Clinical trial NCT03948230: Hypo-hydration Mood and Cognition
Official title: Hypo-hydration, Mood and Cognition: the Effect of the Colour and Type of Drink
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mood
Cognitive Change
Lead sponsor: Swansea University
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mood rating: agreeable / hostile
timeFrame: Changes from baseline after 90 and 180 minutes
measure: Mood rating: confused / clearheaded
timeFrame: Changes from baseline after 90 and 180 minutes
measure: Mood rating: composed / anxious
timeFrame: Changes from baseline after 90 and 180 minutes
measure: Mood rating: depressed / elated
timeFrame: Changes from baseline after 90 and 180 minutes
measure: Mood rating: tired / energetic
timeFrame: Changes from baseline after 90 and 180 minutes
measure: Mood rating: confident / unsure
timeFrame: Changes from baseline after 90 and 180 minutes
Secondary outcomes:
measure: Episodic memory
timeFrame: Changes from baseline after 90 and 180 minutes
measure: Serial Sevens; test of working memory
timeFrame: Changes from baseline after 90 and 180 minutes
measure: Attention: Arrow Flankers
timeFrame: Changes from baseline after 90 and 180 minutes
measure: Reaction times
timeFrame: Changes from baseline after 90 and 180 minutes
Other outcomes:
Locations:
city: Swansea
country: United Kingdom
facility: Psychology, Swansea University
state: Wales
city: Swansea
country: United Kingdom
facility: Swansea University
state: Wales
Study officials:
affiliation: Professor of Psychology
name: David Benton, DSc
role: PRINCIPAL_INVESTIGATOR
References: