SleepNCT06378567
A Study to Assess the Effects of Dietary Supplement Drinks on Sleep, Stress and Mood
A study testing Dietary supplement liquid shot beverage products in people with Sleep and Mood, run by The Water Street Collective at 1 site in United States.
Trial summary
A home placement, randomized, double blind, placebo-controlled, study to determine the effect of dietary liquid shot beverage products on self-reported measures of sleep, stress and mood on generally healthy participants with current self-reported mild/moderate sleep difficulties (but not clinical insomnia) and… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- Dietary supplement liquid shot beverage products
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2024to 1 Sep 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy participants, between 18 and 55 years of age.
- Participants who are not clinical insomniacs (as determined by a medical professional in the last 12 months, or who meets the ISQ criteria in screening).
- Participants who are in good self-reported physical and mental health.
- Participants with current self-reported mild/moderate sleep difficulties wishing to improve their sleep (as determined by an AIS score of 7 or more, but 14 or less).
- Participants with current self-reported mild/moderate stress wishing to improve their stress level (as determined by a PSQ raw score of 38 or higher).
- Participants that are willing to not use other new dietary supplements throughout the study but continue to use their normal dietary supplements (if any) as per their normal routine.
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- Participants who can 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), 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 abstain from alcohol after 6 pm each day.
- Participants must consume less than 400 mgs of caffeine per day.
- Participants must consume 7 servings or less of alcohol in a typical week
Who cannot join
- Participants that are not US 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, autoimmune disease, kidney disorder or impairment, chronic sinus condition, 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.
- Participants that have a BMI outside the range of 18.5 to 35.
- 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 dealing with chronic pain or having a sleep disorder (such as Night Terrors, Narcolepsy, Insomnia, or Sleep Apnoea).
- Participants that do not have any difficulty sleeping.
- Participants that use recreational drugs or that are currently taking prescription medication (except for a contraceptive).
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- 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 are currently or have participated in sleep-related studies or any product research studies 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 that use sleep aids every night or multiple times a week.
- Participants who are unwilling or unable to comply with the study requirements and restrictions including those outlined in the Participant Handbook.
- Participants that are traveling over the next 4-6 weeks, to an extent where the time zone difference would impact their regular sleep schedule
Trial locations and contacts
1 site in 1 country.
United States1 site
Sago Atlanta - The Palisades Complex
Atlanta, Georgia, 30328
About this study
Official title: A Between Groups, Placebo-controlled US Home Placement Study Designed to Assess the Effects of Dietary Supplement Drinks on Sleep, Stress and Mood
A home placement, randomized, double blind, placebo-controlled, study to determine the effect of dietary liquid shot beverage products on self-reported measures of sleep, stress and mood on generally healthy participants with current self-reported mild/moderate sleep difficulties (but not clinical insomnia) and mild/moderate stress.
- Being tested
- Dietary supplement liquid shot beverage products
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement liquid shot beverage productsDietary supplement
Participants will use their product as instructed for 3 of the 4 study weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo comparator | Placebo comparator | Investigational liquid shot beverage product: prototype 60ml product that does not contain study ingredients Receives: Dietary Supplement: Dietary supplement liquid shot beverage products |
| Experimental Product 1 | Experimental | Developmental liquid shot beverage product: prototype 60ml product that contains study ingredients Receives: Dietary Supplement: Dietary supplement liquid shot beverage products |
| Experimental Product 2 | Experimental | Developmental liquid shot beverage product: prototype 60ml product that contains study ingredients Receives: Dietary Supplement: Dietary supplement liquid shot beverage products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Disturbance
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) - Sleep disturbance 8A
Scores range from 8-40, where lower scores indicate lower sleep disturbance
Measured: Time points: Week 1, 2, 3 and 4
Secondary outcomes (6)
Sleep Impairment
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) - Sleep-related impairment score 8A
Scores range from 8-40, where lower scores indicate lower sleep impairment
Measured: Time points: Weeks 1, 2, 3, and 4
Insomnia Severity Scores range from 0-24, where lower scores indicate lower insomnia severity
Change in Athens Insomnia Scale (AIS) score
Scores range from 0-24, where lower scores indicate lower insomnia severity
Measured: Time points: Weeks 1, 2, 3, and 4
Restorative Sleep Scores range from 0-100, where higher scores indicate better restorative sleep
Change in Restorative Sleep Questionnaire (RSQ) score
Scores range from 0-100, where higher scores indicate better restorative sleep
Measured: Time points: Weeks 1, 2, 3, and 4
Contentedness/Anxiety Scores range from 6-24, where lower scores indicate lower levels of state anxiety
Change in 6-item State Anxiety Inventory (STAI) - State Only portion
Scores range from 6-24, where lower scores indicate lower state anxiety
Measured: Time points: Weeks 1, 2, 3, and 4
Profile of Mood States (POMS 35 Item version)
Change in the following POMS scores:
- Anger
- Confusion
- Depression
- Fatigue
- Tension
- Vigor
- Friendliness
Scores range from 0-20 for each score
- Total Mood Disturbance
Scores for total mood disturbance range from -20 to 100
Measured: Time points: Weeks 1, 2, 3, and 4
Daily Sleep diary
Change in the following:
- Total sleep time the previous night (self-report estimated in 15 minute increments)
- Satisfaction with how long it took to fall asleep the previous night (7-point likert scale, where higher scores indicate higher satisfaction with how long it took to fall asleep)
- Time spent awake during the night (self-reported estimate in estimated minutes/hours)
- Sleep quality VAS (scores range from 0-100, where higher scores indicate higher perceived sleep quality)
- Relaxation upon waking VAS (scores range from 0-100, where higher scores indicate higher relaxation)
- Refreshment upon waking VAS (scores range from 0-100, where higher scores indicate higher refreshment)
- Alertness upon waking VAS (scores range from 0-100, where higher scores indicate higher alertness)
Measured: Time points: averages of weeks 1, 2, 3, and 4 (Sunday night - Thursday night consumption only, reported on Monday - Friday mornings)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start5 Aug 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Water Street Collective
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- British American Tobacco (Investments) Limited, HCD Research
- Responsible party
- Sponsor
- Investigators
- Michelle Niedziela, PhD, Principal investigator, HCD Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378567
- Sponsor's protocol ID
- HCD J8923
- Status last verified
- Aug 2024
- First submitted
- 17 Apr 2024
- Last updated
- 1 Apr 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Between Groups, Placebo-controlled US Home Placement Study Designed to Assess the Effects of Dietary Supplement Drinks on Sleep, Stress and Mood
- ClinicalTrials.gov ID
- NCT06378567
- Acronym / sponsor ID
- HCD J8923
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- The Water Street CollectiveIndustry (pharma, biotech, devices)
- Collaborators
- British American Tobacco (Investments) Limited, HCD Research
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 22 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.
A home placement, randomized, double blind, placebo-controlled, study to determine the effect of dietary liquid shot beverage products on self-reported measures of sleep, stress and mood on generally healthy participants with current self-reported mild/moderate sleep difficulties (but not clinical insomnia) and mild/moderate stress.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Placebo comparator | Placebo comparator | Dietary Supplement: Dietary supplement liquid shot beverage productsInvestigational liquid shot beverage product: prototype 60ml product that does not contain study ingredients |
| Experimental Product 1 | Experimental | Dietary Supplement: Dietary supplement liquid shot beverage productsDevelopmental liquid shot beverage product: prototype 60ml product that contains study ingredients |
| Experimental Product 2 | Experimental | Dietary Supplement: Dietary supplement liquid shot beverage productsDevelopmental liquid shot beverage product: prototype 60ml product that contains study ingredients |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Generally healthy participants, between 18 and 55 years of age.
- Participants who are not clinical insomniacs (as determined by a medical professional in the last 12 months, or who meets the ISQ criteria in screening).
- Participants who are in good self-reported physical and mental health.
- Participants with current self-reported mild/moderate sleep difficulties wishing to improve their sleep (as determined by an AIS score of 7 or more, but 14 or less).
- Participants with current self-reported mild/moderate stress wishing to improve their stress level (as determined by a PSQ raw score of 38 or higher).
Key exclusion criteria (14 listed)
- Participants that are not US 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, autoimmune disease, kidney disorder or impairment, chronic sinus condition, 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.
- Participants that have a BMI outside the range of 18.5 to 35.
- 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 dealing with chronic pain or having a sleep disorder (such as Night Terrors, Narcolepsy, Insomnia, or Sleep Apnoea).
- Participants that do not have any difficulty sleeping.
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 |
|---|---|---|
| Dietary supplement liquid shot beverage productsParticipants will use their product as instructed for 3 of the 4 study weeks | Dietary supplement | Experimental Product 1, Experimental Product 2, Placebo comparator |
Primary outcome
Sleep Disturbance
Time frame: Time points: Week 1, 2, 3 and 4
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) - Sleep disturbance 8A Scores range from 8-40, where lower scores indicate lower sleep disturbance
6 secondary outcomes
Sleep Impairment
Time frame: Time points: Weeks 1, 2, 3, and 4
Insomnia Severity Scores range from 0-24, where lower scores indicate lower insomnia severity
Time frame: Time points: Weeks 1, 2, 3, and 4
Restorative Sleep Scores range from 0-100, where higher scores indicate better restorative sleep
Time frame: Time points: Weeks 1, 2, 3, and 4
Contentedness/Anxiety Scores range from 6-24, where lower scores indicate lower levels of state anxiety
Time frame: Time points: Weeks 1, 2, 3, and 4
Profile of Mood States (POMS 35 Item version)
Time frame: Time points: Weeks 1, 2, 3, and 4
Daily Sleep diary
Time frame: Time points: averages of weeks 1, 2, 3, and 4 (Sunday night - Thursday night consumption only, reported on Monday - Friday mornings)
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 1 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Healthy Adult Participants
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 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 Dietary supplement liquid shot beverage products in people with Sleep and Mood, 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 12 inclusion and 14 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 1 Apr 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 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?
Sleep Disturbance (time frame: Time points: Week 1, 2, 3 and 4). 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 1 Apr 2025.