年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,680
主要终点
Blood pressure measurement relative to diet.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy individuals
  • Men and women
  • Age 40-59 years
  • Willing to collect 24 hour urine and return to clinic for second follow-up visit

排除标准

  • Existing disease
  • Unwilling to provide 24 hour urine collections
  • Unable to attend follow-up visits
  • Unable to recall dietary intake

结局指标

主要结局

Blood pressure measurement relative to diet.

时间窗: 15 years

Ongoing comparisons of different nutrients, urinary sodium and blood pressure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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