Interactions Between Metabolic, Cognitive and Reward Processes in Appetite - Effects of Intranasal Administration of Insulin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- fMRI brain response during inhibition to a food stimuli
研究概览
简要总结
This study investigates the effect of intranasal insulin on cognitive processes (behavioural and neural) in healthy lean and obese female adults. All subjects will receive a single-dose of intranasal insulin and/or placebo (on different days) before participating in several cognitive tasks.
详细描述
It is well established that eating behaviour is affected by metabolic signals (e.g. insulin, ghrelin, serotonin) and is also modulated via food reward processes. However, in humans, eating behaviour is a complex process, which involves habits, long-term goals and social interaction. Thus, recently it has been proposed that higher cognitive processes such as inhibitory control, attention and memory also modulate eating.
Insulin seems to be involved in both metabolic processes and cognitive processes. In the last decade it has been shown that intranasal administration of insulin decreases food intake, especially in women, and enhances thermogenesis and memory. In addition intranasal insulin administration has been shown to affect brain areas related to homeostatic control, reward and memory.
In the proposed study the investigators will examine the effect of intranasal insulin administration on eating, and on metabolic, reward and cognitive processes and their potential interplay. The investigators will also study the effect of body weight on the actions of insulin on these processes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects
- •Age 18-65 years at start of the study
- •Body Mass Index (BMI) between 18 and 25 kg/m2 for the lean group and between 30 and 40 kg/m2 for the obese group
- •Right-handedness (including left-handers could bias the results because of the laterality of brain functions)
- •Ability to give informed consent
- •Fluent English speaking
- •Willingness to be informed about chance findings of pathology
排除标准
- •Subjects who have a non-removable metal object in or at their body, such as, for example: Heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
- •Tattoos, that are older than 15 years
- •Claustrophobia
- •Limited temperature perception and/or increased sensitivity to warming of the body
- •Pathological hearing ability or an increased sensitivity to loud noises
- •Lack of ability to give informed consent
- •Operation less than three months ago
- •Simultaneous participation in other studies that involve drugs intake or blood spending
- •Acute illness or infection during the last 4 weeks
- •Cardiovascular disorders (e.g., hypertrophic cardiomyopathy, long QT syndrome)
- •Moderate or severe head injury
- •Eating disorders
- •No metabolic (e.g. metabolic disorder, diabetes, insulin resistance), psychological (e.g. depression) or neurological (e.g. epilepsy, headache disorder, multiple sclerosis, traumatic brain injuries) diseases or medication in relation to these diseases.
- •Intake of any medication that can interfere with the drug or measurements.
- •Current weight loss regimens, or more then 5kg weight loss in the last 3 months
- •Current pregnancy or breastfeeding
- •Current or past history of drug or alcohol dependency - alcohol consumption exceeding 12 units a week
- •Food allergies (e.g. peanut allergy lactose and gluten intolerance) or vegetarian/vegan diet
- •Disliking the study lunch
研究组 & 干预措施
Insulin
In this arm a single-dose of (160 IU/1.6ml) intranasal insulin will be administrated
干预措施: Intranasal Insulin (Drug)
Placebo
In this arm a single-dose intranasal placebo will be administrated
干预措施: Intranasal Placebo (Drug)
结局指标
主要结局
fMRI brain response during inhibition to a food stimuli
时间窗: 14 minutes
Neural activation during correct inhibition food vs. non-food stimuli trail. Comparing the brain response when subjects correctly withhold for food vs a sports item.
次要结局
- Delay discount of food reward(5 minutes)
- Delay discount of money reward(5 minutes)
- fMRI brain activity in food picture task(18 minutes)
- Recall pictures(5 minutes)
- Recall words(10 minutes)
- Emotional categorisation(10 minutes)
- Emotional recall part 1(10 minutes)
- Cookie intake(10 minutes)
- fMRI neural network during inhibition to a food stimuli(14 minutes)
- fMRI brain responses during inhibition(14 minutes)