A Randomized Controlled Trial of Whole Soy Diet in Place of Red/Processed Meat and High Fat Dairy Products on Metabolic Features in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 入组人数
- 208
- 主要终点
- Changes of metabolic components of MetS (body weight, waist circumference, blood pressure, serum lipids and fasting glucose).
研究概览
简要总结
Project title: A randomized controlled trial of whole soy diet in place of red/processed meat and high fat dairy products on metabolic features in postmenopausal women Objectives: Metabolic syndrome (MetS) is an escalating public health problem especially in postmenopausal women. Traditional whole soy foods are rich in unsaturated fats, high quality plant protein and various bioactive phytochemicals that could benefit on MetS. The aim of the study is to examine the effect of whole soy replacement diet on the features of MetS among postmenopausal women.
Hypothesis to be tested: Whole soy diet in place of red or processed meat and high fat dairy products will significantly improve metabolic features.
Design and subjects: This will be a 12-month randomized, single-blind, controlled trial among 208 postmenopausal women with high risk of MetS or early MetS.
Study instruments: After 4 weeks' run-in, participants will be randomly allocated to either of two intervention groups, whole soy replacement group or control group, each for 6 months.
Interventions: Subjects in whole soy group will be required to include 4 servings of whole soy foods (containing 25g soy protein) into their daily diet isocalorically replacing red or processed meat and high fat dairy products. Subjects in the control group will remain an usual diet.
Main outcome measures: The outcome measures will include the indices of metabolic features as well as a 10-year risk for ischemic cardiovascular disease.
Data analysis: The changes and %change of the metabolic features at 6- and 12-month will be compared among the two groups.
Expected results: Whole soy diet substitution of high saturated fat and cholesterol rich animal products will notably decrease the risk of MetS.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women aged 45~70y within 15 years after menopause;
- •Participants who meet 2 or more of the following items:
- •waist circumference WC ≥80 cm;
- •triglyceride concentration ≥1.7 mmol/l;
- •HDL-c <50 mg/dl (1.29 mmol/l);
- •SBP/DBP ≥130/85 mm Hg;
- •fasting glucose ≥5.6 mmol/l.
排除标准
- •On use of medications known to affect body weight, lipids and glucose within past 3-month;
- •Medical history or presence of severe systemic or endocrine diseases;
- •Present or history of breast, endometrial or ovarian cancer;
- •Abnormal uterine bleeding after menopause;
- •On prescribed or vegetarian diet;
- •Known soy allergy.
结局指标
主要结局
Changes of metabolic components of MetS (body weight, waist circumference, blood pressure, serum lipids and fasting glucose).
时间窗: Will be measured at baseline, 6-month and 12-month after intervention.
次要结局
- Changes of 10-year risk for ischemic cardiovascular disease (ICVD)(Will be assessed at baseline and 12-month after intervention.)
研究者
Liu Zhaomin
Research Assistant Professor
Chinese University of Hong Kong