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Hypo-hydration Mood and Cognition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948230
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
David Benton, Swansea University

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.

Condition or disease Intervention/treatment Phase
Mood Cognitive Change Biological: Salt with / without water Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Double (Participant, Investigator)
Masking Description: Salt / placebo will be consumed by capsule under a double-blind procedure
Primary Purpose: Basic Science
Official Title: Hypo-hydration, Mood and Cognition: the Effect of the Colour and Type of Drink
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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 Outcome Measures :
  1. Episodic memory [ Time Frame: Changes from baseline after 90 and 180 minutes ]
    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.

  2. Serial Sevens; test of working memory [ Time Frame: Changes from baseline after 90 and 180 minutes ]
    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

  3. Attention: Arrow Flankers [ Time Frame: Changes from baseline after 90 and 180 minutes ]
    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

  4. Reaction times [ Time Frame: Changes from baseline after 90 and 180 minutes ]
    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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948230


Contacts
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Contact: David Benton, DSc ++441792295607 d.benton@swansea.ac.uk
Contact: Hayley A Young, PhD ++441792295908 h.a.young@swansea.a.cuk

Locations
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United Kingdom
Psychology, Swansea University Recruiting
Swansea, Wales, United Kingdom, sa2 8pp
Contact: Hayley Young, PhD    ++44 1792 295607    h.a.young@swansea.ac.uk   
Contact: David Benton, DSc    ++44 1792 295607    d.benton@swansea.a.cuk   
Principal Investigator: David Benton, DSc         
Swansea University Recruiting
Swansea, Wales, United Kingdom, SA2 8PP
Contact: David Benton, DSc    ++44 1792 295607    d.benton@swansea.ac.uk   
Contact: Sara Long, B.Sc.    ++44 1792 295278    444451@swansea.ac.uk   
Principal Investigator: David Benton, DSc         
Sponsors and Collaborators
Swansea University
Investigators
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Principal Investigator: David Benton, DSc Professor of Psychology
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Responsible Party: David Benton, Professor, Swansea University
ClinicalTrials.gov Identifier: NCT03948230    
Other Study ID Numbers: DB-0519
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No