临床试验/NCT03247114

NCT03247114已完成不适用

Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose

Unilever R&D1 个研究点分布在 1 个国家目标入组 16 人开始时间: 2015年2月22日最近更新: 2017年8月11日

适应症

干预措施

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: Hypothalamic function in response to glucose, fructose, sucrose, and sucralose

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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 (reference) or water to which different sweeteners 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 different sweeteners, fMRI will be performed before, during and after ingestion of 300 ml plain water or 300 ml water containing 50 g glucose, 50 g fructose, 50 g sucrose or 0.33 g sucralose (high intensity sweetener not providing energy). All beverages will be consumed at 22 °C.

The study uses a randomized 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.

Blood Oxygen Level Dependent 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: 是

入选标准

•Signed informed consent
•Age between 18 and 25 years
•BMI between 20 and 24 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

研究组 & 干预措施

Fructose-glucose-sucrose-water-sucralose

Experimental

First fructose, then glucose, then sucrose, then plain water and then sucralose

干预措施: Water (Other)

Glucose-water-fructose-sucralose-sucrose

Experimental

First glucose, then plain water, then fructose, then sucralose and then sucrose

干预措施: Glucose (Other)

Glucose-water-fructose-sucralose-sucrose

Experimental

First glucose, then plain water, then fructose, then sucralose and then sucrose

干预措施: Fructose (Other)

Sucralose-water-sucrose-glucose-fructose

Experimental

First sucralose, then plain water, then sucrose, then glucose and then fructose

干预措施: Fructose (Other)

Sucrose-fructose-sucralose-glucose-water

Experimental

First sucrose, then fructose, then sucralose, then glucose and then plain water

干预措施: Water (Other)

Glucose-fructose-water-sucrose-sucralose

Experimental

First glucose, then fructose, then plain water, then sucrose and then sucralose

干预措施: Water (Other)

Fructose-sucrose-glucose-sucralose-water

Experimental

First fructose, then sucrose, then glucose, then sucralose and then plain water

干预措施: Fructose (Other)

water-sucralose-glucose-sucrose-fructose

Experimental

First plain water, then sucralose, then glucose, then sucrose and then fructose

干预措施: Fructose (Other)

Glucose-water-fructose-sucralose-sucrose

Experimental

First glucose, then plain water, then fructose, then sucralose and then sucrose

干预措施: Sucralose (Other)

Fructose-sucrose-glucose-sucralose-water

Experimental

First fructose, then sucrose, then glucose, then sucralose and then plain water

干预措施: Sucrose (Other)

Sucralose-water-sucrose-glucose-fructose

Experimental

First sucralose, then plain water, then sucrose, then glucose and then fructose

干预措施: Glucose (Other)

Sucrose-fructose-sucralose-glucose-water

Experimental

First sucrose, then fructose, then sucralose, then glucose and then plain water

干预措施: Glucose (Other)

Glucose-fructose-water-sucrose-sucralose

Experimental

First glucose, then fructose, then plain water, then sucrose and then sucralose

干预措施: Sucralose (Other)

water-sucralose-glucose-sucrose-fructose

Experimental

First plain water, then sucralose, then glucose, then sucrose and then fructose

干预措施: Sucralose (Other)

Sucrose-sucralose-fructose-water-glucose

Experimental

First sucrose, then sucralose, then fructose, then plain water and then glucose

干预措施: Glucose (Other)

Glucose-fructose-water-sucrose-sucralose

Experimental

First glucose, then fructose, then plain water, then sucrose and then sucralose

干预措施: Glucose (Other)

Glucose-water-fructose-sucralose-sucrose

Experimental

First glucose, then plain water, then fructose, then sucralose and then sucrose

干预措施: Water (Other)

Glucose-fructose-water-sucrose-sucralose

Experimental

First glucose, then fructose, then plain water, then sucrose and then sucralose

干预措施: Sucrose (Other)

Water-glucose-sucralose-fructose-sucrose

Experimental

First plain water, then glucose, then sucralose, then fructose and then sucrose

干预措施: Glucose (Other)

water-sucralose-glucose-sucrose-fructose

Experimental

First plain water, then sucralose, then glucose, then sucrose and then fructose

干预措施: Sucrose (Other)

Sucrose-fructose-sucralose-glucose-water

Experimental

First sucrose, then fructose, then sucralose, then glucose and then plain water

干预措施: Sucrose (Other)

Sucrose-fructose-sucralose-glucose-water

Experimental

First sucrose, then fructose, then sucralose, then glucose and then plain water

干预措施: Fructose (Other)

Sucrose-sucralose-fructose-water-glucose

Experimental

First sucrose, then sucralose, then fructose, then plain water and then glucose

干预措施: Sucrose (Other)

Sucralose-sucrose-water-fructose-glucose

Experimental

First sucralose, then sucrose, then plain water, then fructose and then glucose

干预措施: Fructose (Other)

Sucralose-water-sucrose-glucose-fructose

Experimental

First sucralose, then plain water, then sucrose, then glucose and then fructose

干预措施: Sucrose (Other)

Sucralose-sucrose-water-fructose-glucose

Experimental

First sucralose, then sucrose, then plain water, then fructose and then glucose

干预措施: Glucose (Other)

Sucralose-sucrose-water-fructose-glucose

Experimental

First sucralose, then sucrose, then plain water, then fructose and then glucose

干预措施: Sucralose (Other)

Sucralose-sucrose-water-fructose-glucose

Experimental

First sucralose, then sucrose, then plain water, then fructose and then glucose

干预措施: Sucrose (Other)

Sucralose-sucrose-water-fructose-glucose

Experimental

First sucralose, then sucrose, then plain water, then fructose and then glucose

干预措施: Water (Other)

Sucralose-water-sucrose-glucose-fructose

Experimental

First sucralose, then plain water, then sucrose, then glucose and then fructose

干预措施: Sucralose (Other)

Glucose-fructose-water-sucrose-sucralose

Experimental

First glucose, then fructose, then plain water, then sucrose and then sucralose

干预措施: Fructose (Other)

Fructose-sucrose-glucose-sucralose-water

Experimental

First fructose, then sucrose, then glucose, then sucralose and then plain water

干预措施: Water (Other)

Fructose-glucose-sucrose-water-sucralose

Experimental

First fructose, then glucose, then sucrose, then plain water and then sucralose

干预措施: Glucose (Other)

Water-glucose-sucralose-fructose-sucrose

Experimental

First plain water, then glucose, then sucralose, then fructose and then sucrose

干预措施: Water (Other)

water-sucralose-glucose-sucrose-fructose

Experimental

First plain water, then sucralose, then glucose, then sucrose and then fructose

干预措施: Glucose (Other)

Glucose-water-fructose-sucralose-sucrose

Experimental

First glucose, then plain water, then fructose, then sucralose and then sucrose

干预措施: Sucrose (Other)

Sucralose-water-sucrose-glucose-fructose

Experimental

First sucralose, then plain water, then sucrose, then glucose and then fructose

干预措施: Water (Other)

Water-glucose-sucralose-fructose-sucrose

Experimental

First plain water, then glucose, then sucralose, then fructose and then sucrose

干预措施: Fructose (Other)

Sucrose-sucralose-fructose-water-glucose

Experimental

First sucrose, then sucralose, then fructose, then plain water and then glucose

干预措施: Fructose (Other)

water-sucralose-glucose-sucrose-fructose

Experimental

First plain water, then sucralose, then glucose, then sucrose and then fructose

干预措施: Water (Other)

Sucrose-sucralose-fructose-water-glucose

Experimental

First sucrose, then sucralose, then fructose, then plain water and then glucose

干预措施: Sucralose (Other)

Water-glucose-sucralose-fructose-sucrose

Experimental

First plain water, then glucose, then sucralose, then fructose and then sucrose

干预措施: Sucralose (Other)

Sucrose-sucralose-fructose-water-glucose

Experimental

First sucrose, then sucralose, then fructose, then plain water and then glucose

干预措施: Water (Other)

Fructose-sucrose-glucose-sucralose-water

Experimental

First fructose, then sucrose, then glucose, then sucralose and then plain water

干预措施: Sucralose (Other)

Fructose-sucrose-glucose-sucralose-water

Experimental

First fructose, then sucrose, then glucose, then sucralose and then plain water

干预措施: Glucose (Other)

Fructose-glucose-sucrose-water-sucralose

Experimental

First fructose, then glucose, then sucrose, then plain water and then sucralose

干预措施: Sucralose (Other)

Sucrose-fructose-sucralose-glucose-water

Experimental

First sucrose, then fructose, then sucralose, then glucose and then plain water

干预措施: Sucralose (Other)

Fructose-glucose-sucrose-water-sucralose

Experimental

First fructose, then glucose, then sucrose, then plain water and then sucralose

干预措施: Fructose (Other)

Water-glucose-sucralose-fructose-sucrose

Experimental

First plain water, then glucose, then sucralose, then fructose and then sucrose

干预措施: Sucrose (Other)

Fructose-glucose-sucrose-water-sucralose

Experimental

First fructose, then glucose, then sucrose, then plain water and then sucralose

干预措施: Sucrose (Other)

结局指标

主要结局

Hypothalamic function in response to glucose, fructose, sucrose, and sucralose

时间窗: Change from baseline (measured during 5 minutes before start of dinking) to post consumption (measured during 12 minutes after drinking). Drinking took 4 minutes.

fMRI will be performed before and after ingestion

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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