NCT07170943

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
3 years until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

August 26, 2021

Last Update Submit

September 5, 2025

Conditions

Keywords

CognitionBlueberryAnthocyaninsAgeing

Outcome Measures

Primary Outcomes (1)

  • Verbal fluency

    Performance on verbal fluency

    12 weeks

Secondary Outcomes (20)

  • Cognitive functioning

    12 weeks

  • Cognitive function

    12 weeks

  • Cognition

    12 weeks

  • Cognition

    12 weeks

  • Cognition

    12 weeks

  • +15 more secondary outcomes

Study Arms (3)

Whole blueberries

EXPERIMENTAL

Participants will consume a daily dose of 150g of whole blueberries

Other: Blueberry

Freeze-dried blueberry powder

EXPERIMENTAL

Participants will consume a daily dose of 24g freeze-dried blueberry powder, equivalent to 150g whole blueberries

Dietary Supplement: Freeze-dried blueberry powder

Placebo powder

PLACEBO COMPARATOR

Participants will consume a daily dose of 24g colour- and flavour-matched maltodextrin powder

Dietary Supplement: Placebo powder

Interventions

Daily consumption of blueberries

Whole blueberries

Daily consumption of a freeze-dried blueberry powder

Freeze-dried blueberry powder
Placebo powderDIETARY_SUPPLEMENT

Daily consumption of a placebo powder

Placebo powder

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

blueberry extract

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Lisette de Groot, prof

    Division of Human Nutrition and Health, Wageningen University and Research, The Netherlands

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Treatment is only partly masked for the participants; blueberry freeze-dried powder and placebo treatments are masked, but whole berry treatment is not.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 26, 2021

First Posted

September 12, 2025

Study Start

November 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Starting 12 months after article publication. Sharing only upon reasonable request in consultation with the study team.

Time Frame
Starting 12 months after article publication.
Access Criteria
Upon reasonable request. Sharing will be done in consultation with the study team