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

Last updated: March 25, 2025
Sponsor: The Water Street Collective
Overall Status: Completed

Phase

N/A

Condition

Stress

Treatment

Dietary supplement liquid shot beverage products

Clinical Study ID

NCT06378567
HCD J8923
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Generally healthy participants, between 18 and 55 years of age.

  • Participants who are not clinical insomniacs (as determined by a medicalprofessional 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 toimprove 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 improvetheir stress level (as determined by a PSQ raw score of 38 or higher).

  • Participants that are willing to not use other new dietary supplements throughoutthe study but continue to use their normal dietary supplements (if any) as per theirnormal routine.

  • Participants who can provide written informed consent to participate in the studyand 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), understandand 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

Exclusion Criteria:

  • Participants that are not US citizens or residents.

  • Participants that have a medical condition, including but not limited toheartbeat/rhythm irregularities, past heart attacks, been diagnosed with heartdisease, seizure disorder, autoimmune disease, kidney disorder or impairment,chronic sinus condition, liver condition, blood clotting disorder, endocrine-relatedmedical diagnosis (such as diabetes, thyroid, etc.), asthma/emphysema/COPD, serioushealth 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, orhave other factors that impact their sleep schedule such as an inconsistent workschedule, or dealing with chronic pain or having a sleep disorder (such as NightTerrors, Narcolepsy, Insomnia, or Sleep Apnoea).

  • Participants that do not have any difficulty sleeping.

  • Participants that use recreational drugs or that are currently taking prescriptionmedication (except for a contraceptive).

  • Participants that are pregnant, breastfeeding (or pumping/expressing) or intend tobecome pregnant within the next six months.

  • Participants that currently use cannabinoid products, smoke cigarettes or use anytobacco 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 anyproduct 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 andrestrictions including those outlined in the Participant Handbook.

  • Participants that are traveling over the next 4-6 weeks, to an extent where the timezone difference would impact their regular sleep schedule

Study Design

Total Participants: 176
Treatment Group(s): 1
Primary Treatment: Dietary supplement liquid shot beverage products
Phase:
Study Start date:
August 05, 2024
Estimated Completion Date:
September 01, 2024

Connect with a study center

  • Sago Atlanta - The Palisades Complex

    Atlanta, Georgia 30328
    United States

    Site Not Available

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