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The Effect of Blueberry Supplementation on Cognitive Functioning in Older Adults (BrainBerries)

W

Wageningen University

Status

Withdrawn

Conditions

Aging
Cognitive Decline
Cognition Disorders in Old Age

Treatments

Other: Blueberry
Dietary Supplement: Placebo powder
Dietary Supplement: Freeze-dried blueberry powder

Study type

Interventional

Funder types

Other

Identifiers

NCT07170943
NL77025.091.21

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 3 patient groups, including a placebo group

Whole blueberries
Experimental group
Description:
Participants will consume a daily dose of 150g of whole blueberries
Treatment:
Other: Blueberry
Freeze-dried blueberry powder
Experimental group
Description:
Participants will consume a daily dose of 24g freeze-dried blueberry powder, equivalent to 150g whole blueberries
Treatment:
Dietary Supplement: Freeze-dried blueberry powder
Placebo powder
Placebo Comparator group
Description:
Participants will consume a daily dose of 24g colour- and flavour-matched maltodextrin powder
Treatment:
Dietary Supplement: Placebo powder

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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