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临床试验/NCT07170943
NCT07170943撤回不适用

The Effect of Blueberry Supplementation on Cognitive Functioning in Older Adults

Wageningen University0 个研究点开始时间: 2021年11月1日最近更新:

试验速览

阶段
不适用
状态
撤回
主要终点
Verbal fluency

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Treatment is only partly masked for the participants; blueberry freeze-dried powder and placebo treatments are masked, but whole berry treatment is not.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Verbal fluency

时间窗: 12 weeks

Performance on verbal fluency

次要结局

  • Metabolic health(12 weeks)
  • Mental well-being(12 weeks)
  • Cognition(12 weeks)
  • Oxidative stress(12 weeks)
  • Cognitive functioning(12 weeks)
  • Cognitive function(12 weeks)
  • Inflammation - CRP(12 weeks)
  • Inflammation - TNFalpha(12 weeks)
  • Inflammation - IL6(12 weeks)
  • Intestinal health(12 weeks)
  • Neurotransmitters(12 weeks)
  • Vascular health(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisette de Groot

Dr.

Wageningen University

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