Integrated Cardiovascular and Metabolic Effects of Strawberry Consumption in Overweight and Obese Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in plasma lipids
研究概览
简要总结
Our proposal represents an integrated approach to determining the cardiovascular and metabolic effects of strawberry consumption in adults who have high risk for cardiometabolic disease.
详细描述
The current proposal aims to fill some of these important research gaps with regard the dose and time-course of strawberry consumption in a population where dietary intervention may of particular benefit for both primary and secondary prevention of cardiovascular and metabolic disease. Participants will participate in a double blind, placebo-controlled, randomized crossover trial. Following a 10-day run-in where no berries are consumed, participants will be randomized via Latin-square design, to three different daily strawberry powder conditions for 4-weeks at a time, with a 7 day washout between conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
The supplement and placebo will be distributed to the individual by a member of the research team who is not involved with data collection or analysis.
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight or obese by BMI (25.0-34.9kg/m2),
- •Borderline-high LDL-cholesterol (130-159mg/dL),
- •Normal or elevated blood pressure ((≤129mmHg/≤80mmHg)
排除标准
- •known allergy or intolerance to strawberries
- •taking any medications for chronic diseases including anti-inflammatory, anti-hypertensive, lipid-lowering, glucose-controlling, or steroidal medications
- •taking any supplements that might affect outcomes of the study including anti-oxidant or fish-oil supplements
- •having anemia or any liver, thyroid, renal conditions
- •current smoker or user of tobacco products, or use within the past three months
- •consuming alcohol (>1-2 drinks/day) on a regular basis
- •currently pregnant or lactating
- •having elevated blood pressure ≥130mmHg/≥80mmHg
- •presence of diagnosed diabetes mellitus, inflammatory disease, atherosclerotic disease, or other relevant chronic conditions
- •total cholesterol ≥240mg/dL
- •hemoglobin normal range values for males (between 13.0-17.5g/dL) and females (between 12.5-15.5g/dL)
结局指标
主要结局
Change in plasma lipids
时间窗: Week 0, 4, 5, 9, 10, and 14
Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal
次要结局
- Change in blood pressure (resting and 24-hr)(Week 0, 4, 5, 9, 10, and 14)
- Change in glucose and insulin response(Week 0, 4, 5, 9, 10, and 14)
- Change in homeostatic model assessment for insulin resistance(Week 0, 4, 5, 9, 10, and 14)
- Change in endothelial function(Week 0, 4, 5, 9, 10, and 14)
- Change in inflammation(Week 0, 4, 5, 9, 10, and 14)
- Change in arterial stiffness(Week 0, 4, 5, 9, 10, and 14)
- Change in oxidixed LDL(Week 0, 4, 5, 9, 10, and 14)
研究者
Carl Ade, M.S., Ph.D.
Co-Principal Investigator
Kansas State University