Aronia and Cognitive Fitness: Focus on Brain Insulin-Sensitivity and Vascular Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Brain insulin sensitivity
研究概览
简要总结
Previously, beneficial effects of Aronia Melanocarpa extract (AME) supplementation on cognitive performance has been observed in healthy middle-aged adults. However, underlying mechanisms have not yet been addressed. In addition, effects of AME are unknown in subjects at increased risk of cognitive impairment. It is hypothesized that supplementation with AME enhances (regional) brain vascular function and brain insulin-sensitivity, thereby improving cognitive function of subjects at increased risk of cognitive impairment.
The primary objectives are to investigate effects of AME intake on brain vascular function and insulin-sensitivity in cognitive-control brain areas, while we will also evaluate changes in cognitive function (secondary objective).
The present study is a randomized, double-blind, placebo-controlled, cross-over trial consisting of two study groups and a pre- and post-test day in both study arms.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 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 55-75 years
- •BMI between 25-35 kg/m2
- •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 evidenced during the screening visit
排除标准
- •Smoking or smoking cessation < 12 months
- •Presence of diabetes mellitus
- •Active cardiovascular disease like congestive heart failure or cardiovascular event
- •Severe medical conditions, including asthma, chronic obstructive pulmonary disease (COPD), kidney failure, auto-inflammatory diseases or rheumatoid arthritis
- •Unstable body weight (weight gain or loss > 3 kg in the past three months)
- •Use of dietary supplements or medication affecting the main outcomes of the study
- •Use of an investigational product within another biomedical intervention trial within the previous month
- •Contra-indications for MRI imaging (e.g., pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)
- •Left-handedness
- •Familial hypercholesterolemia
- •Abuse of drugs
- •More than 3 alcoholic consumptions per day
- •Use medication to treat blood pressure, lipid or glucose metabolism
结局指标
主要结局
Brain insulin sensitivity
时间窗: Change after 6 weeks of intervention
cerebral blood flow as quantified non-invasively by the MRI perfusion method arterial spin labeling (ASL MRI) before and after application of intranasal insulin (160 IU). Higher cerebral blood flow after intranasal insulin application indicates improved brain insulin sensitivity
Brain Vascular function
时间窗: Change after 6 weeks of intervention
cerebral blood flow as quantified non-invasively by the MRI perfusion method arterial spin labeling (ASL MRI). Higher cerebral blood flow indicates improved brain vascular function.
次要结局
- Cognitive performance(Change after 6 weeks of intervention)