Effects of Daily Protein Supplementation on Brain Function in Older Adults With Overweight or Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin spray (brain insulin-sensitivity)
研究概览
简要总结
Protein-rich foods may improve brain insulin-sensitivity, which is important for cognitive and metabolic health, and may also translate into an improved food intake regulation. It is therefore pertinent to delineate the effects of plant-derived proteins, which are a more sustainable alternative to animal-derived proteins, on brain insulin-sensitivity and related functional benefits. The hypothesis is that daily plant-derived or animal-derived protein supplementation improves brain vascular function and insulin-sensitivity, thereby improving cognitive performance and appetite control in overweight or obese older men and women.
The primary objective is to investigate in overweight or obese older adults the effect of daily protein supplementation for two weeks with either a plant-derived protein or an animal-derived protein on vascular function and insulin-sensitivity in the brain, while changes in cognitive performance and appetite-related brain reward activity will also be evaluated (secondary study objectives). Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin spray (brain insulin-sensitivity) will be quantified by the 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
- Double (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 (older adults)
- •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 evidenced during the screening visit
排除标准
- •Intolerant to milk products or fava bean allergy
- •Vegetarians
- •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)
研究组 & 干预措施
Plant-based protein
干预措施: Protein supplementation with a plant-based protein isolate (Dietary Supplement)
Animal-based protein
干预措施: Protein supplementation with an animal-based protein isolate (Dietary Supplement)
Control arm
Cornstarch providing no extra protein
干预措施: Control arm - cornstarch (Other)
结局指标
主要结局
Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin spray (brain insulin-sensitivity)
时间窗: Measured after 2 weeks of supplementation with protein isolate or control
次要结局
- Cognitive performance(Measured after 2 weeks of supplementation with protein isolate or control)
- Appetite-related brain reward activity(Measured after 2 weeks of supplementation with protein isolate or control)