Effect of Soy Nuts on Blood Pressure, Lipids and Inflammation in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
To determine the effect of a whole soy food, dietary soy nuts, on blood pressure, lipid levels, inflammation and menopausal symptoms in postmenopausal women.
详细描述
The present study examines the effect of a whole soy food, soy nuts (dry roasted soybeans), added to the Therapeutic Lifestyle Change diet on blood pressure, lipids, inflammation and menopausal symptoms in postmenopausal hypertensive and normotensive women in a randomized crossover trial during an 8-week period. We sought to determine whether dietary soy had an additional benefit to the currently recommended heart healthy diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with absence of menses for at least 12 months or irregular periods and hot flashes.
排除标准
- •were current cigarette smoking or smoking in the previous year;
- •clinical coronary artery disease, peripheral artery disease, or cerebrovascular disease;
- •known diabetes mellitus or a fasting glucose level of 126 mg/dL or greater;
- •a history of breast cancer; a fasting triglyceride level greater than 400 mg/dL; systolic BP of 165 mm Hg or greater or diastolic BP of 100 mm Hg or greater;
- •untreated hypothyroidism; systemic or endocrine disease known to affect lipid, mineral, or bone metabolism;
- •and consumption of more than 21 alcoholic drinks per week.
- •Use of lipid-lowering drugs, hormone therapy, medications for osteoporosis, and soy products was discontinued for 2 months before entering the study. Participants took a multivitamin but no additional vitamin or mineral supplements or other soy products during the study.
研究组 & 干预措施
soy nuts
25 g of soy nuts provided daily to the subjects and they were counseled to replace 25 g of protein in their therapeutic lifestyle change (TLC) diet with the soy. TLC diet consisted of 30% of energy from total fat (<7% saturated fat, 12% monounsaturated fat and 11% polyunsaturated fat), 15% from protein and 55% from carbohydrate; less than 200 mg of cholesterol per day and 1200 mg of calcium and 2 fatty fish meals per week. Those ingesting suboptimal dietary calcium were given calcium carbonate supplementation.
干预措施: soy nuts (Other)
Therapeutic lifestyle change diet
Counseling on therapeutic lifestyle change diet consisting of 30% of energy from total fat (<7% saturated fat, 12% monounsaturated fat and 11% polyunsaturated fat), 15% from protein and 55% from carbohydrate; less than 200 mg of cholesterol per day and 1200 mg of calcium and 2 fatty fish meals per week. Those ingesting suboptimal dietary calcium were given calcium carbonate supplementation.
干预措施: soy nuts (Other)
结局指标
主要结局
Blood pressure
时间窗: 8 weeks
stratified by hypertensive status (normal BP, prehypertension, hypertension)
次要结局
- lipid levels(8 weeks)
- menopausal symptoms(8 weeks)
- inflammatory markers(8 weeks)