Longer-term Effects of Wild Blueberry Consumption on Brain Function in Older Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- MRI-brain perfusion measurement Arterial Spin Labeling
研究概览
简要总结
Impaired brain vascular function precedes the development of reduced cognitive performance, while brain insulin-resistance is associated with cognitive decline. Evidence from epidemiological studies has already suggested beneficial effects of wild blueberry consumption on cognitive performance. However, underlying mechanisms have not yet been established, while well-controlled trials on longer-term effects of wild blueberries on cognitive performance are highly needed. This study hypothesizes that longer-term wild blueberry intake improves (regional) brain vascular function and insulin-sensitivity, thereby improving cognitive performance in older men and women. The primary objectives are to investigate in older adults the effect wild blueberry consumption on (regional) vascular function and insulin-sensitivity in the brain, and to focus on changes in cognitive performance as assessed with the CANTAB neuropsychological test battery (i.e., secondary objective). Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin spray (brain insulin-sensitivity) will be non-invasively quantified by the non-invasive gold standard magnetic resonance imaging (MRI)- perfusion method Arterial Spin Labeling (ASL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women, aged between 60-75 years
- •BMI between 25-35 kg/m2 (overweight or obese)
- •Fasting plasma glucose < 7.0 mmol/L
- •Fasting serum total cholesterol < 8.0 mmol/L
- •Fasting serum triacylglycerol < 4.5 mmol/L
- •Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
- •Stable body weight (weight gain or loss < 3 kg in the past three months)
- •Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study.
- •No difficult venipuncture as evidences during the screening visit.
排除标准
- •Allergy or intolerance to berries
- •Left-handedness
- •Current smoker, or smoking cessation < 12 months
- •Diabetic patients
- •Familial hypercholesterolemia
- •Abuse of drugs
- •More than 3 alcoholic consumptions per day
- •Use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators
- •Use medication to treat blood pressure, lipid, or glucose metabolism
- •Use of an investigational product within another biomedical intervention trial within the previous 1-month
- •Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases, and rheumatoid arthritis.
- •Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident.
- •Contra-indications for MRI imaging (e.g., pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)
结局指标
主要结局
MRI-brain perfusion measurement Arterial Spin Labeling
时间窗: Change in brain perfusion at the end of a 16-week wild blueberry intervention and a 16-week control period with a matched placebo.
Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin (brain insulin-sensitivity) will be non-invasively quantified by MRI-perfusion method Arterial Spin Labeling (ASL).
次要结局
- Cognitive performance measurement by Cambridge Neuropsychological Test Automated Battery(Change in cognitive performance at the end of a 16-week wild blueberry intervention and a 16-week control period with a matched placebo.)
- Brain Insulin Sensitivity(Change in outcomes at the end of a 16-week wild blueberry intervention and 16-week control period with a matched placebo.)