Investigational Test of a New Sleep Supplement

NCT03567343 | Completed Results

• 1 other identifier: 1803377507
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Mood; Cognitive Performance

Keywords

sleep

Outcome Measures

Primary Outcomes (2)

• Sleep Diary- Sleep Latency

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

  Change from baseline after 30 days supplementation

• Fitbit - Rapid Eye Movement (REM) Sleep

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

  Change from baseline after 30 days supplementation

Secondary Outcomes (15)

• Sleep Diary -Total Sleep Time

  Change from baseline after 30 days supplementation

• Sleep Diary-Wake After Sleep Onset

  Change from baseline after 30 days supplementation

• Sleep Diary- Sleep Efficiency

  Change from baseline after 30 days supplementation

• Sleep Diary - Objective Sleep Quality

  Change from baseline after 30 days supplementation

• Fitbit- Light Sleep

  Change from baseline after 30 days supplementation

Study Arms (2)

Proprietary Spearmint Extract Blend

ACTIVE COMPARATOR

Subjects randomized into the active treatment group will be asked to consume 500 mg/day of the Proprietary Spearmint Extract Blend blend by mouth every night 30 mins before bed, complete a sleep diary upon waking and wear a Fitbit Charge 2 device for sleep monitoring for 30 days. A subset of this group will undergo 2 overnight polysomnography studies

Dietary Supplement: Proprietary Spearmint Extract Blend

Control

PLACEBO COMPARATOR

Subjects randomized into the active treatment group will be asked to consume 500 mg/day of the excipient, microcrystalline cellulose by mouth every night 30 mins before bed, complete a sleep diary upon waking and wear a Fitbit Charge 2 device for sleep monitoring for 30 days. A subset of this group will undergo 2 overnight polysomnography studies

Other: Control

Interventions

Proprietary Spearmint Extract Blend DIETARY_SUPPLEMENT

Water extracted spearmint extract and green tea blend

Proprietary Spearmint Extract Blend

Control OTHER

Placebo

Control

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be included in the study, patients must:
• Subject is a male or female, 22-50 years of age, inclusive.
• Subject is judged by the Investigator to be in general good health on the basis of medical history.
• Subject is a non-user of nicotine products for 6 months prior to screening.
• Subject's initial online screen reveals a score \>5 on the PSQI.
• Subject has a BMI of 18.50-29.99 kg/m2, inclusive, at screening.
• Subject is willing to maintain habitual diet and activity patterns throughout the study period, other than the study instructions given for caffeine, alcohol, and vigorous physical activity.
• Subject is willing to consume study product 30 minutes before bed throughout the study period.
• Subject will consume no more than 14 alcoholic drinks (12oz beer, 5oz wine, 1.5oz distilled spirits) per week while in the study, no more than 4 drinks on a single occasion, and no more than 1 alcoholic drink within 4 hours of bedtime.
• Subject will consume no more than 4 servings of caffeine substances per day (8oz coffee, 1oz espresso, 12oz caffeinated soda, 8oz energy drink) and no caffeine within 6 hours of bedtime.
• Subject will refrain from vigorous physical activity (causing sweating) within 2 hours of bedtime.
• Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

You may not qualify if:

• Subject has a history or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, chronic pain condition(s), or neurologic disorders.
• Subject has an active infection or signs/symptoms of an infection. Clinic visits and/or sleep evaluations will be rescheduled to allow subject to be symptom-free of any type of systemic infection for at least 5 days.
• Subject has uncontrolled hypertension (systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg) at screening.
• Subject has a known allergy or sensitivity to any ingredients in the study products.
• Subject is a heavy consumer of caffeinated beverages (\>400 mg caffeine/d from caffeine-containing products) within 2 weeks of screening.
• Subject diagnosed with a psychiatric disorder that would impair their ability to perform the study, such as a psychotic disorder, bipolar disorder, neurodevelopmental disorder, post-traumatic stress disorder, etc. The subject should not currently be experiencing a major depressive episode. Psychiatric history will be assessed at screening then reassessed at the screening visit; In addition, the Mini International Neuropsychiatric Inventory will be conducted at the screening visit.
• Subject has a history of use of psychotropic medications (including antidepressants, beta-blockers, and tranquilizers), stimulant medications, medical marijuana and/or narcotics within 4 weeks of screening.
• Subject has used sleep aid medications, supplements, and/or products (over-the-counter or prescription), including antihistamines, within 2 weeks of screening. If use has occurred a wash-out period can be conducted.
• Subject has a history of unconventional sleep patterns (e.g., night shift), chronic insomnia (defined as insomnia at least 3 d/week over the past month), a diagnosed sleep disorder (e.g., OSA), or a chronic medical condition that may impact energy/fatigue levels, in the judgment of the Investigator.
• Subject has a history of cancer within 5 years prior to screening except for non-melanoma skin cancer.
• Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to use of a medically approved form of contraception throughout the study period.
• Subject has a current or recent history (past 12 months of screening) or strong potential for drug or alcohol abuse. Alcohol abuse will be defined as \> 14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 1.5 oz. hard liquor).
• Subject has been exposed to any non-registered drug product within 30 d prior to screening.
• Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, might confound the interpretation of the study results, or put the person at undue risk.

Sponsors & Collaborators

• University of Arizona: lead
• Kemin Foods LC: collaborator

Study Sites (1)

University of Arizona Dept of Psychiatry Research facilities

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

• 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.

  PMID: 33809544 DERIVED

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.

Results Point of Contact

• Title: Dr Michael Grandner
• Organization: The University of Arizona

grandner@email.arizona.edu

15206266346

Study Officials

• Michael Grandner, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry, Psychology, and Medicine Director, Sleep & Health Research Program

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 25, 2018
• Study Start: May 18, 2018
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: July 18, 2024
• Results First Posted: July 18, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)