Hypo-hydration Mood and Cognition

Cognitive Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03948230
• Other study ID #: DB-0519
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: May 2019
• Source: Swansea University
• Contact: David Benton, DSc
• Phone: ++441792295607
• Email: d.benton[@]swansea.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change
• Mood

Intervention

Biological:
• Salt with / without water
Drinks with and without a salt containing capsule

Locations

Country	Name	City	State
United Kingdom	Psychology, Swansea University	Swansea	Wales
United Kingdom	Swansea University	Swansea	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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