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| Name | Class |
|---|---|
| U.S. Highbush Blueberry Council | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blueberry supplementation | Experimental | All participants will receive 18 grams lyophilized blueberry supplement mixed with water twice daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lyophilized blueberry supplement | Dietary Supplement | lyophilized blueberry supplement bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murali Doraiswamy, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28283823 | Background | 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. | |
| 26606074 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Blueberry Supplementation | single arm blueberry supplementation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Blueberry Supplementation | single arm blueberry supplementation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Error | pg/mL | Baseline, 12 weeks |
|
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blueberry Supplementation | All participants will receive 18 grams lyophilized blueberry supplement mixed with water twice daily for 12 weeks. lyophilized blueberry supplement: lyophilized blueberry supplement bid |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| altered mental status | Nervous system disorders | Non-systematic Assessment | Subject admitted to hospital overnight for altered mental status and generalized weakness. Workup negative for stroke but TIA could not be ruled out. Symptoms resolved by discharge. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. P. Murali Doraiswamy | Duke University Medical Center | 9196845933 | murali.doraiswamy@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 29, 2021 | Apr 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| 24117094 | 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. |
| 19954954 | 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. |
| 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education | Mean | Standard Deviation | years |
|
| Mini-Mental State Examination (MMSE) | The MMSE (Mini Mental State Examination) is a 30 question test measuring several cognitive domains including memory, orientation, attention and language. The test is scored on a scale of 0 to 30 with higher scores indicating better cognitive function. MCI range for study inclusion was 23 or higher. | Mean | Standard Deviation | units on a scale |
|
| Weschler Logical Memory Delay | The Weschler Logical memory test involves reading a story to the subject and asking them to recall the story verbatim immediately after presentation as well as after a 20-30 minute delay. The story has 25 discrete details and recall score ranges from 0-25. The lower the score, the greater the cognitive impairment. MCI is defined by a delayed Logical memory score of <12 (if ≥16 years education) or ≤9 (if 8-15 years education). | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | 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 | Posted | Mean | Standard Error | pg/mL | Baseline, 12 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Error | ratio | Baseline, 12 weeks |
|
|
|
|
| Primary | 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 | Posted | Mean | Standard Error | pg/mL | Baseline, 12 weeks |
|
|
|
|
| Primary | Change in Blood Interleukin-6 (IL-6) Levels as Measured by Blood Biomarker Assay | Data not collected. | Posted | Baseline, 12 weeks |
|
|
| Primary | Change in Tumor Necrosis Factor (TNF-alpha) Levels as Measured by Blood Biomarker Assay | Data not collected. | Posted | Baseline, 12 weeks |
|
|
| Primary | Change in Brain-derived Neurotrophic Factor (BDNF) | Change in brain-derived neurotrophic factor (BDNF) from baseline to 12 weeks in pg/mL | Posted | Mean | Standard Error | pg/mL | Baseline, 12 weeks |
|
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 5 |
| 10 |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment | 1 episode |
|
| tremor/weakness | Nervous system disorders | Non-systematic Assessment | transient |
|
| Covid infection | Infections and infestations | Non-systematic Assessment |
|
| hematemesis | Gastrointestinal disorders | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |