Cognitive Performance, Mood, Sleep
Conditions
Keywords
sleep
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.
Interventions
DIETARY_SUPPLEMENTProprietary Spearmint Extract Blend
Water extracted spearmint extract and green tea blend
OTHERControl
Placebo
Sponsors
Kemin Foods LC
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
To be included in the study, patients must: 1. Subject is a male or female, 22-50 years of age, inclusive. 2. Subject is judged by the Investigator to be in general good health on the basis of medical history. 3. Subject is a non-user of nicotine products for 6 months prior to screening. 4. Subject's initial online screen reveals a score \>5 on the PSQI. 5. Subject has a BMI of 18.50-29.99 kg/m2, inclusive, at screening. 6. 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. 7. Subject is willing to consume study product 30 minutes before bed throughout the study period. 8. 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. 9. 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. 10. Subject will refrain from vigorous physical activity (causing sweating) within 2 hours of bedtime. 11. 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
1. Subject has a history or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, chronic pain condition(s), or neurologic disorders. 2. 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. 3. 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. 4. Subject has uncontrolled hypertension (systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg) at screening. 5. Subject has a known allergy or sensitivity to any ingredients in the study products. 6. Subject is a heavy consumer of caffeinated beverages (\>400 mg caffeine/d from caffeine-containing products) within 2 weeks of screening. 7. 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. 8. 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. 9. 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. 10. 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. 11. Subject has a history of cancer within 5 years prior to screening except for non-melanoma skin cancer. 12. 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. 13. 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). 14. Subject has been exposed to any non-registered drug product within 30 d prior to screening. 15. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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- Light Sleep | Change from baseline after 30 days supplementation | Change in Light Sleep in minutes (Weekly averages) |
| Fitbit - Total Sleep Time | Change from baseline after 30 days supplementation | Total sleep time in minutes |
| 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) |
| Sleep Diary-Wake After Sleep Onset | Change from baseline after 30 days supplementation | Number of awakenings after sleep onset |
| Sustained Attention | Change from baseline after 30 days supplementation | Attentional lapses (failure to respond to stimuli within 500 ms) 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 |
| 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. |
| 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. |
| 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. |
| Sleep Diary -Total Sleep Time | Change from baseline after 30 days supplementation | Total Sleep Time in minutes |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred by self-referral, social media, and flyer advertising in Tucson, Arizona, USA.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 43 |
| 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 | 46 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | No longer eligible | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Proprietary Spearmint Extract Blend | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 46 Participants | 89 Participants |
| Age, Continuous | 29.91 years STANDARD_DEVIATION 7.17 | 32.85 years STANDARD_DEVIATION 8.62 | 31.5 years STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 10 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 36 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 8 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Hispanic/Latino | 10 Participants | 10 Participants | 20 Participants |
| Race/Ethnicity, Customized Race White | 30 Participants | 25 Participants | 55 Participants |
| Region of Enrollment United States | 43 Participants | 46 Participants | 89 Participants |
| Sex: Female, Male Female | 26 Participants | 28 Participants | 54 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 52 |
| other Total, other adverse events | 6 / 53 | 9 / 52 |
| serious Total, serious adverse events | 0 / 53 | 0 / 52 |
Outcome results
Primary
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
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | Fitbit - Rapid Eye Movement (REM) Sleep | -0.2 minutes |
| Control | Fitbit - Rapid Eye Movement (REM) Sleep | 1.58 minutes |
p-value: 0.816595% CI: [-1.96, 1.56]Paired T-test
p-value: 0.182195% CI: [-0.77, 3.94]Paired T-test
Primary
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
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | Sleep Diary- Sleep Latency | -2.1 minutes |
| Control | Sleep Diary- Sleep Latency | -2.53 minutes |
p-value: 0.154395% CI: [-5.03, 0.82]Paired T-test
p-value: 0.182795% CI: [-6.3, 1.24]Paired T-test
Secondary
Fitbit- Deep Sleep
Change in Deep Sleep in minutes (Weekly averages)
Time frame: Change from baseline after 30 days supplementation
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | Fitbit- Deep Sleep | -0.89 minutes |
| Control | Fitbit- Deep Sleep | -0.24 minutes |
p-value: 0.192995% CI: [-2.26, 0.47]Paired T-test
p-value: 0.874495% CI: [-3.35, 2.86]Paired T-test
Secondary
Fitbit- Light Sleep
Change in Light Sleep in minutes (Weekly averages)
Time frame: Change from baseline after 30 days supplementation
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | Fitbit- Light Sleep | -0.03 minutes |
| Control | Fitbit- Light Sleep | -0.2 minutes |
p-value: 0.987595% CI: [-3.89, 3.83]Paired T-test
p-value: 0.946395% CI: [-6.23, 5.82]Paired T-test
Secondary
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
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | Fitbit- Sleep Efficiency | -0.03 percent |
| Control | Fitbit- Sleep Efficiency | -0.11 percent |
p-value: 0.91295% CI: [-0.59, 0.53]Paired T-test
p-value: 0.820795% CI: [-1.04, 0.83]Paired T-test
Secondary
Fitbit - Total Sleep Time
Total sleep time in minutes
Time frame: Change from baseline after 30 days supplementation
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | Fitbit - Total Sleep Time | 28.5 minutes |
| Control | Fitbit - Total Sleep Time | 9.84 minutes |
p-value: 0.003795% CI: [9.84, 47.17]Paired T-test
p-value: 0.439595% CI: [-15.63, 35.31]Paired T-test
Secondary
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
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | Perceived Stress Scale (PSS) | 0.37 score on a scale |
| Control | Perceived Stress Scale (PSS) | 1.39 score on a scale |
p-value: 0.686995% CI: [-1.48, 2.22]Paired T-test
p-value: 0.176995% CI: [-0.65, 3.43]Paired T-test
Secondary
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
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | Pittsburgh Sleep Quality Index (PSQI) | -0.23 score on a scale |
| Control | Pittsburgh Sleep Quality Index (PSQI) | 0.11 score on a scale |
p-value: 0.567295% CI: [-1.05, 0.58]Paired T-test
p-value: 0.80595% CI: [-0.77, 0.99]Paired T-test
Secondary
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
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Proprietary Spearmint Extract Blend | Profile of Mood States (POMS) | depression | 0.29 score on a scale |
| Proprietary Spearmint Extract Blend | Profile of Mood States (POMS) | vigor-activity | 1.17 score on a scale |
| Proprietary Spearmint Extract Blend | Profile of Mood States (POMS) | tension-anxiety | 0.05 score on a scale |
| Proprietary Spearmint Extract Blend | Profile of Mood States (POMS) | fatigue | 0.05 score on a scale |
| Proprietary Spearmint Extract Blend | Profile of Mood States (POMS) | anger-hostility | 1.19 score on a scale |
| Proprietary Spearmint Extract Blend | Profile of Mood States (POMS) | confusion-bewilderment | 0.26 score on a scale |
| Proprietary Spearmint Extract Blend | Profile of Mood States (POMS) | Total Mood Disturbance | 0.67 score on a scale |
| Control | Profile of Mood States (POMS) | confusion-bewilderment | 0.33 score on a scale |
| Control | Profile of Mood States (POMS) | Total Mood Disturbance | 3.87 score on a scale |
| Control | Profile of Mood States (POMS) | tension-anxiety | 1.54 score on a scale |
| Control | Profile of Mood States (POMS) | depression | 0.74 score on a scale |
| Control | Profile of Mood States (POMS) | anger-hostility | 0.24 score on a scale |
| Control | Profile of Mood States (POMS) | vigor-activity | -0.54 score on a scale |
| Control | Profile of Mood States (POMS) | fatigue | 0.48 score on a scale |
Comparison: POMS-TMDp-value: 0.810695% CI: [-4.92, 6.25]Paired T-test
Comparison: POMS-TMDp-value: 0.142795% CI: [-1.35, 9.09]Paired T-test
Comparison: POMS-Tensionp-value: 0.934495% CI: [-1.11, 1.21]Paired T-test
Comparison: POMS-Tensionp-value: 0.009295% CI: [0.4, 2.69]Paired T-test
Comparison: POMS-Depressionp-value: 0.75595% CI: [-1.55, 2.12]Paired T-test
Comparison: POMS-Depressionp-value: 0.213195% CI: [-0.44, 1.92]Paired T-test
Comparison: POMS-Angerp-value: 0.0695% CI: [-0.05, 2.43]Paired T-test
Comparison: POMS-Angerp-value: 0.411795% CI: [-0.34, 0.82]Paired T-test
Comparison: POMS-Fatiguep-value: 0.954895% CI: [-1.64, 1.73]Paired T-test
Comparison: POMS-Fatiguep-value: 0.464995% CI: [-0.83, 1.79]Paired T-test
Comparison: POMS-Confusionp-value: 0.565695% CI: [-0.65, 1.18]Paired T-test
Comparison: POMS-Confusionp-value: 0.430795% CI: [-0.5, 1.15]Paired T-test
Comparison: POMS-Vigorp-value: 0.265195% CI: [-0.92, 3.25]Paired T-test
Comparison: POMS-Vigorp-value: 0.599295% CI: [-2.61, 1.53]Paired T-test
Secondary
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
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | Sleep Diary - Objective Sleep Quality | 0.93 units on a scale |
| Control | Sleep Diary - Objective Sleep Quality | 0.45 units on a scale |
p-value: <0.000195% CI: [0.59, 1.28]Paired T-test
p-value: 0.017995% CI: [0.08, 0.81]Paired T-test
Secondary
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
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | Sleep Diary- Sleep Efficiency | 2.91 percent |
| Control | Sleep Diary- Sleep Efficiency | 4.66 percent |
p-value: 0.019595% CI: [0.49, 5.32]Paired T-test
p-value: 0.009795% CI: [1.19, 8.12]Paired T-test
Secondary
Sleep Diary -Total Sleep Time
Total Sleep Time in minutes
Time frame: Change from baseline after 30 days supplementation
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | Sleep Diary -Total Sleep Time | 20.94 minutes |
| Control | Sleep Diary -Total Sleep Time | 20.08 minutes |
p-value: 0.015695% CI: [4.19, 37.69]Paired T-test
p-value: 0.057295% CI: [-0.64, 40.8]Paired T-test
Secondary
Sleep Diary-Wake After Sleep Onset
Number of awakenings after sleep onset
Time frame: Change from baseline after 30 days supplementation
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | Sleep Diary-Wake After Sleep Onset | -4.48 awakenings |
| Control | Sleep Diary-Wake After Sleep Onset | -3 awakenings |
p-value: 0.078195% CI: [-9.37, 0.41]Paired T-test
p-value: 0.24295% CI: [-8.1, 2.1]Paired T-test
Secondary
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
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | Sustained Attention | -1.69 number of lapses |
| Control | Sustained Attention | 0.41 number of lapses |
Comparison: change in mean number of lapsesp-value: 0.03495% CI: [-3.25, -0.13]Paired T-test
Comparison: Change in number of lapsesp-value: 0.524295% CI: [-0.88, 1.71]Paired T-test
Secondary
Sustained Attention
Mean reaction time to stimuli using the psychomotor vigilance test (PVT)
Time frame: Change from baseline after 30 days supplementation
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | Sustained Attention | -43.09 milliseconds |
| Control | Sustained Attention | -2.01 milliseconds |
Comparison: Change in lapse timep-value: 0.123695% CI: [-98.43, 12.26]Paired T-test
Comparison: Change in lapse timep-value: 0.824195% CI: [-20.13, 16.11]Paired T-test
Secondary
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
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | The Center for Epidemiological Studies Depression Scale (CESD) | 0.51 score on a scale |
| Control | The Center for Epidemiological Studies Depression Scale (CESD) | 0.63 score on a scale |
p-value: 0.642295% CI: [-1.69, 2.72]Paired T-test
p-value: 0.410695% CI: [-0.9, 2.16]Paired T-test
Secondary
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
Population: Final analyses included only 43 participants (4 excluded) in the active group, and 46 participants (3 excluded), due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proprietary Spearmint Extract Blend | The Insomnia Severity Index (ISI) | -0.95 score on a scale |
| Control | The Insomnia Severity Index (ISI) | 0.96 score on a scale |
p-value: 0.204895% CI: [-2.45, 0.54]Paired T-test
p-value: 0.193395% CI: [-0.5, 2.42]Paired T-test