CognitionNCT06384586
Investigation of Dietary Supplement Liquid Shot Products on Mental Energy, Cognition (Acuity),and Mood
A study testing Functional energy shot in people with Cognition and Mental Fatigue, run by The Water Street Collective at 1 site in United States.
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 on cognitive task performance and perceived effect measures related to mood and mental energy. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition, Mental Fatigue, Mood
- What is being tested?
- Functional energy shot
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2022to 22 Dec 2022
- 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
- MAIN INCLUSION CRITERIA:
- Participants must be willing to abstain from alcohol, caffeine and exercise starting from the night before each session.
- Participants that, on average, consume between 200 and 500 mgs of caffeine per day.
- Participants that are in good physical and mental health.
- Participants that are willing to come in-person and be within less than 6 feet of study staff for a short period of time.
- 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.
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- 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 consume a normal-sized meal (participant responsible for obtaining or preparing the meal) at least one hour prior to the start of the study session and then fast from food and beverage consumption (except water), for one hour prior to each research session.
Who cannot join
- Participants that are not US citizens or are residents of California.
- 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.), serious health condition (i.e. cancer, etc.), blindness, gastrointestinal sensitivity/condition, depression, insomnia, anxiety, hypertension, PKU (Phenylketonuria), Celiac disease 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 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 are left-handed, have dyscalculia, have paralysis which effects the upper body, or are color-blind, as this could impact their ability to complete the cognitive tasks.
- 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, pseudoephedrine, non-prescription painkillers such as paracetamol (acetaminophen), ibuprofen or aspirin.
- Participants that are taking green tea extract or any diet medications, appetite suppressors or supplements (including, but not limited to, fitness supplements containing green tea extract and caffeine, and workout supplements that are intended to assist with weight loss (such as phentermine)).
- Participants that are pregnant, breastfeeding (or pumping/expressing) or intend to become pregnant in the next six months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Schlesinger Group New Jersey
Iselin, New Jersey, 08330
About this study
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 on cognitive task performance and perceived effect measures related to mood and mental energy. The study will be conducted in healthy participants.
- Conditions
- Cognition, Mental Fatigue, Mood
- Being tested
- Placebo shot, Functional energy shot
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo shotDietary supplement
60ml shot served in an amber bottle and consumed after 40 minutes of baseline assessments
Functional energy shotDietary supplement
60ml shot served in an amber bottle and consumed after 40 minutes of baseline assessments
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo 60 ml Shot, matched in volume, taste and colour and did not contain any active ingredients. 1 shot to be consumed per session Receives: Dietary Supplement: Placebo shot; Dietary Supplement: Functional energy shot |
| Functional Energy shot | Experimental | 60ml functional energy shot contained a proprietary blend of caffeine, ginseng, vitamins and taurine. 1 shot to be consumed per session Receives: Dietary Supplement: Placebo shot; Dietary Supplement: Functional energy shot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental energy via Cognitive Demand Battery (CDB) Performance Index; for the functional energy shot versus placebo shot.
CDB performance index score is a comprised averaged Z scores for the principal performance measure for each of the three tasks: Rapid Visual Information Processing (RVIP) % accuracy, Serial 3s total number correct, Serial 7s total number correct. A higher score signifies performance improvement. Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 120 min post- shot consumption
Secondary outcomes (7)
Mental energy via Cognitive Demand Battery (CDB) Accuracy score for the functional energy shot versus placebo shot.
CDB accuracy score is a comprised averaged Z scores for the principal measures of accuracy of performance for the three tasks: Rapid Visual Information Processing (RVIP) % accuracy; Serial 3s % errors; Serial 7s % errors (the latter two were inverted so that a higher Z score related to better accuracy). A higher score signifies performance improvement.
Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 120 min post- shot consumption
Change in performance on Corsi blocks task for functional energy shot versus placebo
Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 120 min post- shot consumption
Change in performance on Rapid Visual Information Processing (RVIP) for functional energy shot versus placebo
Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 120 min post- shot consumption
Change in performance on Numeric working memory for functional energy shot versus placebo
Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 120 min post- shot consumption
Change in performance on Serial subtraction task for functional energy shot versus placebo
Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 120 min post- shot consumption
Change in Mood via Visual Analogue Scales (VAS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo
0-100 mm subjective rating scale from none to strongest feelings, within Computerised Mental Performance Assessment framework tasks (COMPASS) for mental fatigue, alert, sociable, simulated, jittery, physical energy. The minimum score is 0 and the maximum score is 100.
Measured: Change from baseline to 120 min post- shot consumption
Change in physiological state via Profile Of Mood States (POMS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo
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.
Measured: Change from baseline to 120 min post- shot consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start17 Nov 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CognitionStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 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
- Investigators
- Michelle M Niedziela, PhD, Principal investigator, HCD Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384586
- Sponsor's protocol ID
- CD J8855
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
O'Shea OK, Lawley N, Azzopardi A, Gutkowski A, Niedziela MM, Horn R, Kennedy DO, Adamson J. Acute beneficial effects of a functional energy shot on cognitive performance and mood states during cognitively demanding task performance: a randomized, double-blind, placebo-controlled, crossover trial. Front Nutr. 2025 Jan 9;11:1496092. doi: 10.3389/fnut.2024.1496092. eCollection 2024.
PubMed 39850336
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Dietary Supplement Liquid Shot Products on Mental Energy, Cognition (Acuity),and Mood
- ClinicalTrials.gov ID
- NCT06384586
- Acronym / sponsor ID
- CD J8855
- Conditions
- Cognition, Mental Fatigue, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The Water Street CollectiveIndustry (pharma, biotech, devices)
- Collaborators
- HCD Research, British American Tobacco (Investments) Limited
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 25 Apr 2024 (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 on cognitive task performance and perceived effect measures related to mood and mental energy. The study will be conducted in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo shot, Dietary Supplement: Functional energy shotPlacebo 60 ml Shot, matched in volume, taste and colour and did not contain any active ingredients. 1 shot to be consumed per session |
| Functional Energy shot | Experimental | Dietary Supplement: Placebo shot, Dietary Supplement: Functional energy shot60ml functional energy shot contained a proprietary blend of caffeine, ginseng, vitamins and taurine. 1 shot to be consumed per session |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participants must be willing to abstain from alcohol, caffeine and exercise starting from the night before each session.
- Participants that, on average, consume between 200 and 500 mgs of caffeine per day.
- Participants that are in good physical and mental health.
- Participants that are willing to come in-person and be within less than 6 feet of study staff for a short period of time.
- 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.
Key exclusion criteria (7 listed)
- Participants that are not US citizens or are residents of California.
- 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.), serious health condition (i.e. cancer, etc.), blindness, gastrointestinal sensitivity/condition, depression, insomnia, anxiety, hypertension, PKU (Phenylketonuria), Celiac disease 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 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 are left-handed, have dyscalculia, have paralysis which effects the upper body, or are color-blind, as this could impact their ability to complete the cognitive tasks.
- 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, pseudoephedrine, non-prescription painkillers such as paracetamol (acetaminophen), ibuprofen or aspirin.
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 |
|---|---|---|
| Placebo shot60ml shot served in an amber bottle and consumed after 40 minutes of baseline assessments | Dietary supplement | Functional Energy shot, Placebo |
| Functional energy shot60ml shot served in an amber bottle and consumed after 40 minutes of baseline assessments | Dietary supplement | Functional Energy shot, Placebo |
Primary outcome
Mental energy via Cognitive Demand Battery (CDB) Performance Index; for the functional energy shot versus placebo shot.
Time frame: Change from baseline to 120 min post- shot consumption
CDB performance index score is a comprised averaged Z scores for the principal performance measure for each of the three tasks: Rapid Visual Information Processing (RVIP) % accuracy, Serial 3s total number correct, Serial 7s total number correct. A higher score signifies performance improvement. Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)
7 secondary outcomes
Mental energy via Cognitive Demand Battery (CDB) Accuracy score for the functional energy shot versus placebo shot.
Time frame: Change from baseline to 120 min post- shot consumption
Change in performance on Corsi blocks task for functional energy shot versus placebo
Time frame: Change from baseline to 120 min post- shot consumption
Change in performance on Rapid Visual Information Processing (RVIP) for functional energy shot versus placebo
Time frame: Change from baseline to 120 min post- shot consumption
Change in performance on Numeric working memory for functional energy shot versus placebo
Time frame: Change from baseline to 120 min post- shot consumption
Change in performance on Serial subtraction task for functional energy shot versus placebo
Time frame: Change from baseline to 120 min post- shot consumption
Change in Mood via Visual Analogue Scales (VAS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo
Time frame: Change from baseline to 120 min post- shot consumption
Change in physiological state via Profile Of Mood States (POMS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo
Time frame: Change from baseline to 120 min post- shot 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 25 Apr 2024.
- Derived from this study: PubMed 39850336O'Shea OK, Lawley N, Azzopardi A, Gutkowski A, Niedziela MM, Horn R, Kennedy DO, Adamson J. Acute beneficial effects of a functional energy shot on cognitive performance and mood states during cognitively demanding task performance: a randomized, double-blind, placebo-controlled, crossover trial. Front Nutr. 2025 Jan 9;11:1496092. doi: 10.3389/fnut.2024.1496092. eCollection 2024.
- 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.
Michelle M Niedziela, PhD principal investigator
HCD Research
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 energy shot in people with Cognition and Mental Fatigue, run by The Water Street Collective at 1 site in United States.
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 9 inclusion and 7 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 25 Apr 2024. 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 States. 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?
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?
Mental energy via Cognitive Demand Battery (CDB) Performance Index; for the functional energy shot versus placebo shot. (time frame: Change from baseline to 120 min post- shot consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06384586, which also lists 1 linked publication.
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 25 Apr 2024.