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

Stress Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06378567
• Other study ID #: HCD J8923
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: The Water Street Collective
• Contact: Melissa Hall
• Phone: +1 770-396-8700
• Email: connect[@]sago.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 mild/moderate stress.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Generally healthy participants, between 18 and 45 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 8 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 40 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 30.

• 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 market research 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

Related Conditions & MeSH terms

• Mood
• Sleep
• Stress

Intervention

Dietary Supplement:
• Dietary supplement liquid shot beverage products
Participants will use their product as instructed for 3 of the 4 study weeks

Locations

Country	Name	City	State
United States	Sago Atlanta - The Palisades Complex	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
The Water Street Collective	British American Tobacco (Investments) Limited, HCD Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)