NCT03467568

Brief Summary

Humans display a preference for salt although the reasons remain unclear. The aim was to examine the hypothesis that salt may enhance mood. The study compares the drinking of water with and without electrolytes (either dissolved in water or by capsule). Mood was rated over a period of 155 minutes

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

March 16, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

February 16, 2018

Last Update Submit

March 9, 2018

Conditions

Keywords

Mood Salt

Outcome Measures

Primary Outcomes (1)

  • Mood ratings using visual analogue scales

    On a hundred millimetre scale ratings will be made of with the two ends anchored with the words Agreeable/Hostile, Confused/clearheaded; composed/anxious; depressed/elated; confident/unsure; tired/energetic. Each scales produces a score between 0 and 100. When added to create a total mood score the ratings vary between zero and six hundred with a higher score indicating a better mood

    Up to three hours

Secondary Outcomes (2)

  • Ratings of thirst

    Up to three hours

  • Body weight

    Up to three hours

Study Arms (4)

Sodium chloride / Water

ACTIVE COMPARATOR

The sodium chloride / water arm involves 300mg sodium chloride being consumed in a capsule and on two occasions 150ml of water being drunk

Dietary Supplement: Sodium ChlorideDietary Supplement: Water

Sodium chloride / no water

ACTIVE COMPARATOR

A capsule containing 300mg of sodium chloride will be consumed but no water will be drunk over the morning

Dietary Supplement: Sodium ChlorideBiological: No water consumed

Placebo / water

ACTIVE COMPARATOR

A capsule containing a placebo will be consumed and on two occasions 150ml of water will be drunk

Other: Placebo capsuleDietary Supplement: Water

Placebo / no water

PLACEBO COMPARATOR

A capsule containing a placebo will be consumed but no water will be drunk over the morning

Other: Placebo capsuleBiological: No water consumed

Interventions

Sodium ChlorideDIETARY_SUPPLEMENT

300mg sodium chloride will be provided in a capsule

Sodium chloride / WaterSodium chloride / no water

A capsule of identical appearance to that providing salt, but not containing electrolytes, will be consumed

Placebo / no waterPlacebo / water
WaterDIETARY_SUPPLEMENT

Twice during the morning a drink of 150ml of water will be consumed

Placebo / waterSodium chloride / Water

No water will be consumed during the monring

Placebo / no waterSodium chloride / no water

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychology, Swansea University

Swansea, Wales, sa2 8pp, United Kingdom

RECRUITING

MeSH Terms

Interventions

Sodium ChlorideWater

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsHydroxidesAlkaliesAnionsIonsElectrolytesOxidesOxygen Compounds

Central Study Contacts

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 four arms. Salt alone; salt plus water; placebo alone, placebo plus water
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 16, 2018

First Posted

March 16, 2018

Study Start

January 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

March 16, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations