Effect of Blueberry Supplementation on Alzheimer's Biomarkers

March 7, 2023 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 55 to 85 years old inclusive
  2. 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.
  3. Medically stable

Exclusion Criteria:

  1. Dementia
  2. Significant confounding active neurological/psychiatric disease
  3. Participation in an experimental investigational drug trial in the past 30 days
  4. Unwilling to restrict consumption of anthocyanin-rich foods
  5. Inability to complete cognitive testing (e.g. significant visual or hearing impairment)
  6. Allergy or intolerance to blueberries
  7. Significant gastrointestinal disorders or surgery that influences digestion and absorption
  8. Presence of unstable, acutely symptomatic, or life-limiting illness
  9. Women of childbearing potential

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

U.S. Highbush Blueberry Council

Investigators

  • Principal Investigator: Murali Doraiswamy, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2022

Primary Completion (Actual)

February 6, 2023

Study Completion (Actual)

February 6, 2023

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

December 28, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00108907

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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