MoodNCT06785142
Investigation of a Dietary Supplement Liquid Shot Product on Aspects of Mood Both At Rest and During a Laboratory Stressor Task.
A study testing Functional Shot in people with Mood and Stress, run by The Water Street Collective at 1 site in United Kingdom.
Trial summary
This is a single center, randomized, double blind, placebo-controlled, crossover study to determine the acute effect of a developmental dietary supplement liquid shot product of aspect of mood both at rest and during laboratory stressor task. The study will be conducted in healthy adult participants. Read more about this study
- Who is it for?
- Ages 29 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Functional Shot
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2023to 22 Mar 2023
- 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 29 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants that, on average, consume less than 400 mgs of caffeine per day and less than 14 units of alcohol per week.
- Participants that are in good physical and mental health.
- Participants that are willing to come in-person to participate in the research.
- Participants that are able to provide written informed consent to participate in the study and will have agreed to abide by the study restrictions, requirements and protocol.
- Participants must, in the opinion of the Principal Investigator (or designee), demonstrate the ability to comprehend the informed consent form (ICF), be able to communicate well with the Investigator, understand and comply with the requirements of the study, and be judged suitable for the study.
- Participants must be available to complete the study.
- Participants must be willing to fast from food/beverages (other than water) for at least one hour prior to each session, from caffeine for at least three hours prior and from alcohol for at least twelve hours prior.
Who cannot join
- Participants that are not UK citizens or residents.
- Participants that have a medical condition, including but not limited to heartbeat/rhythm irregularities, past heart attacks, been diagnosed with heart disease, seizure disorder, liver condition, blood clotting disorder, endocrine-related medical diagnosis (such as diabetes, thyroid, etc.), asthma/emphysema/COPD, serious health condition (i.e., cancer, etc.), blindness, insomnia, narcolepsy, anxiety, depression, hypertension, or deafness. If a participant has any other medical condition or metabolic condition that prevents them from being able to fast for one hour, they will not be allowed to participate in this study.
- Participants likely to be experiencing fluctuations in mood state such as those that have recently had surgery, changed jobs, experienced the death of a close friend/family member, or are in the process of getting divorced.
- Participants that do not sleep during the night, do not work day-shift hours, or have other factors that impact their sleep schedule such as an inconsistent work schedule, or having disruptions in their sleep due to being the caretaker of a child/adult, dealing with chronic pain or having a sleep disorder (such as Narcolepsy, Insomnia, or Sleep Apnoea).
- Participants that have a loss of taste or smell or are currently suffering from a virus/infection that affects their ability to taste or smell.
- Participants that currently or in the past have been diagnosed with a chronic cold or sinus condition.
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- Participants that have paralysis which effects the upper body, or are colour-blind, as this could impact their ability to complete the tasks in the study.
- Participants that use recreational drugs or that are currently taking medication (except for a contraceptive), or other drugs including non-prescription (over the counter) medications, non-prescription painkillers such as paracetamol (acetaminophen), ibuprofen or aspirin.
- Participants that are pregnant, breastfeeding (or pumping/expressing) or intend to become pregnant within the next six months.
- Participants that currently use cannabinoid products, smoke cigarettes or use any tobacco or nicotine products.
- Participants that are allergic or sensitive to any of the product ingredients.
- Participants that have experienced or that have members of their household that have experienced any of the following symptoms in the past 14 days: cough, shortness of breath or difficulty breathing, fever, chills, repeated shaking with chills (rigors), sore throat, or new loss of taste or smell.
- Participants that have tested positive, or have been in contact with, someone who has tested positive for Coronavirus/COVID-19 in the past 14 days.
- Participants that are currently or have participated in market research in the last 30 days.
- Participants that currently work (or who have an immediate family member who works) for a market research, marketing, advertising, public relations, pharmaceutical, food/beverage or tobacco company.
- Participants who cannot satisfactorily complete the training/Familiarisation Session with the Investigational Products and the relevant assessments.
- Participants who are unwilling or unable to comply with the study requirements and restrictions including those outlined in the Participant Handbook.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Multi-ingredient 'relaxation' Shot on Mood At Rest and During a Laboratory Stressor in Healthy Adults: a Randomized, Double-blind, Placebo-controlled, Crossover Trial
This is a single center, randomized, double blind, placebo-controlled, crossover study to determine the acute effect of a developmental dietary supplement liquid shot product of aspect of mood both at rest and during laboratory stressor task. The study will be conducted in healthy adult participants.
- Being tested
- Functional Shot, Placebo Shot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional ShotDietary supplement
60ml functional energy shot contained a proprietary blend of L-theanine, chamomile, lemon balm, ginseng and vitamins
Placebo ShotDietary supplement
Placebo 60 ml Shot, matched in volume, taste and colour and but did not contain any active ingredients
| Study group | Role | What they receive |
|---|---|---|
| AABB | Other | The order of study product to be consumed over 4 session will be: Placebo, Placebo, Experimental, Experimental Receives: Dietary Supplement: Functional Shot; Dietary Supplement: Placebo Shot |
| ABBA | Other | The order of study product to be consumed over 4 session will be: Placebo, Experimental, Experimental, Placebo Receives: Dietary Supplement: Functional Shot; Dietary Supplement: Placebo Shot |
| BAAB | Other | The order of study product to be consumed over 4 session will be: Experimental, Placebo, Placebo, Experimental Receives: Dietary Supplement: Functional Shot; Dietary Supplement: Placebo Shot |
| BBAA | Other | The order of study product to be consumed over 4 session will be: Experimental, Experimental, Placebo, Placebo Receives: Dietary Supplement: Functional Shot; Dietary Supplement: Placebo Shot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the State-Trait Anxiety Inventory up to 135 minutes for the functional shot versus placebo shot.
The STAI 'State' subscale contains 6 statements each responded to with a 4-point Likert scale. Scores range from 6-24, where higher scores indicate higher anxiety.
Measured: From Baseline to 135 minutes post trial product consumption
Secondary outcomes (4)
Change from Baseline in Mood via Visual Analogue Mood Scales (VAMS) up to 135 minutes for the functional shot versus placebo shot.
Comprising of 18 visual analogue scales anchored by pairs of antonymic mood/state adjectives (e.g. Alert - Inattentive; Lethargic - Energetic) on 0-100% line. The individual item scores are combined to give an average (% along the line) score on three factors that had previously been derived by factor analysis: 'Alertness', 'Tranquility' and 'Stress'. Higher scores indicate a higher level of each factor.
Measured: From Baseline to 135 minutes post trial product consumption
Change from Baseline in Mood via Visual Analogue Scales (VAS) up to 135 minutes for the functional shot versus placebo shot.
0-100 mm subjective rating scale from none to strongest feelings, for clam, sleepy, nervous and in control. Higher scores indicate a higher level of each factor.
Measured: From Baseline to 135 minutes post trial product consumption
Change from Baseline in physiological state via POMS up to 135 minutes for the functional shot versus placebo shot.
a 37-item inventory, the individual item scores of which are collapsed into six dimensions of mood: anger/hostility, confusion/bewilderment, depression/dejection, fatigue/inertia, tension/anxiety, and vigour/activity. Higher scores indicate a higher level of each factor.
Measured: From Baseline to 135 minutes post trial product consumption
Change from Baseline in physiological state via Self-Assessment Manikin up to 135 minutes for the functional shot versus placebo shot.
The three single-item scales, each comprising nine simple line-drawn human figures with titrated emotional connotations, measure the participants current emotional position between happiness and sadness (Pleasure scale), relaxed and excited (Arousal scale), and feeling no-control to feeling in full-control (Dominance scale). Higher scores indicate a higher level of each factor.
Measured: From Baseline to 135 minutes post trial product consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start14 Jan 2023
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Water Street Collective
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HCD Research, British American Tobacco (Investments) Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785142
- Sponsor's protocol ID
- HCD J8880
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Multi-ingredient 'relaxation' Shot on Mood At Rest and During a Laboratory Stressor in Healthy Adults: a Randomized, Double-blind, Placebo-controlled, Crossover Trial
- ClinicalTrials.gov ID
- NCT06785142
- Acronym / sponsor ID
- HCD J8880
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The Water Street CollectiveIndustry (pharma, biotech, devices)
- Collaborators
- HCD Research, British American Tobacco (Investments) Limited
- Study start
- 14 Jan 2023 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 21 Jan 2025 (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.
This is a single center, randomized, double blind, placebo-controlled, crossover study to determine the acute effect of a developmental dietary supplement liquid shot product of aspect of mood both at rest and during laboratory stressor task. The study will be conducted in healthy adult participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AABB | Other | Dietary Supplement: Functional Shot, Dietary Supplement: Placebo ShotThe order of study product to be consumed over 4 session will be: Placebo, Placebo, Experimental, Experimental |
| ABBA | Other | Dietary Supplement: Functional Shot, Dietary Supplement: Placebo ShotThe order of study product to be consumed over 4 session will be: Placebo, Experimental, Experimental, Placebo |
| BAAB | Other | Dietary Supplement: Functional Shot, Dietary Supplement: Placebo ShotThe order of study product to be consumed over 4 session will be: Experimental, Placebo, Placebo, Experimental |
| BBAA | Other | Dietary Supplement: Functional Shot, Dietary Supplement: Placebo ShotThe order of study product to be consumed over 4 session will be: Experimental, Experimental, Placebo, Placebo |
Who may qualify
- Ages
- 29 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants that, on average, consume less than 400 mgs of caffeine per day and less than 14 units of alcohol per week.
- Participants that are in good physical and mental health.
- Participants that are willing to come in-person to participate in the research.
- Participants that are able to provide written informed consent to participate in the study and will have agreed to abide by the study restrictions, requirements and protocol.
- Participants must, in the opinion of the Principal Investigator (or designee), demonstrate the ability to comprehend the informed consent form (ICF), be able to communicate well with the Investigator, understand and comply with the requirements of the study, and be judged suitable for the study.
Key exclusion criteria (17 listed)
- Participants that are not UK citizens or residents.
- Participants that have a medical condition, including but not limited to heartbeat/rhythm irregularities, past heart attacks, been diagnosed with heart disease, seizure disorder, liver condition, blood clotting disorder, endocrine-related medical diagnosis (such as diabetes, thyroid, etc.), asthma/emphysema/COPD, serious health condition (i.e., cancer, etc.), blindness, insomnia, narcolepsy, anxiety, depression, hypertension, or deafness. If a participant has any other medical condition or metabolic condition that prevents them from being able to fast for one hour, they will not be allowed to participate in this study.
- Participants likely to be experiencing fluctuations in mood state such as those that have recently had surgery, changed jobs, experienced the death of a close friend/family member, or are in the process of getting divorced.
- Participants that do not sleep during the night, do not work day-shift hours, or have other factors that impact their sleep schedule such as an inconsistent work schedule, or having disruptions in their sleep due to being the caretaker of a child/adult, dealing with chronic pain or having a sleep disorder (such as Narcolepsy, Insomnia, or Sleep Apnoea).
- Participants that have a loss of taste or smell or are currently suffering from a virus/infection that affects their ability to taste or smell.
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 |
|---|---|---|
| Functional Shot60ml functional energy shot contained a proprietary blend of L-theanine, chamomile, lemon balm, ginseng and vitamins | Dietary supplement | AABB, ABBA, BAAB, BBAA |
| Placebo ShotPlacebo 60 ml Shot, matched in volume, taste and colour and but did not contain any active ingredients | Dietary supplement | AABB, ABBA, BAAB, BBAA |
Primary outcome
Change from Baseline in the State-Trait Anxiety Inventory up to 135 minutes for the functional shot versus placebo shot.
Time frame: From Baseline to 135 minutes post trial product consumption
The STAI 'State' subscale contains 6 statements each responded to with a 4-point Likert scale. Scores range from 6-24, where higher scores indicate higher anxiety.
4 secondary outcomes
Change from Baseline in Mood via Visual Analogue Mood Scales (VAMS) up to 135 minutes for the functional shot versus placebo shot.
Time frame: From Baseline to 135 minutes post trial product consumption
Change from Baseline in Mood via Visual Analogue Scales (VAS) up to 135 minutes for the functional shot versus placebo shot.
Time frame: From Baseline to 135 minutes post trial product consumption
Change from Baseline in physiological state via POMS up to 135 minutes for the functional shot versus placebo shot.
Time frame: From Baseline to 135 minutes post trial product consumption
Change from Baseline in physiological state via Self-Assessment Manikin up to 135 minutes for the functional shot versus placebo shot.
Time frame: From Baseline to 135 minutes post trial product consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Shot in people with Mood and Stress, run by The Water Street Collective 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 7 inclusion and 17 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: finished, as of the sponsor's last update on 21 Jan 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the State-Trait Anxiety Inventory up to 135 minutes for the functional shot versus placebo shot. (time frame: From Baseline to 135 minutes post trial product consumption). 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 21 Jan 2025.