Investigational Test of a New Sleep Supplement

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of a Proprietary Spearmint Extract Blend, on Sleep in Healthy Men and Women

Conditions
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Sleep, Mood, Cognitive Performance

Intervention / Treatment
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* Dietary Supplement: Proprietary Spearmint Extract Blend
* Other: Control
* Dietary Supplement: Proprietary Blend And Melatonin
* Dietary Supplement: Melatonin


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA To be included in the study, patients must: Subject is a male or female, 22-50 years of age, inclusive. Subject is judged by the Investigator to be in general good health on the basis of medical history. Subject is a non-user of nicotine products for 6 months prior to screening. Subject's initial online screen reveals a score >5 on the PSQI. Subject has a BMI of 18.50-29.99 kg/m2, inclusive, at screening. Subject is willing to maintain habitual diet and activity patterns throughout the study period, other than the study instructions given for caffeine, alcohol, and vigorous physical activity. Subject is willing to consume study product 30 minutes before bed throughout the study period. Subject will consume no more than 14 alcoholic drinks (12oz beer, 5oz wine, 1.5oz distilled spirits) per week while in the study, no more than 4 drinks on a single occasion, and no more than 1 alcoholic drink within 4 hours of bedtime. Subject will consume no more than 4 servings of caffeine substances per day (8oz coffee, 1oz espresso, 12oz caffeinated soda, 8oz energy drink) and no caffeine within 6 hours of bedtime. Subject will refrain from vigorous physical activity (causing sweating) within 2 hours of bedtime. Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator. EXCLUSION CRITERIA Subject has a history or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, chronic pain condition(s), or neurologic disorders. Subject has a history of diagnosed clinical depression in the prior 2 years of screening. This will be determined by self report at screening (PHQ9 scores indicating likely depression diagnosis (<=2 on items 1 or 2, plus <=2 on at least 5 other symptoms) will be exclusionary) and with the Mini International Neuropsychiatric Inventory assessed at the screening visit. Subject has an active infection or signs/symptoms of an infection. Clinic visits and/or sleep evaluations will be rescheduled to allow subject to be symptom-free of any type of systemic infection for at least 5 days. Subject has uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg) at screening. Subject has a known allergy or sensitivity to any ingredients in the study products. Subject is a heavy consumer of caffeinated beverages (>400 mg caffeine/d from caffeine-containing products) within 2 weeks of screening. Subject diagnosed with a psychiatric disorder that would impair their ability to perform the study, such as a psychotic disorder, bipolar disorder, neurodevelopmental disorder, post-traumatic stress disorder, etc. The subject should not currently be experiencing a major depressive episode. Psychiatric history will be assessed at screening then reassessed at the screening visit; In addition, the Mini International Neuropsychiatric Inventory will be conducted at the screening visit. Subject has a history of use of psychotropic medications (including antidepressants, beta-blockers, and tranquilizers), stimulant medications, medical marijuana and/or narcotics within 4 weeks of screening. Subject has used sleep aid medications, supplements, and/or products (over-the-counter or prescription), including antihistamines, within 2 weeks of screening. If use has occurred a wash-out period can be conducted. Subject has a history of unconventional sleep patterns (e.g., night shift), chronic insomnia (defined as insomnia at least 3 d/week over the past month), a diagnosed sleep disorder (e.g., OSA), or a chronic medical condition that may impact energy/fatigue levels, in the judgment of the Investigator. Subject has a history of cancer within 5 years prior to screening except for non-melanoma skin cancer. Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to use of a medically approved form of contraception throughout the study period. Subject has a current or recent history (past 12 months of screening) or strong potential for drug or alcohol abuse. Alcohol abuse will be defined as > 14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 1.5 oz. hard liquor). Subject has been exposed to any non-registered drug product within 30 d prior to screening. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, might confound the interpretation of the study results, or put the person at undue risk.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Proprietary Spearmint Extract Blend<br>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 | Dietary Supplement: Proprietary Spearmint Extract Blend<br>* Water extracted spearmint extract and green tea blend<br>|
| Placebo Comparator: Control<br>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 | Other: Control<br>* Placebo<br>|
| Active Comparator: Proprietary Blend And Melatonin<br>Subjects randomized into the active treatment group will be asked to consume 500 mg/day of the proprietary spearmint extract blend and 1 Mg of melatonin 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. | Dietary Supplement: Proprietary Blend And Melatonin<br>* Water extracted spearmint extract and green tea blend and Melatonin (Proprietary Spearmint Extract Blend and Melatonin)<br>|
| Active Comparator: Melatonin<br>Subjects randomized into the active treatment group will be asked to consume 1 Mg of melatonin by mouth every night 30 mins before bed and complete a sleep diary upon waking and wear a Fitbit Charge 2 device for sleep monitoring for 30 days. | Dietary Supplement: Melatonin<br>* Melatonin Alone<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Diary -Total Sleep Time | Total Sleep Time in hours | Change from baseline after 30 days supplementation | 
| Sleep diary-Wake After Sleep Onset | Number of awakenings after sleep onset | 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) | Change from baseline after 30 days supplementation | 
| Sleep Diary - Objective Sleep Quality | Sleep Quality (units on a visual analogue scale from 0-10) | Change from baseline after 30 days supplementation | 
| Fitbit- %Light Sleep | %Light Sleep in minutes (Weekly averages) | Change from baseline after 30 days supplementation | 
| Fitbit - total sleep time | Total sleep time in hours | 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) | Change from baseline after 30 days supplementation | 
| Fitbit- %Deep Sleep | %Deep Sleep in minutes (Weekly averages) | 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. | Change from baseline after 30 days supplementation | 
| Sustained Attention | Attentional lapses, mean reaction time, median reaction time using the psychomotor vigilance test (PVT) | 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) | 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. | 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. | 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. | Change from baseline after 30 days supplementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep