Cognitive DeclineBrainBerriesNCT07170943
The Effect of Blueberry Supplementation on Cognitive Functioning in Older Adults
A study testing Blueberry and Freeze-dried blueberry powder in people with Cognitive Decline and Cognition Disorders in Old Age, run by Wageningen University.
Trial summary
In this randomized placebo controlled intervention study, the effect of 12 weeks of supplementation with either 150g whole blueberries, freeze-dried blueberry powder (dose equivalent to 150g berries) versus placebo on cognitive functioning will be investigated in older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Cognition Disorders in Old Age, Aging
- What is being tested?
- Blueberry and Freeze-dried blueberry powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥65y
- Overweight, body mass index ≥25 kg/m2
- Mild memory complaints, i.e. ≥22 points on the Cognitive Failure Questionnaire (CFQ) and reporting to have memory complaints and being hampered by these complaints
- No mild cognitive impairment, i.e. ≥26 points on the Montreal Cognitive Assessment (MoCA)
- Able to understand and perform the study procedures
Who cannot join
- Body Mass Index (BMI) ≥35 kg/m2
- Current use of >500 mg/day of acetylsalicylic acid
- Current use of antidepressants
- Current use of medication that affects inflammation (anti-inflammatory medication)
- Current or recent (<1 month) use of berry supplements
- Current or recent (<1 month) use of anti-inflammatory dietary supplements such as fish oil, quercetin, curcumin, resveratrol, and/or other flavonoids
Show all 13Show fewer
- Current or recent (<3 month) use of antibiotics.
- Berry consumption of more than 1 serving (150g) per week
- Not willing to quit anthocyanin-rich product consumption during the study period
- Allergy to berries/salicylates
- Having a current disease which interferes with the effect of berries/ freeze-dried berry powder and/or with the outcome measure (cognitive functioning), including diagnosis of dementia, psychiatric disorders, gastro-intestinal disease, diabetes, and cancer, as judged by a medical doctor
- Excessive alcohol consumption (on average >21 glasses/week for men and >14 glasses/week for women)
- Current participation in other scientific research
About this study
In this randomized placebo controlled intervention study, the effect of 12 weeks of supplementation with either 150g whole blueberries, freeze-dried blueberry powder (dose equivalent to 150g berries) versus placebo on cognitive functioning will be investigated in older adults.
Read the detailed description
Dementia is a public health priority. The prevalence of dementia is rapidly increasing due to population ageing, posing a great social and economic impact on caregivers, families and society. This, in combination with the lack of effective treatment options, demonstrates the urgent need for better understanding on how to prevent and slow down progression of this condition. As ageing and dementia are associated with increased levels of inflammation, nutritional compounds that exhibit anti-inflammatory properties may propose a solution. Blueberries, a good source of anthocyanins, have shown anti-inflammatory properties in several human trials. Therefore, in this randomized placebo controlled intervention study, we aim to investigate the effect of 12 weeks of supplementation with either 150g whole blueberries or freeze-dried blueberry powder (dose equivalent to 150g berries) versus placebo on cognitive functioning in overweight older adults with mild memory complaints. Secondary objectives include the assessment of whole blueberry and freeze-dried blueberry powder supplementation on inflammatory markers, oxidative stress, intestinal health markers, vascular and metabolic health markers, mental well-being, and levels of neurotransmitters.
- Conditions
- Cognitive Decline, Cognition Disorders in Old Age, Aging
- Being tested
- Blueberry, Freeze-dried blueberry powder, Placebo powder
- Keywords
- Cognition, Blueberry, Anthocyanins, Ageing
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlueberryOther
Daily consumption of blueberries
Freeze-dried blueberry powderDietary supplement
Daily consumption of a freeze-dried blueberry powder
Placebo powderDietary supplement
Daily consumption of a placebo powder
| Study group | Role | What they receive |
|---|---|---|
| Whole blueberries | Experimental | Participants will consume a daily dose of 150g of whole blueberries Receives: Other: Blueberry |
| Freeze-dried blueberry powder | Experimental | Participants will consume a daily dose of 24g freeze-dried blueberry powder, equivalent to 150g whole blueberries Receives: Dietary Supplement: Freeze-dried blueberry powder |
| Placebo powder | Placebo comparator | Participants will consume a daily dose of 24g colour- and flavour-matched maltodextrin powder Receives: Dietary Supplement: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal fluency
Performance on verbal fluency
Measured: 12 weeks
Secondary outcomes (20)
Cognitive functioning
Rey Auditory Verbal Learning Test (RAVLT)
Measured: 12 weeks
Cognitive function
Wechsler Digit Span Task (forward, backward, sequencing) WAIS-IV
Measured: 12 weeks
Cognition
Symbol digit modalities test
Measured: 12 weeks
Cognition
Trail Making Test (TMT) version A and B
Measured: 12 weeks
Cognition
Stroop Color-Word test
Measured: 12 weeks
Inflammation - CRP
Inflammatory blood marker: C-reactive protein
Measured: 12 weeks
Inflammation - TNFalpha
tumor necrosis factor-alpha
Measured: 12 weeks
Inflammation - IL6
interleukin-6
Measured: 12 weeks
Oxidative stress
total plasma nitric oxide (NO)
Measured: 12 weeks
Oxidative stress
serum superoxide dismutase (SOD)
Measured: 12 weeks
Intestinal health
Intestinal health markers as measured in blood and feces (microbiota composition, inflammatory fecal markers, microbiota-derived bioactive compounds, intestinal integrity markers
Measured: 12 weeks
Metabolic health
Blood markers of metabolic health: plasma fasting glucose,
Measured: 12 weeks
Metabolic health
Blood markers of metabolic health (plasma fasting glucose, Hb1Ac, triglyceride, adiponectin)
Measured: 12 weeks
Metabolic health
Blood markers of metabolic health: Hb1Ac,
Measured: 12 weeks
Metabolic health
Blood markers of metabolic health: triglyceride
Measured: 12 weeks
Metabolic health
Blood markers of metabolic health: adiponectin
Measured: 12 weeks
Mental well-being
Score on 12-item short form health survey
Measured: 12 weeks
Mental well-being
profiles of mood states-short form (POMS)
Measured: 12 weeks
Neurotransmitters
Levels of plasma neurotransmitters (dopamine, serotonin, (nor)adrenaline, and their metabolites)
Measured: 12 weeks
Vascular health
Markers of vascular health (systolic blood pressure, diastolic blood pressure)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study startNov 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: too time-lengthy administrative process nationally - study no longer fits in PhD trajectory window
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisette de Groot, Wageningen University
- Investigators
- Lisette de Groot, prof, Principal investigator, Division of Human Nutrition and Health, Wageningen University and Research, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170943
- Sponsor's protocol ID
- NL77025.091.21
- Acronym
- BrainBerries
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Starting 12 months after article publication. Sharing only upon reasonable request in consultation with the study team.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blueberry Supplementation on Cognitive Functioning in Older Adults
- ClinicalTrials.gov ID
- NCT07170943
- Acronym / sponsor ID
- BrainBerries / NL77025.091.21
- Conditions
- Cognitive Decline, Cognition Disorders in Old Age, Aging
- Keywords
- Cognition, Blueberry, Anthocyanins, Ageing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: too time-lengthy administrative process nationally - study no longer fits in PhD trajectory window
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized placebo controlled intervention study, the effect of 12 weeks of supplementation with either 150g whole blueberries, freeze-dried blueberry powder (dose equivalent to 150g berries) versus placebo on cognitive functioning will be investigated in older adults.
Detailed description
Dementia is a public health priority. The prevalence of dementia is rapidly increasing due to population ageing, posing a great social and economic impact on caregivers, families and society. This, in combination with the lack of effective treatment options, demonstrates the urgent need for better understanding on how to prevent and slow down progression of this condition. As ageing and dementia are associated with increased levels of inflammation, nutritional compounds that exhibit anti-inflammatory properties may propose a solution. Blueberries, a good source of anthocyanins, have shown anti-inflammatory properties in several human trials. Therefore, in this randomized placebo controlled intervention study, we aim to investigate the effect of 12 weeks of supplementation with either 150g whole blueberries or freeze-dried blueberry powder (dose equivalent to 150g berries) versus placebo on cognitive functioning in overweight older adults with mild memory complaints. Secondary objectives include the assessment of whole blueberry and freeze-dried blueberry powder supplementation on inflammatory markers, oxidative stress, intestinal health markers, vascular and metabolic health markers, mental well-being, and levels of neurotransmitters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole blueberries | Experimental | Other: BlueberryParticipants will consume a daily dose of 150g of whole blueberries |
| Freeze-dried blueberry powder | Experimental | Dietary Supplement: Freeze-dried blueberry powderParticipants will consume a daily dose of 24g freeze-dried blueberry powder, equivalent to 150g whole blueberries |
| Placebo powder | Placebo comparator | Dietary Supplement: Placebo powderParticipants will consume a daily dose of 24g colour- and flavour-matched maltodextrin powder |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥65y
- Overweight, body mass index ≥25 kg/m2
- Mild memory complaints, i.e. ≥22 points on the Cognitive Failure Questionnaire (CFQ) and reporting to have memory complaints and being hampered by these complaints
- No mild cognitive impairment, i.e. ≥26 points on the Montreal Cognitive Assessment (MoCA)
- Able to understand and perform the study procedures
Key exclusion criteria (13 listed)
- Body Mass Index (BMI) ≥35 kg/m2
- Current use of >500 mg/day of acetylsalicylic acid
- Current use of antidepressants
- Current use of medication that affects inflammation (anti-inflammatory medication)
- Current or recent (<1 month) use of berry supplements
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 |
|---|---|---|
| BlueberryDaily consumption of blueberries | Other | Whole blueberries |
| Freeze-dried blueberry powderDaily consumption of a freeze-dried blueberry powder | Dietary supplement | Freeze-dried blueberry powder |
| Placebo powderDaily consumption of a placebo powder | Dietary supplement | Placebo powder |
Primary outcome
Verbal fluency
Time frame: 12 weeks
Performance on verbal fluency
20 secondary outcomes
Cognitive functioning
Time frame: 12 weeks
Cognitive function
Time frame: 12 weeks
Cognition
Time frame: 12 weeks
Cognition
Time frame: 12 weeks
Cognition
Time frame: 12 weeks
Inflammation - CRP
Time frame: 12 weeks
Inflammation - TNFalpha
Time frame: 12 weeks
Inflammation - IL6
Time frame: 12 weeks
Oxidative stress
Time frame: 12 weeks
Oxidative stress
Time frame: 12 weeks
Intestinal health
Time frame: 12 weeks
Metabolic health
Time frame: 12 weeks
Metabolic health
Time frame: 12 weeks
Metabolic health
Time frame: 12 weeks
Metabolic health
Time frame: 12 weeks
Metabolic health
Time frame: 12 weeks
Mental well-being
Time frame: 12 weeks
Mental well-being
Time frame: 12 weeks
Neurotransmitters
Time frame: 12 weeks
Vascular health
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: Yes. Starting 12 months after article publication. Sharing only upon reasonable request in consultation with the study team.
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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.
Lisette de Groot, prof principal investigator
Division of Human Nutrition and Health, Wageningen University and Research, The Netherlands
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry and Freeze-dried blueberry powder in people with Cognitive Decline and Cognition Disorders in Old Age, run by Wageningen University.
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 5 inclusion and 13 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: withdrawn, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Verbal fluency (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2025.