Clinical trial NCT06378567: A Study to Assess the Effects of Dietary Supplement Drinks on Sleep, Stress and Mood
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Mood
Stress
Lead sponsor: The Water Street Collective
Sponsor class: INDUSTRY
Collaborators: name: British American Tobacco (Investments) Limited
name: HCD Research
First posted: 2024-04-22
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: OTHER

Brief 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 mild/moderate stress.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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

Exclusion Criteria:

* 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).
* 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

Primary outcomes:
measure: Sleep Disturbance
timeFrame: Time points: Week 1, 2, 3 and 4
Secondary outcomes:
measure: Sleep Impairment
timeFrame: Time points: Weeks 1, 2, 3, and 4
measure: Insomnia Severity Scores range from 0-24, where lower scores indicate lower insomnia severity
timeFrame: Time points: Weeks 1, 2, 3, and 4
measure: Restorative Sleep Scores range from 0-100, where higher scores indicate better restorative sleep
timeFrame: Time points: Weeks 1, 2, 3, and 4
measure: Contentedness/Anxiety Scores range from 6-24, where lower scores indicate lower levels of state anxiety
timeFrame: Time points: Weeks 1, 2, 3, and 4
measure: Profile of Mood States (POMS 35 Item version)
timeFrame: Time points: Weeks 1, 2, 3, and 4
measure: Daily Sleep diary
timeFrame: Time points: averages of weeks 1, 2, 3, and 4 (Sunday night - Thursday night consumption only, reported on Monday - Friday mornings)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Sago Atlanta - The Palisades Complex
state: Georgia
Study officials:
affiliation: HCD Research
name: Michelle Niedziela, PhD
role: PRINCIPAL_INVESTIGATOR
References: