Sago Atlanta - The Palisades Complex
Atlanta, Georgia, 30328, United States
NCT Number: NCT06378567
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.
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Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will use their product as instructed for 3 of the 4 study weeks
Time frame: Time points: Week 1, 2, 3 and 4
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 frame: Time points: Weeks 1, 2, 3, and 4
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 frame: Time points: Weeks 1, 2, 3, and 4
Change in Athens Insomnia Scale (AIS) score
Scores range from 0-24, where lower scores indicate lower insomnia severity
Time frame: Time points: Weeks 1, 2, 3, and 4
Change in Restorative Sleep Questionnaire (RSQ) score
Scores range from 0-100, where higher scores indicate better restorative sleep
Time frame: Time points: Weeks 1, 2, 3, and 4
Change in 6-item State Anxiety Inventory (STAI) - State Only portion
Scores range from 6-24, where lower scores indicate lower state anxiety
Time frame: Time points: Weeks 1, 2, 3, and 4
Change in the following POMS scores:
Scores range from 0-20 for each score
Scores for total mood disturbance range from -20 to 100
Time frame: Time points: averages of weeks 1, 2, 3, and 4 (Sunday night - Thursday night consumption only, reported on Monday - Friday mornings)
Change in the following:
The Water Street Collective
Industry
A Between Groups, Placebo-controlled US Home Placement Study Designed to Assess the Effects of Dietary Supplement Drinks on Sleep, Stress and Mood
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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