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临床试验/NCT03202342
NCT03202342已完成不适用

Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Taste, Temperature and Glucose Sensing

Unilever R&D1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2013年11月11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
16
试验地点
1
主要终点
Determine hypothalamic function in response to taste, temperature and glucose sensing

研究概览

简要总结

The study will consist of five occasions with one week in between. BOLD signal intensity of the hypothalamus will be measured using fMRI. Measurements will be done before and after drinking 300 ml plain water or water to which glucose and/or ethyl butyrate will be added.

详细描述

The hypothalamus is known to be important for control of feeding behaviour as well as the regulation of temperature. Functional magnetic resonance imaging (fMRI) is a non-invasive method, which detects transient haemodynamic changes in the brain, using blood oxygen level dependent (BOLD) signal differences.

In order to investigate the role of hypothalamic neural activity in response to taste, glucose and temperature, fMRI will be performed before, during and after ingestion of 300 ml plain water or water with added ethyl butyrate (pineapple flavour), added glucose or added ethyl butyrate plus glucose. All beverages will be consumed at 22 °C and the combination will also be drunk at 0 °C.

The study uses a randomised cross-over design in 16 healthy male subjects with a normal body weight. There will be an interval of at least one week between the five occasions.

BOLD signal intensity of the hypothalamus will be continuously measured for 21 minutes (5 minutes baseline, 4 minutes during drinking and 12 minutes after drinking).

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
None

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
  • 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 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

Determine hypothalamic function in response to taste, temperature and glucose sensing

时间窗: Before (5 minutes) and after (12 minutes) drinking

BOLD-signal intensity

次要结局

未报告次要终点

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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