Effect of Blueberry Supplementation on Alzheimer's Biomarkers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05172128

Enrollment

Registered

2021-12-29

Start date

2022-02-21

Completion date

2023-02-06

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Mild Cognitive Impairment

Keywords

MCI, biomarkers, memory loss

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.

Interventions

DIETARY_SUPPLEMENTlyophilized blueberry supplement

lyophilized blueberry supplement bid

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Blood Neurofilament Light (NfL) Levels as Measured by Blood Biomarker Assay	Baseline, 12 weeks	Change in NfL level from baseline to 12 weeks as measured by blood biomarker assay in pg/mL
Change in Blood Glial Fibrillary Acidic Protein (GFAP) Levels as Measured by Blood Biomarker Assay	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
Change in Blood Amyloid Beta 42/40 as Measured by Blood Biomarker Assay	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.
Change in P-tau 181 as Measured by Blood Biomarker Assay	Baseline, 12 weeks	Change in p-tau 181 from baseline to 12 weeks as measured by blood biomarker assay in pg/mL
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)	Baseline, 12 weeks	Change in brain-derived neurotrophic factor (BDNF) from baseline to 12 weeks in pg/mL

Countries

United States

Participant flow

Participants by arm

Arm	Count
Single Arm Blueberry Supplementation single arm blueberry supplementation	10
Total	10

Baseline characteristics

Characteristic	Single Arm Blueberry Supplementation
Age, Continuous	80.20 years STANDARD_DEVIATION 5.16
Education	18.10 years STANDARD_DEVIATION 2.15
Mini-Mental State Examination (MMSE)	27.20 units on a scale STANDARD_DEVIATION 2.15
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	10 Participants
Region of Enrollment United States	10 Participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	10 Participants
Weschler Logical Memory Delay	4.80 units on a scale STANDARD_DEVIATION 3.43

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 10
other Total, other adverse events	5 / 10
serious Total, serious adverse events	1 / 10

Outcome results

Primary

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.