Effects of Replacing Starchy Vegetables and Refined Grains With Beef in a Vegetarian Diet on Cardio-metabolic Disease Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Concentrations of serum lipids, lipoproteins, and total apolipoprotein B
研究概览
简要总结
The purpose of this study is to assess the effects of replacing starchy vegetables and refined grains with beef in a vegetarian diet on cardio-metabolic disease risk factors in adults in a cross-over, randomized controlled feeding trial.
详细描述
The purpose of this study is to assess the effects of replacing starchy vegetables and refined grains with beef in a vegetarian diet on cardio-metabolic disease risk factors in adults in a cross-over, randomized controlled feeding trial. The hypothesis is that isocalorically replacing predominantly starchy vegetables and refined grains with 6 oz. of beef/day will enhance improvements in cardiometabolic disease risk factors, particularly atherosclerotic-promoting lipids and lipoproteins. It is also hypothesized that participant satisfaction and acceptance of a healthy eating pattern with 6 oz. of beef per day will be higher compared to without beef.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •30-69 years old
- •BMI 25-37 kg/m2
- •Total cholesterol <260 mg/dL
- •Low-density lipoprotein cholesterol <190 mg/dL
- •Glucose <110 mg/dL
- •Systolic/diastolic blood pressure < 140/90
- •Body weight stable for 3 months prior (±3 kg)
- •Stable physical activity regimen 3 months prior
- •Medication use stable for 6 months prior
- •Non-smoking
- •Not drinking more than 2 alcoholic drinks per day
- •Non-diabetic
- •Not lactose-intolerant
- •Not acutely ill
- •Non-pregnant and not lactating.
- •Participants must be willing and able to consume the prescribed diets (lacto-ovo vegetarian and omnivorous).
排除标准
- •<30 or >69 years old
- •BMI <25.0 or >37 kg/m2
- •Fasting serum total cholesterol > 260 mg/dL
- •Low-density lipoprotein cholesterol >189 mg/dL
- •Glucose >110 mg/dL
- •Systolic/diastolic blood pressure > 140/90
- •Body weight stable for <3 months prior (±3 kg)
- •Stable physical activity regimen < 3 months prior
- •Medication use unstable for 6 months prior and using medications
- •Drinking more than 2 alcoholic drinks per day
- •Have renal failure
- •Have liver failure
- •Have cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study
- •Pregnant or lactating
研究组 & 干预措施
Controlled healthy vegetarian diet
Subjects will be randomized and assigned to consume the controlled Healthy Vegetarian Eeating Pattern for 5 weeks.
干预措施: Controlled healthy vegetarian diet (Other)
Controlled beef diet
Subjects will be randomized and assigned to consume the beef diet for 5 weeks, which will substitute predominantly starchy vegetables and refined grains with 6 oz. of lean unprocessed beef/day.
干预措施: Controlled beef diet (Other)
结局指标
主要结局
Concentrations of serum lipids, lipoproteins, and total apolipoprotein B
时间窗: 1.5 years
The hypothesis is that substituting starchy vegetables and refined grain with lean unprocessed beef in a plant based eating pattern will result in greater reduction in the concentrations of low-density lipoprotein-cholesterol, total cholesterol, triglycerides, and total apolipoprotein B, but greater increase in concentration of high-density lipoprotein-cholesterol.
次要结局
- Level of fasting blood pressure(1.5 years)
- Concentration of fasting serum glucose(1.5 years)
- Level of fasting serum insulin(1.5 years)
- Size of lipoprotein particle(1.5 years)
研究者
Wayne Campbell
Principal Investigator
Purdue University