Effect of Blueberry Supplementation on Alzheimer's Biomarkers

Alzheimer Disease Clinical Trial

Official title:

Effect of Blueberry Supplementation on Alzheimer's Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05172128
• Other study ID #: Pro00108907
• Status: Completed
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: February 6, 2023

Study information

• Verified date: December 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 6, 2023
• Est. primary completion date: February 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Dietary Supplement:
• lyophilized blueberry supplement
lyophilized blueberry supplement bid

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	U.S. Highbush Blueberry Council

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. Erratum In: PLoS One. 2015;10(12):e0146252. Cu, Yu [corrected to Cui, Yu]. — View Citation

Outcome

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