Effect of Blueberry Supplementation on Alzheimer's Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Blood Neurofilament Light (NfL) Levels as Measured by Blood Biomarker Assay
研究概览
简要总结
The purpose of this study is to study the effects of blueberries on neuronal, glial, and pathology blood biomarkers in Mild Cognitive Impairment (MCI) and to estimate sample size for future confirmatory studies. The blood biomarkers to be measured are Neurofilament light (NfL), glial fibrillary acidic protein (GFAP), Aß40, Aß42, p-tau181, and cytokines, using an ultra-sensitive state-of-the-art immunoassay.
详细描述
After determining subject eligibility and after subjects have abstained from consuming all berry fruits (including red wine) for 2 weeks, subjects will have blood drawn for biomarkers and will then will undergo 12 weeks of blueberry supplementation in the form of 18 grams lyophilized blueberry powder mixed with water and taken twice daily with meals. All subjects will be asked to abstain from berry fruits (including red wine) for the duration of the 12 week trial. Subjects will receive telephone calls at 4 and 8 weeks to check compliance as well as concomitant medications and adverse events and then all subjects will return at 12 weeks for a repeat biomarker blood draw. Plasma NfL, GFAP, Aβ40, Aβ42, p-tau181, and cytokine biomarker assays will be done using the Quanterix SR-X instrument, a new, state-of-the-art digital immunoassay platform employing Simoa technology, which enables the detection and quantification of biomarkers previously difficult or impossible to measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55 to 85 years old inclusive
- •Meets criteria for amnestic Mild Cognitive Impairment defined by education adjusted performance on the Wechsler Memory Scale (WMS) III Logical Memory delayed recall score and clinical evaluation.
- •Medically stable
排除标准
- •Significant confounding active neurological/psychiatric disease
- •Participation in an experimental investigational drug trial in the past 30 days
- •Unwilling to restrict consumption of anthocyanin-rich foods
- •Inability to complete cognitive testing (e.g. significant visual or hearing impairment)
- •Allergy or intolerance to blueberries
- •Significant gastrointestinal disorders or surgery that influences digestion and absorption
- •Presence of unstable, acutely symptomatic, or life-limiting illness
- •Women of childbearing potential
结局指标
主要结局
Change in Blood Neurofilament Light (NfL) Levels as Measured by Blood Biomarker Assay
时间窗: Baseline, 12 weeks
Change in NfL level from baseline to 12 weeks as measured by blood biomarker assay in pg/mL
Change in Blood Glial Fibrillary Acidic Protein (GFAP) Levels as Measured by Blood Biomarker Assay
时间窗: Baseline, 12 weeks
Change in blood glial fibrillary acidic protein (GFAP) levels from baseline to 12 weeks as measured by blood biomarker assay in pg/mL
Change in Blood Amyloid Beta 42/40 as Measured by Blood Biomarker Assay
时间窗: Baseline, 12 weeks
Change in blood Amyloid beta 42/40 ratio (Aβ42 divided by Aβ40) from baseline to 12 weeks as measured by blood biomarker assay. Lower ratios increase likelihood of AD pathology.
Change in P-tau 181 as Measured by Blood Biomarker Assay
时间窗: Baseline, 12 weeks
Change in p-tau 181 from baseline to 12 weeks as measured by blood biomarker assay in pg/mL
Change in Blood Interleukin-6 (IL-6) Levels as Measured by Blood Biomarker Assay
时间窗: Baseline, 12 weeks
Change in Tumor Necrosis Factor (TNF-alpha) Levels as Measured by Blood Biomarker Assay
时间窗: Baseline, 12 weeks
Change in Brain-derived Neurotrophic Factor (BDNF)
时间窗: Baseline, 12 weeks
Change in brain-derived neurotrophic factor (BDNF) from baseline to 12 weeks in pg/mL
次要结局
未报告次要终点