Hypo-hydration Mood and Cognition

NCT ID: NCT03948230

Last Updated: 2019-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Mood Cognitive Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study has six arms. Salt alone; salt plus water; salt plus colored water; placebo alone; placebo plus water; placebo plus colored water
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

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

Study Groups

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Sodium chloride / Water

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

Group Type ACTIVE_COMPARATOR

Salt with / without water

Intervention Type BIOLOGICAL

Drinks with and without a salt containing capsule

Sodium chloride / no water

300 mg sodium chloride consumed

Group Type ACTIVE_COMPARATOR

Salt with / without water

Intervention Type BIOLOGICAL

Drinks with and without a salt containing capsule

Sodium chloride / colored water

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

Group Type ACTIVE_COMPARATOR

Salt with / without water

Intervention Type BIOLOGICAL

Drinks with and without a salt containing capsule

Placebo / water

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

Group Type PLACEBO_COMPARATOR

Salt with / without water

Intervention Type BIOLOGICAL

Drinks with and without a salt containing capsule

Placebo / no water

Placebo capsule consumed

Group Type PLACEBO_COMPARATOR

Salt with / without water

Intervention Type BIOLOGICAL

Drinks with and without a salt containing capsule

Placebo / coloured water

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

Group Type PLACEBO_COMPARATOR

Salt with / without water

Intervention Type BIOLOGICAL

Drinks with and without a salt containing capsule

Interventions

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Salt with / without water

Drinks with and without a salt containing capsule

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swansea University

OTHER

Sponsor Role lead

Responsible Party

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David Benton

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Benton, DSc

Role: PRINCIPAL_INVESTIGATOR

Professor of Psychology

Locations

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Psychology, Swansea University

Swansea, Wales, United Kingdom

Site Status RECRUITING

Swansea University

Swansea, Wales, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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David Benton, DSc

Role: CONTACT

++441792295607

Hayley A Young, PhD

Role: CONTACT

++441792295908

Facility Contacts

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Hayley Young, PhD

Role: primary

++44 1792 295607

David Benton, DSc

Role: backup

++44 1792 295607

David Benton, DSc

Role: primary

++44 1792 295607

Sara Long, B.Sc.

Role: backup

++44 1792 295278

Other Identifiers

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DB-0519

Identifier Type: -

Identifier Source: org_study_id

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