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Clinical Trials/NCT03948230
NCT03948230UnknownNot Applicable

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

Swansea University2 sites in 1 country162 target enrollmentStarted: January 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
162
Locations
2
Primary Endpoint
Mood rating: agreeable / hostile

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Masking Description

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

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Sodium chloride / Water

Active Comparator

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

Intervention: Salt with / without water (Biological)

Sodium chloride / no water

Active Comparator

300 mg sodium chloride consumed

Intervention: 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

Intervention: Salt with / without water (Biological)

Placebo / water

Placebo Comparator

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

Intervention: Salt with / without water (Biological)

Placebo / no water

Placebo Comparator

Placebo capsule consumed

Intervention: Salt with / without water (Biological)

Placebo / coloured water

Placebo Comparator

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

Intervention: Salt with / without water (Biological)

Outcomes

Primary Outcomes

Mood rating: agreeable / hostile

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David Benton

Professor

Swansea University

Study Sites (2)

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