Trial Outcomes & Findings for Investigational Test of a New Sleep Supplement (NCT NCT03567343)

NCT ID: NCT03567343

Last Updated: 2024-07-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 105 participants
• Primary outcome timeframe: Change from baseline after 30 days supplementation
• Results posted on: 2024-07-18

Participant Flow

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

Participant milestones

Measure	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	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
Overall Study STARTED	53	52
Overall Study COMPLETED	47	49
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Measure	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	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
Overall Study Lost to Follow-up	2	1
Overall Study No longer eligible	2	1
Overall Study Adverse Event	1	0
Overall Study Protocol Violation	1	1

Baseline Characteristics

Investigational Test of a New Sleep Supplement

Baseline characteristics by cohort

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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	Total n=89 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants	46 Participants n=7 Participants	89 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.91 years STANDARD_DEVIATION 7.17 • n=5 Participants	32.85 years STANDARD_DEVIATION 8.62 • n=7 Participants	31.5 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	36 Participants n=7 Participants	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	30 Participants n=5 Participants	25 Participants n=7 Participants	55 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic/Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	43 Participants n=5 Participants	46 Participants n=7 Participants	89 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Sleep Diary- Sleep Latency	-2.1 minutes Interval -5.03 to 0.82	-2.53 minutes Interval -6.3 to 1.24

PRIMARY outcome

Timeframe: 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.

Change in Rapid Eye Movement (REM) Sleep in minutes (Weekly averages)

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Fitbit - Rapid Eye Movement (REM) Sleep	-0.2 minutes Interval -1.96 to 1.56	1.58 minutes Interval -0.77 to 3.94

SECONDARY outcome

Timeframe: 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.

Total Sleep Time in minutes

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Sleep Diary -Total Sleep Time	20.94 minutes Interval 4.19 to 37.69	20.08 minutes Interval -0.64 to 40.8

SECONDARY outcome

Timeframe: 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.

Number of awakenings after sleep onset

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Sleep Diary-Wake After Sleep Onset	-4.48 awakenings Interval -9.37 to 0.41	-3 awakenings Interval -8.1 to 2.1

SECONDARY outcome

Timeframe: 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.

ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Sleep Diary- Sleep Efficiency	2.91 percent Interval 0.49 to 5.32	4.66 percent Interval 1.19 to 8.12

SECONDARY outcome

Timeframe: 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.

Sleep Quality (units on a visual analogue scale from 0-10, 0 being the worst outcome, 10 being the best outcome)

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Sleep Diary - Objective Sleep Quality	0.93 units on a scale Interval 0.59 to 1.28	0.45 units on a scale Interval 0.08 to 0.81

SECONDARY outcome

Timeframe: 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.

Change in Light Sleep in minutes (Weekly averages)

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Fitbit- Light Sleep	-0.03 minutes Interval -3.89 to 3.83	-0.2 minutes Interval -6.23 to 5.82

SECONDARY outcome

Timeframe: 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.

Total sleep time in minutes

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Fitbit - Total Sleep Time	28.5 minutes Interval 9.84 to 47.17	9.84 minutes Interval -15.63 to 35.31

SECONDARY outcome

Timeframe: 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.

ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Fitbit- Sleep Efficiency	-0.03 percent Interval -0.59 to 0.53	-0.11 percent Interval -1.04 to 0.83

SECONDARY outcome

Timeframe: 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.

Change in Deep Sleep in minutes (Weekly averages)

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Fitbit- Deep Sleep	-0.89 minutes Interval -2.26 to 0.47	-0.24 minutes Interval -3.35 to 2.86

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
The Insomnia Severity Index (ISI)	-0.95 score on a scale Interval -2.45 to 0.54	0.96 score on a scale Interval -0.5 to 2.42

SECONDARY outcome

Timeframe: 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.

Attentional lapses (failure to respond to stimuli within 500 ms) using the psychomotor vigilance test (PVT)

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Sustained Attention	-1.69 number of lapses Interval -3.25 to -0.13	0.41 number of lapses Interval -0.88 to 1.71

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Profile of Mood States (POMS) Total Mood Disturbance	0.67 score on a scale Interval -4.92 to 6.25	3.87 score on a scale Interval -1.35 to 9.09
Profile of Mood States (POMS) tension-anxiety	0.05 score on a scale Interval -1.11 to 1.21	1.54 score on a scale Interval 0.4 to 2.69
Profile of Mood States (POMS) depression	0.29 score on a scale Interval -1.55 to 2.12	0.74 score on a scale Interval -0.44 to 1.92
Profile of Mood States (POMS) anger-hostility	1.19 score on a scale Interval -0.05 to 2.43	0.24 score on a scale Interval -0.34 to 0.82
Profile of Mood States (POMS) vigor-activity	1.17 score on a scale Interval -0.92 to 3.25	-0.54 score on a scale Interval -2.61 to 1.53
Profile of Mood States (POMS) fatigue	0.05 score on a scale Interval -1.64 to 1.73	0.48 score on a scale Interval -0.83 to 1.79
Profile of Mood States (POMS) confusion-bewilderment	0.26 score on a scale Interval -0.65 to 1.18	0.33 score on a scale Interval -0.5 to 1.15

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Perceived Stress Scale (PSS)	0.37 score on a scale Interval -1.48 to 2.22	1.39 score on a scale Interval -0.65 to 3.43

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
The Center for Epidemiological Studies Depression Scale (CESD)	0.51 score on a scale Interval -1.69 to 2.72	0.63 score on a scale Interval -0.9 to 2.16

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Pittsburgh Sleep Quality Index (PSQI)	-0.23 score on a scale Interval -1.05 to 0.58	0.11 score on a scale Interval -0.77 to 0.99

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Proprietary Spearmint Extract Blend n=43 Participants 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	Control n=46 Participants 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
Sustained Attention	-43.09 milliseconds Interval -98.43 to 12.26	-2.01 milliseconds Interval -20.13 to 16.11

Adverse Events

Proprietary Spearmint Extract Blend

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Proprietary Spearmint Extract Blend n=53 participants at risk 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	Control n=52 participants at risk 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
Gastrointestinal disorders Stomach Discomfort	0.00% 0/53 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.	5.8% 3/52 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.
Musculoskeletal and connective tissue disorders Muscle pain	3.8% 2/53 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.	5.8% 3/52 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.
General disorders Headache/migraine	3.8% 2/53 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.	1.9% 1/52 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.
General disorders Sore throat	3.8% 2/53 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.	1.9% 1/52 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.
General disorders Tooth pain	0.00% 0/53 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.	1.9% 1/52 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.
General disorders Ear ache	1.9% 1/53 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.	0.00% 0/52 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.
General disorders Sinus congestion	1.9% 1/53 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.	1.9% 1/52 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.
General disorders Fever	1.9% 1/53 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.	0.00% 0/52 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.
General disorders Fatigue	1.9% 1/53 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.	0.00% 0/52 • 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. Any events of discomfort, pain, or abnormalities occurring during the course of the study.

Additional Information

Dr Michael Grandner

The University of Arizona

Phone: 15206266346

Email: grandner@email.arizona.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place