MoodNCT03948230
Hypo-hydration Mood and Cognition
A study testing Salt with / without water in people with Mood and Cognitive Change, run by Swansea University at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood, Cognitive Change
- What is being tested?
- Salt with / without water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jan 2018to 31 Jul 2019
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 30 years
- Non-smokers
- BMI < 30
- By self-report in good health
- Not taking medication for any psychological or other health disorder.
Who cannot join
- Do not meet inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 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
- Recruiting
Swansea University
Swansea, Wales, SA2 8PP
David Benton, DSc, ++44 1792 295607, d.benton@swansea.ac.uk
Sara Long, B.Sc., ++44 1792 295278, 444451@swansea.ac.uk
About this study
Official title: Hypo-hydration, Mood and Cognition: the Effect of the Colour and Type of Drink
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.
Read the detailed description
162 individuals will be subject to a temperature of 30°C for three hours, and mood and cognition monitored. Randomly on two occasions they will consume no drink or 300ml of plain or red colored water. In addition they will take a capsule containing sodium chloride or a placebo. Mood will be monitored using visual analogue scales and a battery of cognitive tests will be completed on three occasions: attention, episodic and working memory, reactions times. Urine osmolality will be measured at the beginning and end of the study and changes in body mass will be recorded. Changes in functioning will be related to the nature of the drink and changes in osmolality and body mass.
- Conditions
- Mood, Cognitive Change
- Being tested
- Salt with / without water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt with / without waterBiological
Drinks with and without a salt containing capsule
| Study group | Role | What they receive |
|---|---|---|
| Sodium chloride / Water | Active comparator | 300mg sodium chloride consumed in a capsule on two occasions with 300ml water Receives: Biological: Salt with / without water |
| Sodium chloride / no water | Active comparator | 300 mg sodium chloride consumed Receives: 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 Receives: Biological: Salt with / without water |
| Placebo / water | Placebo comparator | Placebo consumed in a capsule on two occasions with 300ml water Receives: Biological: Salt with / without water |
| Placebo / no water | Placebo comparator | Placebo capsule consumed Receives: Biological: Salt with / without water |
| Placebo / coloured water | Placebo comparator | Placebo consumed in a capsule on two occasions with 300ml colored water Receives: Biological: Salt with / without water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Changes from baseline after 90 and 180 minutes
Secondary outcomes (4)
Episodic memory
A list of 30 words will be presented after which the subject writes down as many as can be recalled. The resulting score will vary from 0-30.
Measured: Changes from baseline after 90 and 180 minutes
Serial Sevens; test of working memory
28 numbers each of three digits will be presented and the subject indicates whether a subsequent number was exactly seven less. The measure reported is the response time in milli-seconds taken to respond
Measured: Changes from baseline after 90 and 180 minutes
Attention: Arrow Flankers
A series is presented that can be >>>>> or >><>> and the subject has to indicated whether the middle symbol points to the right or left. The measure reported is the time taken to respond in milli-seconds
Measured: Changes from baseline after 90 and 180 minutes
Reaction times
The time to press a button under an illuminated light was recorded in milli-seconds when there was 1, 2, 4, or 8 possible lamps that could be lit. 20 trials were performed with each of the four number of lights.
Measured: Changes from baseline after 90 and 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Jan 2018
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Jul 2019 (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 six arms. Salt alone; salt plus water; salt plus colored water; placebo alone; placebo plus water; placebo plus colored water
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Benton, Swansea University
- Investigators
- David Benton, DSc, Principal investigator, Professor of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948230
- Sponsor's protocol ID
- DB-0519
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 13 May 2019
- Results posted
- 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 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypo-hydration, Mood and Cognition: the Effect of the Colour and Type of Drink
- ClinicalTrials.gov ID
- NCT03948230
- Acronym / sponsor ID
- DB-0519
- Conditions
- Mood, Cognitive Change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 13 May 2019 (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.
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.
Detailed description
162 individuals will be subject to a temperature of 30°C for three hours, and mood and cognition monitored. Randomly on two occasions they will consume no drink or 300ml of plain or red colored water. In addition they will take a capsule containing sodium chloride or a placebo. Mood will be monitored using visual analogue scales and a battery of cognitive tests will be completed on three occasions: attention, episodic and working memory, reactions times. Urine osmolality will be measured at the beginning and end of the study and changes in body mass will be recorded. Changes in functioning will be related to the nature of the drink and changes in osmolality and body mass.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- The study has six arms. Salt alone; salt plus water; salt plus colored water; placebo alone; placebo plus water; placebo plus colored water
| Arm | Type | Receives |
|---|---|---|
| Sodium chloride / Water | Active comparator | Biological: Salt with / without water300mg sodium chloride consumed in a capsule on two occasions with 300ml water |
| Sodium chloride / no water | Active comparator | Biological: Salt with / without water300 mg sodium chloride consumed |
| Sodium chloride / colored water | Active comparator | Biological: Salt with / without water300mg sodium chloride consumed in a capsule on two occasions with 300ml coloured water |
| Placebo / water | Placebo comparator | Biological: Salt with / without waterPlacebo consumed in a capsule on two occasions with 300ml water |
| Placebo / no water | Placebo comparator | Biological: Salt with / without waterPlacebo capsule consumed |
| Placebo / coloured water | Placebo comparator | Biological: Salt with / without waterPlacebo consumed in a capsule on two occasions with 300ml colored water |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 to 30 years
- Non-smokers
- BMI < 30
- By self-report in good health
- Not taking medication for any psychological or other health disorder.
Key exclusion criteria (1 listed)
- Do not meet inclusion criteria
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 |
|---|---|---|
| Salt with / without waterDrinks with and without a salt containing capsule | Biological | Placebo / coloured water, Placebo / no water, Placebo / water, Sodium chloride / Water, Sodium chloride / colored water, Sodium chloride / no water |
Primary outcome
Mood rating: agreeable / hostile
Time frame: Changes from baseline after 90 and 180 minutes
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.
Mood rating: confused / clearheaded
Time frame: Changes from baseline after 90 and 180 minutes
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.
Mood rating: composed / anxious
Time frame: Changes from baseline after 90 and 180 minutes
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.
Mood rating: depressed / elated
Time frame: Changes from baseline after 90 and 180 minutes
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.
Mood rating: tired / energetic
Time frame: Changes from baseline after 90 and 180 minutes
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.
Mood rating: confident / unsure
Time frame: Changes from baseline after 90 and 180 minutes
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.
4 secondary outcomes
Episodic memory
Time frame: Changes from baseline after 90 and 180 minutes
Serial Sevens; test of working memory
Time frame: Changes from baseline after 90 and 180 minutes
Attention: Arrow Flankers
Time frame: Changes from baseline after 90 and 180 minutes
Reaction times
Time frame: Changes from baseline after 90 and 180 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- 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.
David Benton, DSc principal investigator
Professor of Psychology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salt with / without water in people with Mood and Cognitive Change, run by Swansea University at 2 sites 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 5 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 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 rating: agreeable / hostile (time frame: Changes from baseline after 90 and 180 minutes). The study lists 6 primary outcomes in all. 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 13 May 2019.