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Hypo-hydration Mood and Cognition

S

Swansea University

Status

Unknown

Conditions

Cognitive Change
Mood

Treatments

Biological: Salt with / without water

Study type

Interventional

Funder types

Other

Identifiers

NCT03948230
DB-0519

Details and patient eligibility

About

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.

Full 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.

Enrollment

162 estimated patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

162 participants in 6 patient groups, including a placebo group

Sodium chloride / Water
Active Comparator group
Description:
300mg sodium chloride consumed in a capsule on two occasions with 300ml water
Treatment:
Biological: Salt with / without water
Sodium chloride / no water
Active Comparator group
Description:
300 mg sodium chloride consumed
Treatment:
Biological: Salt with / without water
Sodium chloride / colored water
Active Comparator group
Description:
300mg sodium chloride consumed in a capsule on two occasions with 300ml coloured water
Treatment:
Biological: Salt with / without water
Placebo / water
Placebo Comparator group
Description:
Placebo consumed in a capsule on two occasions with 300ml water
Treatment:
Biological: Salt with / without water
Placebo / no water
Placebo Comparator group
Description:
Placebo capsule consumed
Treatment:
Biological: Salt with / without water
Placebo / coloured water
Placebo Comparator group
Description:
Placebo consumed in a capsule on two occasions with 300ml colored water
Treatment:
Biological: Salt with / without water

Trial contacts and locations

2

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Central trial contact

Hayley A Young, PhD; David Benton, DSc

Data sourced from clinicaltrials.gov

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