A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the efficacy of Rest-ZZZ in healthy participants with difficulty falling asleep or staying a sleep. The study will have 3 study periods. During each study period, eligible participants will consume either Rest-ZZZ, comparator product, or placebo for 7 days during each study period (1 product per study period), with a 1-week washout period in between each period. The primary objective is the comparison in sleep quality using a sleep quality questionnaire from pre-supplement to Day 7 between the Rest-ZZZ, comparator, and placebo. Other study outcomes include the change in quality of life, profile of mood states (POMS), and safety outcomes such as vital signs, clinical chemistry and hematological markers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
27
A dietary supplement containing melatonin, valerian root, chamomile, passion flower, GABA, hawthorn berry, and lemon balm
DIN 02229960 encapsulated for blinding purposes
No active ingredients
KGK Science Inc.
London, Ontario, Canada
Comparison of change in sleep quality assessed by the sleep quality (SQ) questionnaire between Rest-ZZZ, comparator, and placebo from pre-supplementation to after 7 days of supplementation
The SQ Questionnaire will provide an index for the following parameters: sleep efficiency, perceived sleep debt, and sleep difficulty. In the sleep difficulty section, there are 7 questions asking participants to rate on a scale of 1 to 5 (1 = Strongly Disagree, 2 = Disagree, 3 = No Opinion, 4 = Agree, 5 = Strongly agree). There are 7 questions in the sleep-related quality of life asking participants to rate on a scale of 1 to 5 (1 = Strongly Disagree, 2 = Disagree, 3 = No Opinion, 4 = Agree, 5 = Strongly agree). In both cases, a higher score corresponds to more sleep difficulty and worse sleep-related quality of life (one question in the sleep-related quality of life section has reverse scoring).
Time frame: 7 days
Comparison between Rest-ZZZ, comparator, and placebo in the change in quality of life assessed by a quality of life questionnaire from pre-supplementation to after 7 days of supplementation
The quality of life questionnaire will be used to measure discomfort and feelings of well being. This questionnaire has 31 questions assessing different areas in quality of life with various scales.
Time frame: 7 days
Comparison between Rest-ZZZ, comparator, and placebo in the change in Profile of Mood States (POMS) questionnaire from pre-supplementation to after 7 of supplementation
The POMS index is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials including other exercise related studies. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Participants will be instructed by a clinic coordinator to respond to the questionnaire based on the past week.
Time frame: 7 days
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