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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03467568
Other study ID # DB-0123-SALT
Secondary ID
Status Recruiting
Phase N/A
First received February 16, 2018
Last updated March 9, 2018
Start date January 1, 2017
Est. completion date April 1, 2018

Study information

Verified date March 2018
Source Swansea University
Contact David Benton, DSc
Phone ++441792295607
Email d.benton@swansea.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Study 1. 120 young adults will be were recruited. They will arrive in the laboratory at 0900 having consumed their normal breakfast. Over the morning they will reported their mood by responding to one hundred millimetre visual analogue scales anchored with the words: Composed/Anxious; Hostile/Agreeable; Elated/Depressed; Unsure/Confident; Energetic/Tired; Confused/Clearheaded. These dimensions of mood came from the factor analysis that formed the basis of the Profile of Mood State questionnaire. An overall measure of mood will be calculated. .

Randomly they will receive either a 150ml glass of water, or an equivalent volume of water containing electrolytes (in total 150mg sodium chloride and 45mg potassium chloride (Gatorade G2 Low calorie (34 kcal) Thirst Quencher, Pepsico). This drink will be consumed for a first time after 50 minutes, and a second time after 140 minutes. A estimate of habitual salt preference will be gained by responding to questions concerning the adding of salt to meals and a preference for salty foods.

Study 2: One hundred and twenty young adults will be recruited. A second study attempts to replicate the first in a double-blind trial where the taste of salt was hidden by using a capsule. . Participants will be assigned to one of four experimental conditions; 1) swallowed placebo capsules; 2) swallowed capsules containing electrolyte (300mg sodium chloride); 3) received placebo capsules and plain water; 4) received capsules containing electrolyte and plain water. Each drink will be 150ml of water. The allocation of the type of capsule will be carried out double-blind, determined by computer generated random numbers.

Otherwise the procedure will be identical to study one.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date April 1, 2018
Est. primary completion date April 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Self declared in good health -

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Sodium Chloride
300mg sodium chloride will be provided in a capsule
Other:
Placebo capsule
A capsule of identical appearance to that providing salt, but not containing electrolytes, will be consumed
Dietary Supplement:
Water
Twice during the morning a drink of 150ml of water will be consumed
Biological:
No water consumed
No water will be consumed during the monring

Locations

Country Name City State
United Kingdom Psychology, Swansea University Swansea Wales

Sponsors (1)

Lead Sponsor Collaborator
Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Ratings of thirst Rating made using a visual analogue scale responding to the question how thirsty do you feel right now? With a high score indicated greater thrist Up to three hours
Secondary Body weight Changes in body weight over morning. Scales measuring to the nearest 10g will be used Up to three hours
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