Effect of Blueberry Supplementation on Alzheimer's Biomarkers

NCT05172128 | Completed Results

• 1 other identifier: Pro00108907
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease

Keywords

MCI; biomarkers; memory loss

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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.

  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

  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)

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

  Baseline, 12 weeks

Study Arms (1)

Blueberry supplementation

EXPERIMENTAL

All participants will receive 18 grams lyophilized blueberry supplement mixed with water twice daily for 12 weeks.

Dietary Supplement: lyophilized blueberry supplement

Interventions

lyophilized blueberry supplement DIETARY_SUPPLEMENT

lyophilized blueberry supplement bid

Blueberry supplementation

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• U.S. Highbush Blueberry Council: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (5)

• Miller MG, Hamilton DA, Joseph JA, Shukitt-Hale B. Dietary blueberry improves cognition among older adults in a randomized, double-blind, placebo-controlled trial. Eur J Nutr. 2018 Apr;57(3):1169-1180. doi: 10.1007/s00394-017-1400-8. Epub 2017 Mar 10.

  PMID: 28283823 BACKGROUND

• Wang S, Cui Y, Wang C, Xie W, Ma L, Zhu J, Zhang Y, Dang R, Wang D, Wu Y, Wu Q. Protective Effects of Dietary Supplementation with a Combination of Nutrients in a Transgenic Mouse Model of Alzheimer's Disease. PLoS One. 2015 Nov 25;10(11):e0143135. doi: 10.1371/journal.pone.0143135. eCollection 2015.

  PMID: 26606074 BACKGROUND

• Jeong HR, Jo YN, Jeong JH, Kim HJ, Kim MJ, Heo HJ. Blueberry (Vaccinium virgatum) leaf extracts protect against Abeta-induced cytotoxicity and cognitive impairment. J Med Food. 2013 Nov;16(11):968-76. doi: 10.1089/jmf.2013.2881. Epub 2013 Oct 11.

  PMID: 24117094 BACKGROUND

• Brewer GJ, Torricelli JR, Lindsey AL, Kunz EZ, Neuman A, Fisher DR, Joseph JA. Age-related toxicity of amyloid-beta associated with increased pERK and pCREB in primary hippocampal neurons: reversal by blueberry extract. J Nutr Biochem. 2010 Oct;21(10):991-8. doi: 10.1016/j.jnutbio.2009.08.005. Epub 2009 Dec 1.

  PMID: 19954954 BACKGROUND

• Ou Y, Hu H, Wang Z, Xu W, Tan L, et al. Plasma neurofilament light as a longitudinal biomarker of neurodegeneration in Alzheimer's disease. Brain Science Advances. 2019;5(2):94-105.

  BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Memory Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. P. Murali Doraiswamy
• Organization: Duke University Medical Center

murali.doraiswamy@duke.edu

9196845933

Study Officials

• Murali Doraiswamy, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 29, 2021
• Study Start: February 21, 2022
• Primary Completion: February 6, 2023
• Study Completion: February 6, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)