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临床试验/NCT02745730
NCT02745730已完成不适用

Resting State Functional Magnetic Resonance Imaging of Human Brain Responses to Nutrient Shake

Unilever R&D1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Change from baseline in the connectivity in the default mode and salience network: glucose and fructose vs. sucralose and allulose.

研究概览

简要总结

Resting state functional magnetic resonance imaging (rsfMRl) of the brain is used to measure pleasantness after consumption of four different milkshakes with added sugars or sweeteners.

详细描述

The central role of the brain in regulating food intake and steering feeding behaviour is increasingly recognized. It is currently well accepted that the brain is the target organ to measure the effects of pleasantness and energy homeostasis in order to change feeding behaviour to reduce the rising prevalence of obesity. The effects of food on the brain are multiple and complex. In addition to primary aspects of food such as taste, texture, looks and smell, secondary aspects such as energy regulation are as much important in the entire "eating experience". Resting state functional connectivity in the brain can be assessed by the analysis of low-frequency fluctuations present in the blood-oxygenation-level-dependent (BOLD) signal in functional magnetic resonance imaging (fMRI). Investigators will use resting state functional magnetic resonance imaging (rsfMRl) to detect changes in connectivity in the default mode and salience network after consumption of four different milkshakes with added sugars or sweeteners.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Signed informed consent
  • Age between 18 and 25 years
  • BMI between 20 and 23 kg/m2
  • Weight above 70 kg
  • Length between 170 and 190 centimetres

排除标准

  • Diabetes or history of other disturbances of glucose metabolism (eg impaired glucose tolerance, hypoglycaemia).
  • Any genetic or psychiatric disease (e.g. fragile X syndrome, major depression) affecting brain
  • Any know food allergy or intolerance
  • Any significant chronic disease
  • Renal or hepatic disease
  • Recent weight changes or attempts to lose weight (> 3 kg weight gain or loss, within the last 3 months)
  • Smoking (current or last 6 months)
  • Alcohol consumption of more than 21 units per week or use of recreational drugs at present or in the last year
  • Recent blood donation (within the last 2 months)
  • Recent participation in other biomedical research projects (within the last 3 months), participation in 3 or more biomedical research projects in one year
  • Contra-indication to MRI scanning:
  • Claustrophobia
  • Pacemakers and defibrillators
  • Nerve stimulators
  • Intracranial clips
  • intraorbital or intraocular metallic fragments
  • Cochlear implants
  • Ferromagnetic implants

结局指标

主要结局

Change from baseline in the connectivity in the default mode and salience network: glucose and fructose vs. sucralose and allulose.

时间窗: Six minutes before (baseline) and 12 minutes after (response) test product intake

次要结局

  • 3. Change from baseline in the connectivity in the default mode and salience network: allulose vs. sucralose.(Six minutes before (baseline) and 12 minutes after (response) test product intake)
  • 2. Change from baseline in the connectivity in the default mode and salience network: glucose vs. fructose.(Six minutes before (baseline) and 12 minutes after (response) test product intake)

研究者

发起方
Unilever R&D
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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