- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03467568
Does Salt Intake Improve Mood
Do Humans Over-consume Salt to Improve Mood
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hayley Young, PhD
- Phone Number: ++441792295908
- Email: h.a.young@swansea.a.cuk
Study Locations
-
-
Wales
-
Swansea, Wales, United Kingdom, sa2 8pp
- Recruiting
- Psychology, Swansea University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Self declared in good health -
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Sodium chloride / Water
The sodium chloride / water arm involves 300mg sodium chloride being consumed in a capsule and on two occasions 150ml of water being drunk
|
300mg sodium chloride will be provided in a capsule
Twice during the morning a drink of 150ml of water will be consumed
|
ACTIVE_COMPARATOR: Sodium chloride / no water
A capsule containing 300mg of sodium chloride will be consumed but no water will be drunk over the morning
|
300mg sodium chloride will be provided in a capsule
No water will be consumed during the monring
|
ACTIVE_COMPARATOR: Placebo / water
A capsule containing a placebo will be consumed and on two occasions 150ml of water will be drunk
|
Twice during the morning a drink of 150ml of water will be consumed
A capsule of identical appearance to that providing salt, but not containing electrolytes, will be consumed
|
PLACEBO_COMPARATOR: Placebo / no water
A capsule containing a placebo will be consumed but no water will be drunk over the morning
|
No water will be consumed during the monring
A capsule of identical appearance to that providing salt, but not containing electrolytes, will be consumed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mood ratings using visual analogue scales
Time Frame: Up to three hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ratings of thirst
Time Frame: Up to three hours
|
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
|
Body weight
Time Frame: Up to three hours
|
Changes in body weight over morning.
Scales measuring to the nearest 10g will be used
|
Up to three hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DB-0123-SALT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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