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临床试验/NCT03467568
NCT03467568Unknown不适用

Do Humans Over-consume Salt to Improve Mood

Swansea University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017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
120
试验地点
2
主要终点
Mood ratings using visual analogue scales

研究概览

简要总结

Humans display a preference for salt although the reasons remain unclear. The aim was to examine the hypothesis that salt may enhance mood. The study compares the drinking of water with and without electrolytes (either dissolved in water or by capsule). Mood was rated over a period of 155 minutes

详细描述

Study 1. 120 young adults will be were recruited. They will arrive in the laboratory at 0900 having consumed their normal breakfast. Over the morning they will reported their mood by responding to one hundred millimetre visual analogue scales anchored with the words: Composed/Anxious; Hostile/Agreeable; Elated/Depressed; Unsure/Confident; Energetic/Tired; Confused/Clearheaded. These dimensions of mood came from the factor analysis that formed the basis of the Profile of Mood State questionnaire. An overall measure of mood will be calculated. .

Randomly they will receive either a 150ml glass of water, or an equivalent volume of water containing electrolytes (in total 150mg sodium chloride and 45mg potassium chloride (Gatorade G2 Low calorie (34 kcal) Thirst Quencher, Pepsico). This drink will be consumed for a first time after 50 minutes, and a second time after 140 minutes. A estimate of habitual salt preference will be gained by responding to questions concerning the adding of salt to meals and a preference for salty foods.

Study 2: One hundred and twenty young adults will be recruited. A second study attempts to replicate the first in a double-blind trial where the taste of salt was hidden by using a capsule. . Participants will be assigned to one of four experimental conditions; 1) swallowed placebo capsules; 2) swallowed capsules containing electrolyte (300mg sodium chloride); 3) received placebo capsules and plain water; 4) received capsules containing electrolyte and plain water. Each drink will be 150ml of water. The allocation of the type of capsule will be carried out double-blind, determined by computer generated random numbers.

Otherwise the procedure will be identical to study one.

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

性别
All
接受健康志愿者

入选标准

  • Self declared in good health -

排除标准

  • 未提供

研究组 & 干预措施

Sodium chloride / no water

Active Comparator

A capsule containing 300mg of sodium chloride will be consumed but no water will be drunk over the morning

干预措施: No water consumed (Biological)

Sodium chloride / Water

Active Comparator

The sodium chloride / water arm involves 300mg sodium chloride being consumed in a capsule and on two occasions 150ml of water being drunk

干预措施: Sodium Chloride (Dietary Supplement)

Sodium chloride / Water

Active Comparator

The sodium chloride / water arm involves 300mg sodium chloride being consumed in a capsule and on two occasions 150ml of water being drunk

干预措施: Water (Dietary Supplement)

Placebo / no water

Placebo Comparator

A capsule containing a placebo will be consumed but no water will be drunk over the morning

干预措施: Placebo capsule (Other)

Placebo / water

Active Comparator

A capsule containing a placebo will be consumed and on two occasions 150ml of water will be drunk

干预措施: Placebo capsule (Other)

Placebo / no water

Placebo Comparator

A capsule containing a placebo will be consumed but no water will be drunk over the morning

干预措施: No water consumed (Biological)

Sodium chloride / no water

Active Comparator

A capsule containing 300mg of sodium chloride will be consumed but no water will be drunk over the morning

干预措施: Sodium Chloride (Dietary Supplement)

Placebo / water

Active Comparator

A capsule containing a placebo will be consumed and on two occasions 150ml of water will be drunk

干预措施: Water (Dietary Supplement)

结局指标

主要结局

Mood ratings using visual analogue scales

时间窗: Up to three hours

On a hundred millimetre scale ratings will be made of with the two ends anchored with the words Agreeable/Hostile, Confused/clearheaded; composed/anxious; depressed/elated; confident/unsure; tired/energetic. Each scales produces a score between 0 and 100. When added to create a total mood score the ratings vary between zero and six hundred with a higher score indicating a better mood

次要结局

  • Ratings of thirst(Up to three hours)
  • Body weight(Up to three hours)

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 (2)

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