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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
176
Participants will use their product as instructed for 3 of the 4 study weeks
Sago Atlanta - The Palisades Complex
Atlanta, Georgia, United States
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 frame: Time points: Week 1, 2, 3 and 4
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 frame: 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 frame: 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 frame: 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 frame: 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
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Time frame: 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 frame: Time points: averages of weeks 1, 2, 3, and 4 (Sunday night - Thursday night consumption only, reported on Monday - Friday mornings)