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CompletedNCT03567343InTeNSSUpdated Jul 18, 2024Results posted

Investigational Test of a New Sleep Supplement

An interventional study of Proprietary Spearmint Extract Blend and Control in Sleep, Mood and Cognitive Performance, sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 22 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-18.

Sponsored by University of Arizona · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
22 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sleep
  • Mood
  • Cognitive Performance

Keywords

  • sleep
03

In context

Lead sponsor

University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 50 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
105 participants (actual)

Study arms

  • Active comparator
    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

    Dietary Supplement: Proprietary Spearmint Extract Blend

  • Placebo comparator
    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

    Other: Control

Interventions

  • Dietary supplementProprietary Spearmint Extract Blend

    Water extracted spearmint extract and green tea blend

  • OtherControl

    Placebo

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Sleep Diary -Total Sleep Time

    Total Sleep Time in minutes

    Time frame: Change from baseline after 30 days supplementation

  2. Sleep Diary-Wake After Sleep Onset

    Number of awakenings after sleep onset

    Time frame: Change from baseline after 30 days supplementation

  3. 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

  4. 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

  5. Fitbit- Light Sleep

    Change in Light Sleep in minutes (Weekly averages)

    Time frame: Change from baseline after 30 days supplementation

  6. Fitbit - Total Sleep Time

    Total sleep time in minutes

    Time frame: Change from baseline after 30 days supplementation

  7. 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

  8. Fitbit- Deep Sleep

    Change in Deep Sleep in minutes (Weekly averages)

    Time frame: Change from baseline after 30 days supplementation

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. Sustained Attention

    Mean reaction time to stimuli using the psychomotor vigilance test (PVT)

    Time frame: Change from baseline after 30 days supplementation

07

Results

Posted Jul 18, 2024
Limitations and caveats
Models were not adjusted for baseline differences in race/ethnicity and REM sleep. Also, there is a lack of polysomnography data, which is the gold standard for evaluating sleep architecture, severely limits inferences on the effects of PBB on REM sleep. A further limitation is that neurocognitive testing was not conducted at a consistent time of day across individuals, meaning the results of neurocognitive testing could have been influenced by time-of-day testing effects.

Participant flow

Recruitment occurred by self-referral, social media, and flyer advertising in Tucson, Arizona, USA.

Participant flow — Overall Study
MilestoneProprietary Spearmint Extract BlendControl
Started5352
Completed4749
Not completed63
Withdrew: Lost to follow-up21
Withdrew: No longer eligible21
Withdrew: Adverse event10
Withdrew: Protocol violation11

Outcome measures

PrimarySleep 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
Reported as:
Mean · minutes
Sleep Diary- Sleep Latency
minutesProprietary Spearmint Extract BlendControl
Sleep Diary- Sleep Latency-2.1 (-5.03 to .82)-2.53 (-6.3 to 1.24)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.1543 (The threshold for statistical significance was P\< 0.05.) · Mean difference (net): -2.1 · 95% CI -5.03 to 0.82
  • Control · Paired T-test · p = 0.1827 · Mean difference (net): -2.53 · 95% CI -6.3 to 1.24
PrimaryFitbit - 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
Reported as:
Mean · minutes
Fitbit - Rapid Eye Movement (REM) Sleep
minutesProprietary Spearmint Extract BlendControl
Fitbit - Rapid Eye Movement (REM) Sleep-0.2 (-1.96 to 1.56)1.58 (-0.77 to 3.94)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.8165 · Mean difference (net): -0.2 · 95% CI -1.96 to 1.56
  • Control · Paired T-test · p = 0.1821 · Mean difference (net): 1.58 · 95% CI -0.77 to 3.94
SecondarySleep Diary -Total Sleep Time

Total Sleep Time in minutes

Time frame:
Change from baseline after 30 days supplementation
Reported as:
Mean · minutes
Sleep Diary -Total Sleep Time
minutesProprietary Spearmint Extract BlendControl
Sleep Diary -Total Sleep Time20.94 (4.19 to 37.69)20.08 (-0.64 to 40.8)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.0156 · Mean difference (net): 20.94 · 95% CI 4.19 to 37.69
  • Control · Paired T-test · p = 0.0572 · Mean difference (net): 20.08 · 95% CI -0.64 to 40.8
SecondarySleep Diary-Wake After Sleep Onset

Number of awakenings after sleep onset

Time frame:
Change from baseline after 30 days supplementation
Reported as:
Mean · awakenings
Sleep Diary-Wake After Sleep Onset
awakeningsProprietary Spearmint Extract BlendControl
Sleep Diary-Wake After Sleep Onset-4.48 (-9.37 to 0.41)-3 (-8.1 to 2.1)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.0781 · Mean difference (net): -4.48 · 95% CI -9.37 to 0.41
  • Control · Paired T-test · p = 0.242 · Mean difference (net): -3.0 · 95% CI -8.1 to 2.1
SecondarySleep 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
Reported as:
Mean · percent
Sleep Diary- Sleep Efficiency
percentProprietary Spearmint Extract BlendControl
Sleep Diary- Sleep Efficiency2.91 (0.49 to 5.32)4.66 (1.19 to 8.12)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.0195 · Mean difference (net): 2.91 · 95% CI 0.49 to 5.32
  • Control · Paired T-test · p = 0.0097 · Mean difference (net): 4.66 · 95% CI 1.19 to 8.12
SecondarySleep 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
Reported as:
Mean · units on a scale
Sleep Diary - Objective Sleep Quality
units on a scaleProprietary Spearmint Extract BlendControl
Sleep Diary - Objective Sleep Quality0.93 (0.59 to 1.28)0.45 (0.08 to 0.81)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = <0.0001 · Mean difference (net): 0.93 · 95% CI 0.59 to 1.28
  • Control · Paired T-test · p = 0.0179 · Mean difference (net): 0.45 · 95% CI 0.08 to 0.81
SecondaryFitbit- Light Sleep

Change in Light Sleep in minutes (Weekly averages)

Time frame:
Change from baseline after 30 days supplementation
Reported as:
Mean · minutes
Fitbit- Light Sleep
minutesProprietary Spearmint Extract BlendControl
Fitbit- Light Sleep-0.03 (-3.89 to 3.83)-0.2 (-6.23 to 5.82)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.9875 · Mean difference (net): -0.03 · 95% CI -3.89 to 3.83
  • Control · Paired T-test · p = 0.9463 · Mean difference (net): -0.2 · 95% CI -6.23 to 5.82
SecondaryFitbit - Total Sleep Time

Total sleep time in minutes

Time frame:
Change from baseline after 30 days supplementation
Reported as:
Mean · minutes
Fitbit - Total Sleep Time
minutesProprietary Spearmint Extract BlendControl
Fitbit - Total Sleep Time28.5 (9.84 to 47.17)9.84 (-15.63 to 35.31)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.0037 · Mean difference (net): 28.5 · 95% CI 9.84 to 47.17
  • Control · Paired T-test · p = 0.4395 · Mean difference (net): 9.84 · 95% CI -15.63 to 35.31
SecondaryFitbit- 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
Reported as:
Mean · percent
Fitbit- Sleep Efficiency
percentProprietary Spearmint Extract BlendControl
Fitbit- Sleep Efficiency-0.03 (-0.59 to 0.53)-0.11 (-1.04 to 0.83)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.912 · Mean difference (net): -0.03 · 95% CI -0.59 to 0.53
  • Control · Paired T-test · p = .8207 · Mean difference (net): -0.11 · 95% CI -1.04 to 0.83
SecondaryFitbit- Deep Sleep

Change in Deep Sleep in minutes (Weekly averages)

Time frame:
Change from baseline after 30 days supplementation
Reported as:
Mean · minutes
Fitbit- Deep Sleep
minutesProprietary Spearmint Extract BlendControl
Fitbit- Deep Sleep-0.89 (-2.26 to 0.47)-0.24 (-3.35 to 2.86)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.1929 · Mean difference (net): -0.89 · 95% CI -2.26 to 0.47
  • Control · Paired T-test · p = 0.8744 · Mean difference (net): -.24 · 95% CI -3.35 to 2.86
SecondaryThe 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
Reported as:
Mean · score on a scale
The Insomnia Severity Index (ISI)
score on a scaleProprietary Spearmint Extract BlendControl
The Insomnia Severity Index (ISI)-0.95 (-2.45 to 0.54)0.96 (-0.5 to 2.42)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.2048 · Mean difference (net): -.95 · 95% CI -2.45 to 0.54
  • Control · Paired T-test · p = 0.1933 · Mean difference (net): 0.96 · 95% CI -0.5 to 2.42
SecondarySustained 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
Reported as:
Mean · number of lapses
Sustained Attention
number of lapsesProprietary Spearmint Extract BlendControl
Sustained Attention-1.69 (-3.25 to -0.13)0.41 (-0.88 to 1.71)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.034 · Mean difference (net): -1.69 · 95% CI -3.25 to -0.13
  • Control · Paired T-test · p = 0.5242 · Mean difference (net): 0.41 · 95% CI -0.88 to 1.71
SecondaryProfile 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
Reported as:
Mean · score on a scale
Profile of Mood States (POMS)
score on a scaleProprietary Spearmint Extract BlendControl
Total Mood Disturbance0.67 (-4.92 to 6.25)3.87 (-1.35 to 9.09)
tension-anxiety0.05 (-1.11 to 1.21)1.54 (0.4 to 2.69)
depression0.29 (-1.55 to 2.12)0.74 (-0.44 to 1.92)
anger-hostility1.19 (-0.05 to 2.43)0.24 (-0.34 to 0.82)
vigor-activity1.17 (-0.92 to 3.25)-0.54 (-2.61 to 1.53)
fatigue0.05 (-1.64 to 1.73)0.48 (-0.83 to 1.79)
confusion-bewilderment0.26 (-0.65 to 1.18)0.33 (-0.5 to 1.15)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.8106 · Mean difference (net): 0.67 · 95% CI -4.92 to 6.25
  • Control · Paired T-test · p = 0.1427 · Mean difference (net): 3.87 · 95% CI -1.35 to 9.09
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.9344 · Mean difference (net): 0.05 · 95% CI -1.11 to 1.21
  • Control · Paired T-test · p = 0.0092 · Mean difference (net): 1.54 · 95% CI 0.40 to 2.69
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.755 · Mean difference (net): 0.29 · 95% CI -1.55 to 2.12
  • Control · Paired T-test · p = 0.2131 · Mean difference (net): 0.74 · 95% CI -0.44 to 1.92
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.06 · Mean difference (net): 1.19 · 95% CI -0.05 to 2.43
  • Control · Paired T-test · p = 0.4117 · Mean difference (net): 0.24 · 95% CI -0.34 to 0.82
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.9548 · Mean difference (net): 0.05 · 95% CI -1.64 to 1.73
  • Control · Paired T-test · p = 0.4649 · Mean difference (net): 0.48 · 95% CI -0.83 to 1.79
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.5656 · Mean difference (net): 0.26 · 95% CI -0.65 to 1.18
  • Control · Paired T-test · p = 0.4307 · Mean difference (net): 0.33 · 95% CI -0.5 to 1.15
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.2651 · Mean difference (net): 1.17 · 95% CI -0.92 to 3.25
  • Control · Paired T-test · p = 0.5992 · Mean difference (net): -0.54 · 95% CI -2.61 to 1.53
SecondaryPerceived 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
Reported as:
Mean · score on a scale
Perceived Stress Scale (PSS)
score on a scaleProprietary Spearmint Extract BlendControl
Perceived Stress Scale (PSS)0.37 (-1.48 to 2.22)1.39 (-0.65 to 3.43)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.6869 · Mean difference (net): 0.37 · 95% CI -1.48 to 2.22
  • Control · Paired T-test · p = 0.1769 · Mean difference (net): 1.39 · 95% CI -0.65 to 3.43
SecondaryThe 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
Reported as:
Mean · score on a scale
The Center for Epidemiological Studies Depression Scale (CESD)
score on a scaleProprietary Spearmint Extract BlendControl
The Center for Epidemiological Studies Depression Scale (CESD)0.51 (-1.69 to 2.72)0.63 (-0.9 to 2.16)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.6422 · Mean difference (net): 0.51 · 95% CI -1.69 to 2.72
  • Control · Paired T-test · p = 0.4106 · Mean difference (net): 0.63 · 95% CI -0.9 to 2.16
SecondaryPittsburgh 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
Reported as:
Mean · score on a scale
Pittsburgh Sleep Quality Index (PSQI)
score on a scaleProprietary Spearmint Extract BlendControl
Pittsburgh Sleep Quality Index (PSQI)-0.23 (-1.05 to 0.58)0.11 (-0.77 to 0.99)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = 0.5672 · Mean difference (net): -0.23 · 95% CI -1.05 to 0.58
  • Control · Paired T-test · p = 0.805 · Mean difference (net): 0.11 · 95% CI -0.77 to 0.99
SecondarySustained Attention

Mean reaction time to stimuli using the psychomotor vigilance test (PVT)

Time frame:
Change from baseline after 30 days supplementation
Reported as:
Mean · milliseconds
Sustained Attention
millisecondsProprietary Spearmint Extract BlendControl
Sustained Attention-43.09 (-98.43 to 12.26)-2.01 (-20.13 to 16.11)
Statistical analysis
  • Proprietary Spearmint Extract Blend · Paired T-test · p = .1236 · Median difference (net): -43.09 · 95% CI -98.43 to 12.26
  • Control · Paired T-test · p = .8241 · Mean difference (net): -2.01 · 95% CI -20.13 to 16.11

Adverse events

Collected over Adverse event data were collected for approximately 1 month for each participant, as the duration of participation for any given participant was approximately 1 month.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Proprietary Spearmint Extract Blend0/53 (0%)0/53 (0%)6/53 (11.3%)
Control0/52 (0%)0/52 (0%)9/52 (17.3%)
Most frequent other events
Most frequent other events
EventProprietary Spearmint Extract BlendControl
Stomach DiscomfortGastrointestinal disorders0/533/52
Muscle painMusculoskeletal and connective tissue disorders2/533/52
Headache/migraineGeneral disorders2/531/52
Sore throatGeneral disorders2/531/52
Tooth painGeneral disorders0/531/52
Sinus congestionGeneral disorders1/531/52
Ear acheGeneral disorders1/530/52
FeverGeneral disorders1/530/52
FatigueGeneral disorders1/530/52

Baseline characteristics

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

Age, Categorical
Age, Categorical(Participants)Proprietary Spearmint Extract BlendControlTotal
<=18 years000
Between 18 and 65 years434689
>=65 years000
Age, Continuous
Age, Continuous(years)Proprietary Spearmint Extract BlendControlTotal
Mean29.91 ± 7.1732.85 ± 8.6231.5 ± 8.1
Sex: Female, Male
Sex: Female, Male(Participants)Proprietary Spearmint Extract BlendControlTotal
Female262854
Male171835
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Proprietary Spearmint Extract BlendControlTotal
Hispanic or Latino101020
Not Hispanic or Latino333669
Unknown or Not Reported000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Proprietary Spearmint Extract BlendControlTotal
Race — American Indian or Alaska Native101
Race — Asian088
Race — Black or African American235
Race — White302555
Race — Hispanic/Latino101020
Region of Enrollment
Region of Enrollment(Participants)Proprietary Spearmint Extract BlendControlTotal
United States434689
08

Study locations

1 site
  • University of Arizona Dept of Psychiatry Research facilities
    Tucson, Arizona 85724, United States
09

References and documents

Publications

  • 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. PubMed 33809544 ↗

Study documents

  • Study protocol · May 16, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03567343
Lead sponsor
University of Arizona
Collaborators
Kemin Foods LC
Responsible party
MICHAEL A GRANDNER (Assistant Professor of Psychiatry, Psychology, and Medicine Director, Sleep & Health Research Program, University of Arizona) — Principal investigator
First posted
Jun 25, 2018
Start date
May 18, 2018
Primary completion
Oct 15, 2019
Completion
Oct 15, 2019
Results posted
Jul 18, 2024
Last update
Jul 18, 2024

Study contacts

Michael Grandner, PhD
principal investigator · University of Arizona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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