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Completed

NCT Number: NCT05172128

Effect of Blueberry Supplementation on Alzheimer's Biomarkers

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lyophilized blueberry supplement

Dietary Supplement

lyophilized blueberry supplement bid

Primary outcomes

  1. Change in Blood Neurofilament Light (NfL) Levels as Measured by Blood Biomarker Assay

    Time frame: Baseline, 12 weeks

    Change in NfL level from baseline to 12 weeks as measured by blood biomarker assay in pg/mL

  2. Change in Blood Glial Fibrillary Acidic Protein (GFAP) Levels as Measured by Blood Biomarker Assay

    Time frame: 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

  3. Change in Blood Amyloid Beta 42/40 as Measured by Blood Biomarker Assay

    Time frame: 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.

  4. Change in P-tau 181 as Measured by Blood Biomarker Assay

    Time frame: Baseline, 12 weeks

    Change in p-tau 181 from baseline to 12 weeks as measured by blood biomarker assay in pg/mL

  5. Change in Blood Interleukin-6 (IL-6) Levels as Measured by Blood Biomarker Assay

    Time frame: Baseline, 12 weeks

  6. Change in Tumor Necrosis Factor (TNF-alpha) Levels as Measured by Blood Biomarker Assay

    Time frame: Baseline, 12 weeks

  7. Change in Brain-derived Neurotrophic Factor (BDNF)

    Time frame: Baseline, 12 weeks

    Change in brain-derived neurotrophic factor (BDNF) from baseline to 12 weeks in pg/mL

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • U.S. Highbush Blueberry Council

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 29, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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