Effect of Blueberry Supplementation on Alzheimer's Biomarkers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Blueberry Supplementation on Alzheimer's Biomarkers

Conditions
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Mild Cognitive Impairment, Alzheimer Disease

Intervention / Treatment
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* Dietary Supplement: lyophilized blueberry supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Dementia 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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blueberry supplementation<br>All participants will receive 18 grams lyophilized blueberry supplement mixed with water twice daily for 12 weeks. | Dietary Supplement: lyophilized blueberry supplement<br>* lyophilized blueberry supplement bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood Neurofilament light (NfL) levels as measured by blood biomarker assay |  | Baseline, 12 weeks | 
| Change in blood glial fibrillary acidic protein (GFAP) levels as measured by blood biomarker assay |  | Baseline, 12 weeks | 
| Change in blood Amyloid beta 40/42 as measured by blood biomarker assay |  | Baseline, 12 weeks | 
| Change in p-tau 181 as measured by blood biomarker assay |  | Baseline, 12 weeks | 
| Change in blood interleukin-6 (IL-6) levels as measured by blood biomarker assay |  | Baseline, 12 weeks | 
| Change in tumor necrosis factor (TNF-alpha) levels as measured by blood biomarker assay |  | Baseline, 12 weeks | 
| Change in brain-derived neurotrophic factor (BDNF) |  | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCI, biomarkers, memory loss