This study seeks to observe the effects of a proprietary spearmint extract and green tea blend on sleep quality and duration. The study observes the effect of the supplement regarding sleep quality, and mental health.
Sleep disturbance is common in adults and when it persists may result in chronic disease, excess health care utilization, mental disorders, health-risk behaviors, limitations of daily functioning, lost productivity, injury, and mortality (IOM 2006). An estimated 50-70 million adults in the United States have chronic sleep and wakefulness disorders (IOM 2006; Ram 2010) and many more adults report insufficient or deprived sleep. Data from 2014 indicates that approximately 35% of the US population is receiving insufficient sleep (Liu et al., 2016). This is alarming, since insufficient sleep is associated with cardiometabolic disease risk factors including weight gain, obesity, hypertension, diabetes, and inflammation (Grandner et al., 2016), as well as poor daytime functioning and many other outcomes (Grandner, 2017). Cognitive deficits are routinely seen in the laboratory, especially on the Psychomotor Vigilance Task (PVT) (Lim and Dinges, 2010). The National Institutes of Health suggests that adults aim for 7-8 h of sleep per night; however, approximately 28% of adults in the United States reported sleeping 6 h or less based on data from 2008 to 2010 (Schoenborn 2010). A number of strategies are recommended to promote sleep quality and quantity, including a series of behavioral recommendations, such as keeping to a routine sleeping schedule, the timing of eating and physical activity in relation to bedtime, avoidance of stimulants, and maintaining a bedroom environment conducive to sleep (National Sleep Foundation 2015). Although, pharmacologic options are available to treat sleep disturbances, there is consumer interest in natural sleep remedies due to concerns with side effects, dependency, and the safety of prescription medications. The current study seeks observe the effects of a new proprietary blend containing spearmint and green tea extract. It will be the first randomized, double-blind, placebo controlled trial observing the effects of 30 days of 500 mg of a blend containing Spearmint extract and green tea on sleep when administered 30 minutes before bed. This study will utilize Fit-bit (San Francisco, California) (a tool whose use for evaluation of sleep is growing) for daily evaluation of sleep throughout the study in addition to polysomnography, considered by many researchers to be the gold standard for evaluation of sleep outcomes, at chosen timepoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
105
Water extracted spearmint extract and green tea blend
Placebo
University of Arizona Dept of Psychiatry Research facilities
Tucson, Arizona, United States
Sleep Diary- Sleep Latency
Time it takes to fall asleep after the lights have been turned off in minutes (Weekly averages)
Time frame: Change from baseline after 30 days supplementation
Fitbit - Rapid Eye Movement (REM) Sleep
Change in Rapid Eye Movement (REM) Sleep in minutes (Weekly averages)
Time frame: Change from baseline after 30 days supplementation
Sleep Diary -Total Sleep Time
Total Sleep Time in minutes
Time frame: Change from baseline after 30 days supplementation
Sleep Diary-Wake After Sleep Onset
Number of awakenings after sleep onset
Time frame: Change from baseline after 30 days supplementation
Sleep Diary- Sleep Efficiency
ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)
Time frame: Change from baseline after 30 days supplementation
Sleep Diary - Objective Sleep Quality
Sleep Quality (units on a visual analogue scale from 0-10, 0 being the worst outcome, 10 being the best outcome)
Time frame: Change from baseline after 30 days supplementation
Fitbit- Light Sleep
Change in Light Sleep in minutes (Weekly averages)
Time frame: Change from baseline after 30 days supplementation
Fitbit - Total Sleep Time
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Total sleep time in minutes
Time frame: Change from baseline after 30 days supplementation
Fitbit- Sleep Efficiency
ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)
Time frame: Change from baseline after 30 days supplementation
Fitbit- Deep Sleep
Change in Deep Sleep in minutes (Weekly averages)
Time frame: Change from baseline after 30 days supplementation
The Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI): Total Score. Self-report rating scale assessing the severity of insomnia symptoms. Range 0-28 with higher scores indicating a more severe insomnia.
Time frame: Change from baseline after 30 days supplementation
Sustained Attention
Attentional lapses (failure to respond to stimuli within 500 ms) using the psychomotor vigilance test (PVT)
Time frame: Change from baseline after 30 days supplementation
Profile of Mood States (POMS)
Profile of Mood States (POMS): Mood scores. The Profile of Mood States (POMS) is a psychological rating scale used to assess transient, distinct mood states. 65 adjectives rated on 5-point scale 0= not at all; 1=a little; 2=moderately; 3=quite a bit; 4=extremely. Factor analysis: 6 subscales tension-anxiety (9 items, score range: 0-36) depression (15 items, range 0-60) anger-hostility (12 items, range 0-48) vigor-activity (8 items, range 0-32) fatigue (7 items, range 0-28) confusion-bewilderment (7 items, range 0-28) Total mood disturbance (TMD) (range 0-200): TMD = (Tension + Depression + Anger + Fatigue + Confusion) - Vigour
Time frame: Change from baseline after 30 days supplementation
Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS): Total Score. The PSS is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances.Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4 - "Very often." Scores range from 0-56 higher scores indicate greater perceived stress.
Time frame: Change from baseline after 30 days supplementation
The Center for Epidemiological Studies Depression Scale (CESD)
The Center for Epidemiological Studies Depression scale (CESD) Total score. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Time frame: Change from baseline after 30 days supplementation
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI): Total Score. The PSQI is a validated self-rating instrument assessing aspects of sleep quality.Minimum score 0 (better); maximum score 21 (worse) \< or = 5 associated with good sleep quality; \> 5 associated with poor sleep quality.
Time frame: Change from baseline after 30 days supplementation
Sustained Attention
Mean reaction time to stimuli using the psychomotor vigilance test (PVT)
Time frame: Change from baseline after 30 days supplementation