Investigation of a Dietary Supplement Liquid Shot Product on Aspects of Mood Both At Rest and During a Laboratory Stressor Task.

January 15, 2025 updated by: The Water Street Collective

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Participants that, on average, consume less than 400 mgs of caffeine per day and less than 14 units of alcohol per week.
  2. Participants that are in good physical and mental health.
  3. Participants that are willing to come in-person to participate in the research.
  4. 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.
  5. 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.
  6. Participants must be available to complete the study.
  7. 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.

Exclusion Criteria:

  1. Participants that are not UK citizens or residents.
  2. 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.
  3. 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.
  4. 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).
  5. 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.
  6. Participants that currently or in the past have been diagnosed with a chronic cold or sinus condition.
  7. 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.
  8. 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.
  9. Participants that are pregnant, breastfeeding (or pumping/expressing) or intend to become pregnant within the next six months.
  10. Participants that currently use cannabinoid products, smoke cigarettes or use any tobacco or nicotine products.
  11. Participants that are allergic or sensitive to any of the product ingredients.
  12. 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.
  13. 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.
  14. Participants that are currently or have participated in market research in the last 30 days.
  15. 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.
  16. Participants who cannot satisfactorily complete the training/Familiarisation Session with the Investigational Products and the relevant assessments.
  17. Participants who are unwilling or unable to comply with the study requirements and restrictions including those outlined in the Participant Handbook.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: AABB
The order of study product to be consumed over 4 session will be: Placebo, Placebo, Experimental, Experimental
Dietary supplement: Functional Shot
60ml functional energy shot contained a proprietary blend of L-theanine, chamomile, lemon balm, ginseng and vitamins
Dietary supplement: Placebo Shot
Placebo 60 ml Shot, matched in volume, taste and colour and but did not contain any active ingredients
Other: ABBA
The order of study product to be consumed over 4 session will be: Placebo, Experimental, Experimental, Placebo
Dietary supplement: Functional Shot
60ml functional energy shot contained a proprietary blend of L-theanine, chamomile, lemon balm, ginseng and vitamins
Dietary supplement: Placebo Shot
Placebo 60 ml Shot, matched in volume, taste and colour and but did not contain any active ingredients
Other: BAAB
The order of study product to be consumed over 4 session will be: Experimental, Placebo, Placebo, Experimental
Dietary supplement: Functional Shot
60ml functional energy shot contained a proprietary blend of L-theanine, chamomile, lemon balm, ginseng and vitamins
Dietary supplement: Placebo Shot
Placebo 60 ml Shot, matched in volume, taste and colour and but did not contain any active ingredients
Other: BBAA
The order of study product to be consumed over 4 session will be: Experimental, Experimental, Placebo, Placebo
Dietary supplement: Functional Shot
60ml functional energy shot contained a proprietary blend of L-theanine, chamomile, lemon balm, ginseng and vitamins
Dietary supplement: Placebo Shot
Placebo 60 ml Shot, matched in volume, taste and colour and but did not contain any active ingredients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From Baseline to 135 minutes post trial product consumption

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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
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.
From Baseline to 135 minutes post trial product consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Water Street Collective

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
British American Tobacco (Investments) Limited
HCD Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HCD J8880

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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