A Randomized Controlled Trial to Determine the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Whole Soy: a Dose Response Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 243
- 试验地点
- 6
- 主要终点
- Low Density Lipoprotein Cholesterol (LDL-Cholesterol)
研究概览
简要总结
This study is being conducted to test the hypothesis that daily consumption of a baked food product containing whole soy for 6 weeks will significantly reduce plasma Low Density Lipoprotein Cholesterol (LDL-C) in individuals with hypercholesterolemia. As such the overall goals of this study are to determine whether daily consumption of muffins made from whole soy flour for 6 weeks can lower plasma LDL-Cholesterol, and if so, establish whether the effect is dose-dependent. To do this, study collaborators will: (1) conduct a detailed chemical and physical characterization of certified defatted whole soy flour that will be incorporated into a muffin; (2) formulate and produce a palatable whole soy flour muffin along with a control muffin containing wheat flour; (3) conduct a parallel controlled trial in which soy muffins will be fed randomly to persons with elevated LDL-cholesterol in a human clinical trial. All participants will be randomized into one of three groups and asked to eat two muffins daily for 6 weeks in the following combination: high dose soy; control group or low dose soy. Before, after, and mid-way during the feeding period, blood samples will be obtained for measurements of lipids, glucose, insulin, inflammation, and soy phytochemicals. The effect of soy consumption on waist circumference, body mass index (BMI) and blood pressure will also be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females (not pregnant or lactating) aged 30-70 year
- •Body mass index (BMI) ≤40kg/m² and ≥18.5kg/m²
- •Fasting plasma total cholesterol ≥5.0
- •Fasting plasma LDL cholesterol ≥3.0 and <5.0 mmol/L.
排除标准
- •Fasting plasma triglycerides ≥4.0 mmol/L
- •Abnormal liver and kidney function
- •Unstable body weight(>3kg change in 3 months) or intention to lose or gain weight;
- •Diabetes mellitus (fasting plasma glucose ≥7.0 mmol/L or use of insulin or any hypoglycemic or anti-hyperglycemic medication);
- •Use of any prescription or non-prescription drug, prebiotics or probiotics, herbal or nutritional supplement known to affect blood lipids, except for stable doses (no change in 3 months) of thyroxine, oral contraceptive agents, hormone replacement therapy, and medications for controlling blood pressure);
- •Major surgical or medical events within the past 3 months;
- •Presence of a gastrointestinal disorder or medication that alters the digestion and absorption of nutrients; including antibiotic use within the past 6 weeks.
- •Consumption of a diet containing ≥15% of energy from saturated fat;
- •Any food allergy or aversion or unwillingness to eat wheat, soy or milk;
- •Consumption of ≥5 servings per week of soy based food products;
- •Consumption of an average of >2 alcoholic beverages per day;
- •Regular smokers (smoking ≥1 cigarette per day) of cigarettes or cigars
研究组 & 干预措施
Control
- Isocaloric control muffins
干预措施: Standardized soy containing muffin (Other)
Low Dose Soy
- Isocaloric muffins containing low dose of soy
干预措施: Standardized soy containing muffin (Other)
High Dose Soy
- Isocaloric muffins containing high dose soy
干预措施: Standardized soy containing muffin (Other)
结局指标
主要结局
Low Density Lipoprotein Cholesterol (LDL-Cholesterol)
时间窗: 6 weeks
次要结局
- high sensitivity c-reactive protein (hsCRP)(6 weeks)
研究者
Dan Ramdath
Principal Investigator
Guelph Food Research Centre