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临床试验/NCT03948230
NCT03948230Unknown不适用

Hypo-hydration, Mood and Cognition: the Effect of the Colour and Type of Drink

Swansea University4 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
162
试验地点
4
主要终点
Mood rating: agreeable / hostile

研究概览

简要总结

Recently changes in mood and cognition have been reported following minor reductions in hydration status. The aim is to explore that such changes in part at least reflect placebo response; therefore the consumption of plain or coloured water will be compared in drinks designed to differ in their ability to rehydrate.

详细描述

162 individuals will be subject to a temperature of 30°C for three hours, and mood and cognition monitored. Randomly on two occasions they will consume no drink or 300ml of plain or red colored water. In addition they will take a capsule containing sodium chloride or a placebo. Mood will be monitored using visual analogue scales and a battery of cognitive tests will be completed on three occasions: attention, episodic and working memory, reactions times. Urine osmolality will be measured at the beginning and end of the study and changes in body mass will be recorded. Changes in functioning will be related to the nature of the drink and changes in osmolality and body mass.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

盲法说明

Salt / placebo will be consumed by capsule under a double-blind procedure

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Do not meet inclusion criteria

研究组 & 干预措施

Sodium chloride / Water

Active Comparator

300mg sodium chloride consumed in a capsule on two occasions with 300ml water

干预措施: Salt with / without water (Biological)

Sodium chloride / no water

Active Comparator

300 mg sodium chloride consumed

干预措施: Salt with / without water (Biological)

Sodium chloride / colored water

Active Comparator

300mg sodium chloride consumed in a capsule on two occasions with 300ml coloured water

干预措施: Salt with / without water (Biological)

Placebo / water

Placebo Comparator

Placebo consumed in a capsule on two occasions with 300ml water

干预措施: Salt with / without water (Biological)

Placebo / no water

Placebo Comparator

Placebo capsule consumed

干预措施: Salt with / without water (Biological)

Placebo / coloured water

Placebo Comparator

Placebo consumed in a capsule on two occasions with 300ml colored water

干预措施: Salt with / without water (Biological)

结局指标

主要结局

Mood rating: agreeable / hostile

时间窗: Changes from baseline after 90 and 180 minutes

A hundred millimetre lines will be anchored with the words agreeable/hostile and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.

Mood rating: tired / energetic

时间窗: Changes from baseline after 90 and 180 minutes

A hundred millimetre lines will be anchored with the words tired / energetic and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.

Mood rating: confused / clearheaded

时间窗: Changes from baseline after 90 and 180 minutes

A hundred millimetre lines will be anchored with the words confused / clearheaded and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.

Mood rating: composed / anxious

时间窗: Changes from baseline after 90 and 180 minutes

A hundred millimetre lines will be anchored with the words composed / anxious and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.

Mood rating: depressed / elated

时间窗: Changes from baseline after 90 and 180 minutes

A hundred millimetre lines will be anchored with the words depressed / elated and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.

Mood rating: confident / unsure

时间窗: Changes from baseline after 90 and 180 minutes

A hundred millimetre lines will be anchored with the words confident / unsure and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.

次要结局

  • Reaction times(Changes from baseline after 90 and 180 minutes)
  • Serial Sevens; test of working memory(Changes from baseline after 90 and 180 minutes)
  • Episodic memory(Changes from baseline after 90 and 180 minutes)
  • Attention: Arrow Flankers(Changes from baseline after 90 and 180 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Benton

Professor

Swansea University

研究点 (4)

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