Hypo-hydration Mood and Cognition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Mood, Cognitive Change

Intervention / Treatment
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* Biological: Salt with / without water


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 18 to 30 years Non-smokers BMI < 30 By self-report in good health Not taking medication for any psychological or other health disorder. Exclusion Criteria: Do not meet inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study has six arms. Salt alone; salt plus water; salt plus colored water; placebo alone; placebo plus water; placebo plus colored water
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium chloride / Water<br>300mg sodium chloride consumed in a capsule on two occasions with 300ml water | Biological: Salt with / without water<br>* Drinks with and without a salt containing capsule<br>|
| Active Comparator: Sodium chloride / no water<br>300 mg sodium chloride consumed | Biological: Salt with / without water<br>* Drinks with and without a salt containing capsule<br>|
| Active Comparator: Sodium chloride / colored water<br>300mg sodium chloride consumed in a capsule on two occasions with 300ml coloured water | Biological: Salt with / without water<br>* Drinks with and without a salt containing capsule<br>|
| Placebo Comparator: Placebo / water<br>Placebo consumed in a capsule on two occasions with 300ml water | Biological: Salt with / without water<br>* Drinks with and without a salt containing capsule<br>|
| Placebo Comparator: Placebo / no water<br>Placebo capsule consumed | Biological: Salt with / without water<br>* Drinks with and without a salt containing capsule<br>|
| Placebo Comparator: Placebo / coloured water<br>Placebo consumed in a capsule on two occasions with 300ml colored water | Biological: Salt with / without water<br>* Drinks with and without a salt containing capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood rating: agreeable / hostile | 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. | Changes from baseline after 90 and 180 minutes | 
| Mood rating: confused / clearheaded | 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. | Changes from baseline after 90 and 180 minutes | 
| Mood rating: composed / anxious | 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. | Changes from baseline after 90 and 180 minutes | 
| Mood rating: depressed / elated | 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. | Changes from baseline after 90 and 180 minutes | 
| Mood rating: tired / energetic | 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. | Changes from baseline after 90 and 180 minutes | 
| Mood rating: confident / unsure | 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. | Changes from baseline after 90 and 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodic memory | A list of 30 words will be presented after which the subject writes down as many as can be recalled. The resulting score will vary from 0-30. | Changes from baseline after 90 and 180 minutes | 
| Serial Sevens; test of working memory | 28 numbers each of three digits will be presented and the subject indicates whether a subsequent number was exactly seven less. The measure reported is the response time in milli-seconds taken to respond | Changes from baseline after 90 and 180 minutes | 
| Attention: Arrow Flankers | A series is presented that can be >>>>> or >><>> and the subject has to indicated whether the middle symbol points to the right or left. The measure reported is the time taken to respond in milli-seconds | Changes from baseline after 90 and 180 minutes | 
| Reaction times | The time to press a button under an illuminated light was recorded in milli-seconds when there was 1, 2, 4, or 8 possible lamps that could be lit. 20 trials were performed with each of the four number of lights. | Changes from baseline after 90 and 180 minutes |