The Effect of Blueberry Supplementation on Cognitive Functioning in Older Adults

NCT ID: NCT07170943

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2022-10-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Whole blueberries

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

Group Type: EXPERIMENTAL

Blueberry

Intervention Type: OTHER

Daily consumption of blueberries

Freeze-dried blueberry powder

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

Group Type: EXPERIMENTAL

Freeze-dried blueberry powder

Intervention Type: DIETARY_SUPPLEMENT

Daily consumption of a freeze-dried blueberry powder

Placebo powder

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

Group Type: PLACEBO_COMPARATOR

Placebo powder

Intervention Type: DIETARY_SUPPLEMENT

Daily consumption of a placebo powder

Interventions

Blueberry

Daily consumption of blueberries

Intervention Type: OTHER

Freeze-dried blueberry powder

Daily consumption of a freeze-dried blueberry powder

Intervention Type: DIETARY_SUPPLEMENT

Placebo powder

Daily consumption of a placebo powder

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wageningen University

OTHER

Sponsor Role: lead

Responsible Party

Lisette de Groot

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisette de Groot, prof

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

NL77025.091.21

Identifier Type: -

Identifier Source: org_study_id