Ignite Creation Date:
2024-05-06 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05172128
Status:
COMPLETED
Last Update Posted:
2023-03-09
First Post:
2021-12-09
Brief Title:
Effect of Blueberry Supplementation on Alzheimers Biomarkers
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Effect of Blueberry Supplementation on Alzheimers Biomarkers
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None