Hypo-hydration Mood and Cognition

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

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.

Study Overview

• Status: Unknown
• Conditions: Cognitive Change; Mood
• Intervention / Treatment: Biological: Salt with / without water

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hayley A Young, PhD; Phone Number: ++441792295908; Email: h.a.young@swansea.a.cuk

Study Locations

• United Kingdom
  • Wales
    • Swansea, Wales, United Kingdom, sa2 8pp
      • Recruiting
      • Psychology, Swansea University
    • Swansea, Wales, United Kingdom, SA2 8PP
      • Recruiting
      • Swansea University
      • Contact: David Benton, DSc; Phone Number: ++44 1792 295607; Email: d.benton@swansea.ac.uk
      • Contact: Sara Long, B.Sc.; Phone Number: ++44 1792 295278; Email: 444451@swansea.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Swansea University
• Investigators: Principal Investigator: David Benton, DSc, Professor of Psychology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): July 31, 2019
• Study Completion (Anticipated): July 31, 2019

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DB-0519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No