Investigational Test of a New Sleep Supplement | NCT03567343

NCT03567343

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Kemin Foods LC	INDUSTRY

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Proprietary Spearmint Extract Blend	Active Comparator	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
Control	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Proprietary Spearmint Extract Blend	Dietary Supplement	Water extracted spearmint extract and green tea blend	Proprietary Spearmint Extract Blend

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	Change in Rapid Eye Movement (REM) Sleep in minutes (Weekly averages)	Change from baseline after 30 days supplementation

Measure	Description	Time Frame
Sleep Diary -Total Sleep Time	Total Sleep Time in minutes	Change from baseline after 30 days supplementation
Sleep Diary-Wake After Sleep Onset	Number of awakenings after sleep onset

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Michael Grandner, PhD	University of Arizona	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona Dept of Psychiatry Research facilities		Tucson	Arizona	85724	United States

PubMed Identifier	Type	Citation	Retractions
33809544	Derived	Tubbs AS, Kennedy KER, Alfonso-Miller P, Wills CCA, Grandner MA. A Randomized, Double-Blind, Placebo-Controlled Trial of a Polyphenol Botanical Blend on Sleep and Daytime Functioning. Int J Environ Res Public Health. 2021 Mar 16;18(6):3044. doi: 10.3390/ijerph18063044.

Arm/Group Information

ID	Title	Description
FG000	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 Proprietary Spearmint Extract Blend: Water extracted spearmint extract and green tea blend
FG001	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 Control: Placebo

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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 Proprietary Spearmint Extract Blend: Water extracted spearmint extract and green tea blend

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Sleep Diary- Sleep Latency

Time it takes to fall asleep after the lights have been turned off in minutes (Weekly averages)

Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.

Posted

Mean

95% Confidence Interval

minutes

Change from baseline after 30 days supplementation

ID	Title	Description
OG000	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 Proprietary Spearmint Extract Blend: Water extracted spearmint extract and green tea blend

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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 Proprietary Spearmint Extract Blend: Water extracted spearmint extract and green tea blend