Acute Effects of Ketone Monoester Supplementation on Brain Function in Older Men with Overweight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Brain Insulin Sensitivity
研究概览
简要总结
Disturbances in brain insulin-sensitivity are not only observed in obesity and type 2 diabetes (T2D), but also during brain aging and in dementia. Ketone monoester supplements may improve brain insulin-sensitivity, which can be quantified by measuring the gray-matter cerebral blood flow (CBF) response to intranasally administered insulin. We hypothesize that acute ketone monoester supplementation increases (regional) brain vascular function and insulin-sensitivity thereby improving cognitive performance and appetite control. The primary objective is to evaluate in older men the acute effect of ketone monoester supplementation on (regional) brain vascular function and insulin-sensitivity, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labelling (ASL). The CBF response to intranasal insulin is a robust and sensitive physiological marker of brain insulin-sensitivity. Secondary objectives are to investigate effects on cognitive performance as assessed with a neuropsychological test battery, and appetite control as quantified by functional MRI (fMRI) with visual food cues.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Men, aged between 60-75 years
- •BMI between 25-30 kg/m2
- •Fasting plasma glucose < 7.0 mmol/L
- •Fasting serum TC < 8.0 mmol/L
- •Fasting serum TAG < 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
- •Left-handedness
- •Following a low-carbohydrate diet or consuming nutritional ketone supplements
- •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, or neurological or mental disorders.
- •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
Brain Insulin Sensitivity
时间窗: Change from placebo intervention at 60 minutes after supplement intake
Cerebral blood flow measurements before and after a nasal insulin spray as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Brain Vascular Function
时间窗: Change from placebo intervention at 30 minutes after supplement intake
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
次要结局
- Blood pressure(Change from placebo intervention at 90 minutes after supplement intake)
- Ketone metabolism(During 120 minutes following supplement intake)
- Glucose metabolism(During 120 minutes following supplement intake)
- Anthropometric measurements(Before supplement intake)
- Appetite-related brain reward activity(Change from placebo intervention at 40 minutes after supplement intake)
- Brain Perfusion(Change from placebo intervention at 120 minutes after supplement intake)
- Appetite hormones(During 120 minutes following supplement intake)
- Food intake(Once 120 minutes following supplement intake)
- Cognitive Performance(Change from placebo intervention at 120 minutes after supplement intake)
- Markers related to low-grade systemic inflammation(During 120 minutes following supplement intake)
- Perceived hunger and satiety(During 120 minutes following supplement intake)