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

NCT06378567 | Completed

• 1 other identifier: HCD J8923
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Mood; Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Sleep Impairment

  Time points: Weeks 1, 2, 3, and 4

• Insomnia Severity 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

  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 points: Weeks 1, 2, 3, and 4

• Profile of Mood States (POMS 35 Item version)

  Time points: Weeks 1, 2, 3, and 4

Study Arms (3)

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

Experimental Product 1

EXPERIMENTAL

Developmental liquid shot beverage product: prototype 60ml product that contains study ingredients

Dietary Supplement: Dietary supplement liquid shot beverage products

Experimental Product 2

EXPERIMENTAL

Developmental liquid shot beverage product: prototype 60ml product that contains study ingredients

Dietary Supplement: Dietary supplement liquid shot beverage products

Interventions

Dietary supplement liquid shot beverage products DIETARY_SUPPLEMENT

Participants will use their product as instructed for 3 of the 4 study weeks

Experimental Product 1; Experimental Product 2; Placebo comparator

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Water Street Collective: lead
• British American Tobacco (Investments) Limited: collaborator
• HCD Research: collaborator

Study Sites (1)

Sago Atlanta - The Palisades Complex

Atlanta, Georgia, 30328, United States

Location

Study Officials

• Michelle Niedziela, PhD

  HCD Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: August 5, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 1, 2025

Record last verified: 2024-08

Locations

US (1)