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临床试验/NCT00118846
NCT00118846已完成2 期

Phytoestrogens and Progression of Atherosclerosis

University of Southern California2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2004年4月12日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
350
试验地点
2
主要终点
Progression of Subclinical Atherosclerosis

研究概览

简要总结

The purpose of this study is to determine whether soy supplementation can reduce hardening of the arteries and cognitive decline in postmenopausal women.

详细描述

Heart disease is the leading cause of death among women in the United States. Atherosclerosis, a primary cause of heart disease, accounts for more than 485,000 heart attacks and 370,000 strokes each year in American women. Data indicate that a woman's risk of suffering from an atherosclerosis-related cardiovascular event significantly increases after menopause; this risk may be due to reduced estrogen production associated with menopause. Soy isoflavones are plant compounds that are structurally similar to human estrogen. Evidence suggests that soy supplements may provide the same protection against heart disease as estrogen in postmenopausal women. This study will determine the effects of soy supplementation on subclinical atherosclerosis progression and cognitive decline in postmenopausal women.

In this double-blinded, placebo-controlled trial, a total of 350 postmenopausal women were randomly assigned to receive either soy protein supplementation or placebo twice daily for 2.7 years. The initial 2.5-year treatment period was increased to 3 years. The active product, given as two divided doses, was 25 g soy protein containing 85 mg aglycone weight naturally-occurring isoflavones (150 mg total isoflavone) of genistein 45 mg aglycone weight (80 mg total weight), daidzein 35 mg aglycone weight (60 mg total weight), and glycitein 5 mg aglycone weight (10 mg total weight). The primary trial end point was the rate of change in the right distal common carotid artery intima-media thickness (CIMT) by ultrasonography. Participants underwent ultrasonography at baseline and every six months along with laboratory determinations and clinical measurements. Cognitive assessments were completed at baseline and the final follow-up visit (2.5 years).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal, defined as no vaginal bleeding for at least 1 year and serum estradiol level lower than 20 pg/ml

排除标准

  • Signs, symptoms or personal history of cardiovascular disease
  • Diabetes mellitus or fasting serum glucose of 126 mg/dL or greater
  • Fasting plasma triglyceride of 500 mg/dL or greater
  • Serum creatinine greater than 2.0 mg/dL
  • Uncontrolled hypertension
  • Untreated thyroid disease
  • Life expectancy less than 5 years
  • Current use of hormone replacement therapy (HRT)
  • Soy, nut, or related food allergies
  • More than 5 alcohol drinks per day or substance abuse

结局指标

主要结局

Progression of Subclinical Atherosclerosis

时间窗: Baseline x 2 and then every 6 months, up to 2.5 years

Rate of change in right distal common carotid artery (CCA) far wall intima-media thickness (um per year) in computer image processed B-mode ultrasonograms.

次要结局

  • Change in Neurocognitive Function (Global Cognition)(Baseline and 2.5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Howard N. Hodis, M.D.

Harry J. Bauer and Dorothy Bauer Rawlins Professor of Cardiology, Professor of Medicine, Population and Public Health Sciences, and Molecular Pharmacology and Toxicology, Director, Atherosclerosis Research Unit

University of Southern California

研究点 (2)

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