Investigational Test of a New Sleep Supplement

Not Applicable

Completed

Conditions: Sleep
Mood
Cognitive Performance

Interventions: Other: Control
Dietary Supplement: Proprietary Spearmint Extract Blend

Registration Number: NCT03567343

Lead Sponsor: University of Arizona

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Subjects randomized into the active treatment group will be asked to consume 500 mg/day of the excipient, microcrystalline cellulose by mouth every night 30 mins before bed, complete a sleep diary upon waking and wear a Fitbit Charge 2 device for sleep monitoring for 30 days. A subset of this group will undergo 2 overnight polysomnography studies
Proprietary Spearmint Extract Blend	Proprietary Spearmint Extract Blend	Subjects randomized into the active treatment group will be asked to consume 500 mg/day of the Proprietary Spearmint Extract Blend blend by mouth every night 30 mins before bed, complete a sleep diary upon waking and wear a Fitbit Charge 2 device for sleep monitoring for 30 days. A subset of this group will undergo 2 overnight polysomnography studies

Primary Outcome Measures

Name	Time	Method
Sleep Diary- Sleep Latency	Change from baseline after 30 days supplementation	Time it takes to fall asleep after the lights have been turned off in minutes (Weekly averages)
Fitbit - Rapid Eye Movement (REM) Sleep	Change from baseline after 30 days supplementation	Change in Rapid Eye Movement (REM) Sleep in minutes (Weekly averages)

Secondary Outcome Measures

Name	Time	Method
Sleep Diary- Sleep Efficiency	Change from baseline after 30 days supplementation	ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)
Sleep Diary - Objective Sleep Quality	Change from baseline after 30 days supplementation	Sleep Quality (units on a visual analogue scale from 0-10, 0 being the worst outcome, 10 being the best outcome)
Fitbit - Total Sleep Time	Change from baseline after 30 days supplementation	Total sleep time in minutes
Perceived Stress Scale (PSS)	Change from baseline after 30 days supplementation	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.
The Center for Epidemiological Studies Depression Scale (CESD)	Change from baseline after 30 days supplementation	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.
Sleep Diary -Total Sleep Time	Change from baseline after 30 days supplementation	Total Sleep Time in minutes
Sleep Diary-Wake After Sleep Onset	Change from baseline after 30 days supplementation	Number of awakenings after sleep onset
Fitbit- Light Sleep	Change from baseline after 30 days supplementation	Change in Light Sleep in minutes (Weekly averages)
Sustained Attention	Change from baseline after 30 days supplementation	Mean reaction time to stimuli using the psychomotor vigilance test (PVT)
Profile of Mood States (POMS)	Change from baseline after 30 days supplementation	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
Fitbit- Sleep Efficiency	Change from baseline after 30 days supplementation	ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)
Fitbit- Deep Sleep	Change from baseline after 30 days supplementation	Change in Deep Sleep in minutes (Weekly averages)
The Insomnia Severity Index (ISI)	Change from baseline after 30 days supplementation	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.
Pittsburgh Sleep Quality Index (PSQI)	Change from baseline after 30 days supplementation	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.