The Clinical and Physiological Effects of Blueberry Consumption in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 4
- 主要终点
- Ambulatory Blood Pressure Monitoring
研究概览
简要总结
This randomized, parallel-design trial will evaluate specific clinical and physiological effects of whole blueberries in adults 70 years of age or older.
详细描述
Although much is already known about the benefits of a healthy diet for the prevention of a wide range of chronic diseases, including the particular health benefits of anthocyanin-rich foods, these effects have been examined with much less frequency in older adults, who tend to be excluded from formal feeding studies and, until recently, have represented a small proportion of ongoing cohort studies. The proposed study will randomize approximately 46 women and 24 men, representative of the proportion of elderly women and men in the U.S. to consume either:
- 1 cup of frozen blueberries daily for 12 weeks
or 2. 2-3 dried dates daily for 12 weeks.
Dates were chosen as a control food because they contain negligible polyphenols, proportionately high caloric content, and a convenient form for storage. After the 12-week intervention, researchers will repeat in-person study assessments from baseline.
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
- 70 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •70 years old
- •Independent-living
排除标准
- •Cardiovascular event or procedure within 3 months of randomization
- •AHA Class III-IV heart failure
- •Intolerance or allergy to blueberries or dates
- •History of gastric bypass surgery
- •Any planned hospitalization or vacation in the ensuing 4 months
- •Any current cancer treatment
- •End-stage renal disease
- •Any organ transplant
- •Uncontrolled diabetes mellitus with hemoglobin A1c >9%
- •Systolic blood pressure >200 mmHg
- •Inability to provide personal informed consent (e.g. cognitive impairment)
- •Investigator concern
结局指标
主要结局
Ambulatory Blood Pressure Monitoring
时间窗: 12 weeks after randomization
24-hour wake-time ambulatory blood pressure monitoring
Lower Extremity Functioning
时间窗: 12 weeks after randomization
Short Physical Performance Battery
Cognition
时间窗: 12 weeks after randomization
Cogstate Brief Battery of four core cognitive domains: processing speed, attention, visual learning, and working memory
Orthostatic Hypotension
时间窗: 12-weeks after randomization
Supine and standing blood pressure
次要结局
- Number of Self-Reported Falls(Weekly for 12 weeks between baseline and follow-up)
- Total Cholesterol(12 weeks after randomization)
- Free Fatty Acids(12 weeks after randomization)
- Sleep(12 weeks after randomization)
- Troponin T (HS)(12 weeks after randomization)
- Derived Low Density Lipoprotein Cholesterol(12 weeks after randomization)
- Triglycerides(12 weeks after randomization)
- Grip Strength(12 weeks after randomization)
- Estimated Glomerular Filtration Rate (eGFR)(12 weeks after randomization)
- C-Reactive Protein (CRP)(12 weeks after randomization)
- Incontinence(12 weeks after randomization)
- Cardiac Ectopy(12 weeks after randomization)
- High Density Lipoprotein Cholesterol(12 weeks after randomization)
- Albumin-to-Creatinine Ratio(12 weeks after randomization)
- C-terminal telopeptide of type 1 collagen(12 weeks after randomization)
- Fructosamine(12 weeks after randomization)
- T-Cell Receptor Portfolio(12 weeks after randomization)
- Immune System Diversity(12 weeks after randomization)
研究者
Kenneth Mukamal
Associate Section Chief for Research
Beth Israel Deaconess Medical Center