MoodNCT03467568
Does Salt Intake Improve Mood
A study testing Sodium Chloride, Water and No water consumed in people with Mood and Salt Intake, run by Swansea University at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mood, Salt Intake
- What is being tested?
- Sodium Chloride, Water and No water consumed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2017to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Psychology, Swansea University
Swansea, Wales, sa2 8pp
Hayley Young, PhD, ++44 1792 295607, h.a.young@swansea.ac.uk
David Benton, DSc, ++44 1792 295607, d.benton@swansea.a.cuk
About this study
Official title: Do Humans Over-consume Salt to Improve Mood
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
Read the 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.
- Conditions
- Mood, Salt Intake
- Being tested
- Sodium Chloride, Placebo capsule, Water, No water consumed
- Keywords
- Mood Salt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium ChlorideDietary supplement
300mg sodium chloride will be provided in a capsule
Placebo capsuleOther
A capsule of identical appearance to that providing salt, but not containing electrolytes, will be consumed
WaterDietary supplement
Twice during the morning a drink of 150ml of water will be consumed
No water consumedBiological
No water will be consumed during the monring
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Sodium Chloride; Dietary 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 Receives: Dietary Supplement: Sodium Chloride; Biological: 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 Receives: Other: Placebo capsule; Dietary Supplement: Water |
| Placebo / no water | Placebo comparator | A capsule containing a placebo will be consumed but no water will be drunk over the morning Receives: Other: Placebo capsule; Biological: No water consumed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to three hours
Secondary outcomes (2)
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
Measured: Up to three hours
Body weight
Changes in body weight over morning. Scales measuring to the nearest 10g will be used
Measured: Up to three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Jan 2017
- Primary completion1 Apr 2018 (estimated)
- Study completion1 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study has four arms. Salt alone; salt plus water; placebo alone, placebo plus water
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Benton, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467568
- Sponsor's protocol ID
- DB-0123-SALT
- Status last verified
- Mar 2018
- First submitted
- 16 Feb 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Humans Over-consume Salt to Improve Mood
- ClinicalTrials.gov ID
- NCT03467568
- Acronym / sponsor ID
- DB-0123-SALT
- Conditions
- Mood, Salt Intake
- Keywords
- Mood Salt
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- The study has four arms. Salt alone; salt plus water; placebo alone, placebo plus water
| Arm | Type | Receives |
|---|---|---|
| Sodium chloride / Water | Active comparator | Dietary Supplement: Sodium Chloride, Dietary Supplement: WaterThe sodium chloride / water arm involves 300mg sodium chloride being consumed in a capsule and on two occasions 150ml of water being drunk |
| Sodium chloride / no water | Active comparator | Dietary Supplement: Sodium Chloride, Biological: No water consumedA capsule containing 300mg of sodium chloride will be consumed but no water will be drunk over the morning |
| Placebo / water | Active comparator | Other: Placebo capsule, Dietary Supplement: WaterA capsule containing a placebo will be consumed and on two occasions 150ml of water will be drunk |
| Placebo / no water | Placebo comparator | Other: Placebo capsule, Biological: No water consumedA capsule containing a placebo will be consumed but no water will be drunk over the morning |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Chloride300mg sodium chloride will be provided in a capsule | Dietary supplement | Sodium chloride / Water, Sodium chloride / no water |
| Placebo capsuleA capsule of identical appearance to that providing salt, but not containing electrolytes, will be consumed | Other | Placebo / no water, Placebo / water |
| WaterTwice during the morning a drink of 150ml of water will be consumed | Dietary supplement | Placebo / water, Sodium chloride / Water |
| No water consumedNo water will be consumed during the monring | Biological | Placebo / no water, Sodium chloride / no water |
Primary outcome
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
2 secondary outcomes
Ratings of thirst
Time frame: Up to three hours
Body weight
Time frame: Up to three hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Chloride, Water and No water consumed in people with Mood and Salt Intake, run by Swansea University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Benton, DSc (++441792295607, d.benton@swansea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood ratings using visual analogue scales (time frame: Up to three hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2018.