Effects of Blueberry Consumption on Cardiometabolic Parameters in Men With Type 2 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Blood Pressure
研究概览
简要总结
Lifestyle strategies that include dietary modification, such as consumption of a plant-based diet, are well recognized in disease prevention and may improve type 2 diabetes. Various components of a plant-based diet may contribute to its beneficial health effects, but there has been keen interest in the possibility that plant polyphenols may have a role. Blueberries are dietary sources of polyphenols, specifically anthocyanins. To date there are few human clinical trials evaluating the beneficial health effects of blueberries in populations with type 2 diabetes. The objective of the study is to determine if freeze-dried blueberries compared to a blueberry placebo will improve cardiometabolic parameters in men with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ages 45 to 75 years at beginning of study
- •BMI >25 kg/m2
- •HbA1C > 6.5 and < 9
- •Medical diagnosis of type 2 diabetes for at least 6 months
排除标准
- •Use of insulin
- •Presence of chronic kidney disease (GFR < 45 mL/min), liver cirrhosis, gastrointestinal disease, pancreatic disease, or malabsorption syndromes
- •Weight loss of >10% of body weight over the last 6 months; routine participation in heavy exercise
- •Heavy smokers (>20 cigarettes per day)
- •Unable or unwilling to give informed consent or communicate with study staff
- •Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigators may interfere with study participation or the ability to follow the intervention protocol
- •Allergies to blueberries or blueberry products
结局指标
主要结局
Blood Pressure
时间窗: 8 weeks
Systolic blood pressure and diastolic blood pressure.
次要结局
- Hemoglobin A1C(8 weeks)