Randomised, Double-blind, Placebo Controlled, Parallel Trial Investigating the Daily Effects of Blueberry (Poly)Phenol Consumption on Vascular Function and Cognitive Performance in Healthy Elderly Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Endothelial Function
研究概览
简要总结
Foods rich in certain (poly)phenols, particularly flavonoids, such as berries and cocoa, have been shown to improve measures of vascular function as well as cognitive performance in human intervention studies. This is a randomized, double-blind, placebo controlled, parallel trial investigating the effects of daily blueberry (poly)phenol consumption on vascular function and cognitive performance in healthy elderly individuals. The study will be conducted at King's College London, Franklin-Wilkins Building.
Eligible subjects will be healthy males and females aged 65-80.
详细描述
To date no study has investigated whether daily blueberry consumption can induce an increase in cerebral blood flow, with subsequent improvements in vascular and cognitive function. In this study, the investigators aim to directly link daily blueberry consumption with improved vascular function, increased cerebral blood flow and positive cognitive outcomes in healthy elderly individuals. The investigators will use a large group of elderly individuals' representative of a healthy population, both males and females, aged 65-80 years to evaluate the health effects of daily blueberry consumption.
The main aim is to investigate whether improvements in vascular and cognitive function previously seen after blueberry consumption can be seen following 3-months daily consumption in elderly individuals, and whether enhanced cognitive performance is correlated with increased cerebral blood flow. The investigators hypothesise that daily consumption of an anthocyanin rich blueberry drink will improve cognitive performance and vascular function, increasing cerebral blood flow, in healthy older individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will include 60 healthy male and female volunteers, aged 65-
- •Volunteers will be able to understand the nature of the study and able to give signed written informed consent.
- •Subjects willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study.
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.
- •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 irregularly.
- •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
Endothelial Function
时间窗: Baseline and 12 weeks post-intervention
Changes in flow-mediated dilation of the brachial artery (FMD) from baseline after 12-week consumption of blueberry vs control
Cognitive function
时间窗: Baseline and 12 weeks post-intervention
Changes in cognitive function from baseline after 12-week consumption of blueberry vs control. 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 which are Auditory Verbal learning task, Corsi Blocks, Switching task and Serials 3's and 7's, including a mood assessment (PANAS).
次要结局
- Office systolic blood pressure(Baseline and 12 weeks post-intervention)
- Pulse wave velocity (PWV)(Baseline and 12 weeks post-intervention)
- Mood(Baseline and 12 weeks post-intervention)
- Change in Blood lipids concentration (Total, HDL and LDL cholesterol, triglycerides)(Baseline and 12 weeks post-intervention)
- 24-hour ambulatory systolic blood pressure(Baseline and 12 weeks post-intervention)
- Pulsatility index (PI)(Baseline and 12 weeks post-intervention)
- 24-hour ambulatory diastolic blood pressure(Baseline and 12 weeks post-intervention)
- Cerebral blood flow velocity (CBFv)(Baseline and 12 weeks post-intervention)
- Plasma blueberry (poly)phenol metabolites(Baseline and 12 weeks post-intervention)
- Urine blueberry polyphenol metabolites(Baseline and 12 weeks post-intervention)
- Office diastolic blood pressure(Baseline and 12 weeks post-intervention)
- Augmentation Index (AIx)(Baseline and 12 weeks post-intervention)
- Microbiome analysis(Baseline and 12 weeks post-intervention)
- Number of volunteers with treatment-related adverse events(Baseline and 12 weeks post-intervention)
研究者
Dr Ana Rodriguez-Mateos
Principal Investigator
King's College London