A Study to Assess the Effects of Dietary Supplement Drinks on Sleep, Stress and Mood

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.

Study Overview

• Status: Completed
• Conditions: Stress; Sleep; Mood
• Intervention / Treatment: Dietary supplement: Dietary supplement liquid shot beverage products

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Sago Atlanta - The Palisades Complex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo comparator; Investigational liquid shot beverage product: prototype 60ml product that does not contain study ingredients	Dietary supplement: Dietary supplement liquid shot beverage products; Participants will use their product as instructed for 3 of the 4 study weeks
Experimental: Experimental Product 1; Developmental liquid shot beverage product: prototype 60ml product that contains study ingredients	Dietary supplement: Dietary supplement liquid shot beverage products; Participants will use their product as instructed for 3 of the 4 study weeks
Experimental: Experimental Product 2; Developmental liquid shot beverage product: prototype 60ml product that contains study ingredients	Dietary supplement: Dietary supplement liquid shot beverage products; Participants will use their product as instructed for 3 of the 4 study weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Time points: Week 1, 2, 3 and 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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)	Time points: averages of weeks 1, 2, 3, and 4 (Sunday night - Thursday night consumption only, reported on Monday - Friday mornings)

Collaborators and Investigators

• Sponsor: The Water Street Collective
• Collaborators: British American Tobacco (Investments) Limited; HCD Research
• Investigators: Principal Investigator: Michelle Niedziela, PhD, HCD Research

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HCD J8923

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