Mild Cognitive ImpairmentNCT05172128
Effect of Blueberry Supplementation on Alzheimer's Biomarkers
A study testing lyophilized blueberry supplement in people with Mild Cognitive Impairment and Alzheimer Disease, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- lyophilized blueberry supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2022to 6 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Significant gastrointestinal disorders or surgery that influences digestion and absorption
- Presence of unstable, acutely symptomatic, or life-limiting illness
- Women of childbearing potential
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- lyophilized blueberry supplement
- Keywords
- MCI, biomarkers, memory loss
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lyophilized blueberry supplementDietary supplement
lyophilized blueberry supplement bid
| Study group | Role | What they receive |
|---|---|---|
| Blueberry supplementation | Experimental | All participants will receive 18 grams lyophilized blueberry supplement mixed with water twice daily for 12 weeks. Receives: Dietary Supplement: lyophilized blueberry supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline, 12 weeks
Change in Blood Interleukin-6 (IL-6) Levels as Measured by Blood Biomarker Assay
Measured: Baseline, 12 weeks
Change in Tumor Necrosis Factor (TNF-alpha) Levels as Measured by Blood Biomarker Assay
Measured: 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
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start21 Feb 2022
- Primary completion6 Feb 2023
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Responsible party
- Sponsor
- Investigators
- Murali Doraiswamy, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172128
- Sponsor's protocol ID
- Pro00108907
- Status last verified
- Sep 2024
- First submitted
- 9 Dec 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28283823Wang 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.
PubMed 26606074Jeong 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.
PubMed 24117094Brewer 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.
PubMed 19954954Ou 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blueberry Supplementation on Alzheimer's Biomarkers
- ClinicalTrials.gov ID
- NCT05172128
- Acronym / sponsor ID
- Pro00108907
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Keywords
- MCI, biomarkers, memory loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blueberry supplementation | Experimental | Dietary Supplement: lyophilized blueberry supplementAll participants will receive 18 grams lyophilized blueberry supplement mixed with water twice daily for 12 weeks. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lyophilized blueberry supplementlyophilized blueberry supplement bid | Dietary supplement | Blueberry supplementation |
Primary outcome
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
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
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.
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
Change in Blood Interleukin-6 (IL-6) Levels as Measured by Blood Biomarker Assay
Time frame: Baseline, 12 weeks
Change in Tumor Necrosis Factor (TNF-alpha) Levels as Measured by Blood Biomarker Assay
Time frame: Baseline, 12 weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28283823Miller 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.
- Background: PubMed 26606074Wang 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.
- Background: PubMed 24117094Jeong 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.
- Background: PubMed 19954954Brewer 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.
- BackgroundOu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murali Doraiswamy, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lyophilized blueberry supplement in people with Mild Cognitive Impairment and Alzheimer Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Neurofilament Light (NfL) Levels as Measured by Blood Biomarker Assay (time frame: Baseline, 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05172128, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.