Long-term Effects of Blueberry Supplementation on Brain Health in Older Adults: a Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change in plasma concentration of neurofilament light (NFL) between baseline and 24 weeks
研究概览
简要总结
This study will test whether consuming blueberry powder 20g/d for 24 weeks can improve memory and other cognitive function and alter serum biomarkers of brain injury among older adults.
详细描述
In a randomized, double-blind placebo, controlled design, the investigators will test the effects of 20 g/d of blueberry powder for 24 weeks on cognitive function and serum biomarkers of brain injury among older adults.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 99 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 65-99 years
- •Able to travel to Brigham and Women's Hospital for 4 clinic visits
排除标准
- •Known allergies to blueberries
- •Unable to abstain from blueberry consumption during the study period
- •Inability to provide informed consent
- •Planned major surgery during study period or recent major surgery up to 3 months before recruitment
- •Organ transplant
- •Plan to move out of greater Boston area during the study period
- •Diagnosis of dementia, severe cognitive decline, end-stage renal disease, substance abuse, insulin-dependent diabetes mellitus, major cancer excluding non-melanoma skin cancer, and schizophrenia.
研究组 & 干预措施
Blueberry group
Blueberry arm
干预措施: Blueberry powder (Dietary Supplement)
Control group
Control arm
干预措施: Controlled and matched powder (Other)
结局指标
主要结局
Change in plasma concentration of neurofilament light (NFL) between baseline and 24 weeks
时间窗: Baseline and at 24 weeks after the intervention
Change will be calculated as difference between plasma NFL concentration measured at 24 weeks and NFL concentration measured at baseline.
Change in plasma concentration of phosphorylated tau (pTau-181) between baseline and 24 weeks
时间窗: Baseline and at 24 weeks post intervention
Change will be calculated as difference between plasma pTau-181 concentration measured at 24 weeks and plasma concentration of pTau-181 measured at baseline
次要结局
- Change in plasma concentration of glial fibrillary acid protein (GFAB) between baseline and 24 weeks(Baseline and at 24 weeks post intervention)
- Change in concentration of serum non-esterified fatty acids (NEFA) between baseline and 24 weeks(Baseline and 24 weeks post intervention)
- Change in cognitive battery test score between baseline and 24 weeks post intervention(Baseline and at 24 weeks post intervention)
研究者
Luc Djousse, MD, ScD, MPH
Lead Investigator and Director of Research
Brigham and Women's Hospital