Randomised, Double-blind, Placebo Controlled, Crossover Trial Investigating the Acute Effects of Blueberry (Poly)Phenols on Vascular Function and Cognitive Performance in Healthy Individuals Across the Life Course.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Cognitive function
研究概览
简要总结
This study aims to determine the effect of blueberry (poly)phenol vs placebo on vascular function and cognitive performance with an insight into cerebral blood flow velocity changes, across all ages of the general healthy population.
详细描述
Foods rich in certain (poly)phenols, particularly flavonoids, such as berries, have been shown to improve measures of vascular function as well as cognitive performance in human intervention studies. Blueberries are rich in anthocyanins, a subclass of flavonoids that have been widely linked to health benefits, particularly improvements in endothelial function. Research have previously shown that blueberries improve executive functioning and memory in both healthy adults and children. These improvements were seen within 2-5 hours post-consumption of blueberries, a time-course that positively correlates with improvements in vascular function (measured as flow-mediated dilation). This indicates that increases in blood flow may influence improvements in cognitive performance. To date no study has investigated whether blueberry consumption can induce an increase in cerebral blood flow, with subsequent improvements in vascular and cognitive function. In this study, investigators aim to directly link wild blueberry consumption with increased vascular and cerebral blood flow and positive cognitive outcomes in healthy individuals through the life course, between the ages of 8 and 80 years old. Investigators will use a large group of healthy subjects representative of the general public over a wide age range in males and females to evaluate the generalisability of the health benefits of blueberry consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 80 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Manifest cardiovascular diseases including coronary artery disease, cerebrovascular disease and peripheral artery disease.
- •Hypertensive, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal to 90 mmHg.
- •Obese participants, defined as BMI superior or equal to
- •Diabetes mellitus and metabolic syndrome.
- •Acute inflammation, terminal renal failure or malignancies.
- •Abnormal heart rhythm (lower or higher than 60-100 bpm).
- •Allergies to berries or another significant food allergy.
- •Subjects under medication or on vitamin/dietary supplements (within 2 weeks of baseline).
- •Subjects who have lost more than 10% of their weight in the past 6 months or are currently on a diet.
- •Subjects who reported participant in another study within one month before the study starts.
- •Subjects who smoke cigarettes.
- •MCI or dyslexic or unable to complete the cognitive function tasks for any reason such as visual impairments.
- •Subjects who require chronic antimicrobial or antiviral treatment.
- •Subjects with unstable psychological condition.
- •Subjects with history of cancer, myocardial infarction, cerebrovascular incident.
- •Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
结局指标
主要结局
Cognitive function
时间窗: Change from baseline cognitive function at 2 hours post-consumption
Cognitive testing involves the participant conducting tasks administered on a tablet-style laptop. The participants will be conducting these tasks whilst cerebral blood flow measurements are taking place. The cognitive testing battery will consist of 4 tasks including a mood assessment (PANAS).
Endothelial Function
时间窗: Change from baseline endothelial function at 2 hours post-consumption
Flow mediated dilation (FMD)
次要结局
- Blood pressure(Change from baseline systolic blood pressure at 2 hours post consumption)
- Cerebral blood flow (CBF)(Change of baseline cerebral blood flow at 2 hours post consumption)
研究者
Dr Ana Rodriguez-Mateos
Principal Investigator
King's College London
