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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
lyophilized blueberry supplement bid
Duke University Medical Center
Durham, North Carolina, United States
Change in Blood Neurofilament Light (NfL) Levels as Measured by Blood Biomarker Assay
Change in NfL level from baseline to 12 weeks as measured by blood biomarker assay in pg/mL
Time frame: Baseline, 12 weeks
Change in Blood Glial Fibrillary Acidic Protein (GFAP) Levels as Measured by Blood Biomarker Assay
Change in blood glial fibrillary acidic protein (GFAP) levels from baseline to 12 weeks as measured by blood biomarker assay in pg/mL
Time frame: Baseline, 12 weeks
Change in Blood Amyloid Beta 42/40 as Measured by Blood Biomarker Assay
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.
Time frame: Baseline, 12 weeks
Change in P-tau 181 as Measured by Blood Biomarker Assay
Change in p-tau 181 from baseline to 12 weeks as measured by blood biomarker assay in pg/mL
Time frame: Baseline, 12 weeks
Change in Blood Interleukin-6 (IL-6) Levels as Measured by Blood Biomarker Assay
Time frame: Baseline, 12 weeks
Change in Tumor Necrosis Factor (TNF-alpha) Levels as Measured by Blood Biomarker Assay
Time frame: Baseline, 12 weeks
Change in Brain-derived Neurotrophic Factor (BDNF)
Change in brain-derived neurotrophic factor (BDNF) from baseline to 12 weeks in pg/mL
Time frame: Baseline, 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.