NCT03948230

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

1.6 years

First QC Date

May 8, 2019

Last Update Submit

May 10, 2019

Conditions

Outcome Measures

Primary Outcomes (6)

  • Mood rating: agreeable / hostile

    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.

    Changes from baseline after 90 and 180 minutes

  • Mood rating: confused / clearheaded

    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.

    Changes from baseline after 90 and 180 minutes

  • Mood rating: composed / anxious

    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.

    Changes from baseline after 90 and 180 minutes

  • Mood rating: depressed / elated

    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.

    Changes from baseline after 90 and 180 minutes

  • Mood rating: tired / energetic

    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.

    Changes from baseline after 90 and 180 minutes

  • Mood rating: confident / unsure

    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.

    Changes from baseline after 90 and 180 minutes

Secondary Outcomes (4)

  • Episodic memory

    Changes from baseline after 90 and 180 minutes

  • Serial Sevens; test of working memory

    Changes from baseline after 90 and 180 minutes

  • Attention: Arrow Flankers

    Changes from baseline after 90 and 180 minutes

  • Reaction times

    Changes from baseline after 90 and 180 minutes

Study Arms (6)

Sodium chloride / Water

ACTIVE COMPARATOR

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

Biological: Salt with / without water

Sodium chloride / no water

ACTIVE COMPARATOR

300 mg sodium chloride consumed

Biological: Salt with / without water

Sodium chloride / colored water

ACTIVE COMPARATOR

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

Biological: Salt with / without water

Placebo / water

PLACEBO COMPARATOR

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

Biological: Salt with / without water

Placebo / no water

PLACEBO COMPARATOR

Placebo capsule consumed

Biological: Salt with / without water

Placebo / coloured water

PLACEBO COMPARATOR

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

Biological: Salt with / without water

Interventions

Drinks with and without a salt containing capsule

Placebo / coloured waterPlacebo / no waterPlacebo / waterSodium chloride / WaterSodium chloride / colored waterSodium chloride / no water

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 30 years
  • Non-smokers
  • BMI \< 30
  • By self-report in good health
  • Not taking medication for any psychological or other health disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Psychology, Swansea University

Swansea, Wales, sa2 8pp, United Kingdom

RECRUITING

Swansea University

Swansea, Wales, SA2 8PP, United Kingdom

RECRUITING

MeSH Terms

Interventions

Salts

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

  • David Benton, DSc

    Professor of Psychology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Benton, DSc

CONTACT

Hayley A Young, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Salt / placebo will be consumed by capsule under a double-blind procedure
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The study has six arms. Salt alone; salt plus water; salt plus colored water; placebo alone; placebo plus water; placebo plus colored water
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 13, 2019

Study Start

January 1, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

May 13, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations