The Effects of A Proprietary Spearmint Extract on Cognitive Performance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-04-30

Brief Summary

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This study was designed to evaluate the chronic effects of a proprietary spearmint extract over 90 days of supplementation on aspects of cognitive performance (cognitive function and active reaction time), subjective mood, and sleep quality in healthy men and women.

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Detailed Description

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Conditions

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Mood Cognitive Performance Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Proprietary spearmint extract

Subjects randomized into the active treatment group will be asked to consume 900 mg/day of the proprietary spearmint extract.

Group Type ACTIVE_COMPARATOR

Proprietary spearmint extract

Intervention Type DIETARY_SUPPLEMENT

Water extracted spearmint extract

Microcrystalline cellulose

Subjects randomized into the placebo group will be asked to consume 900 mg/day of the excipient, microcrystalline cellulose.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Microcrystalline Cellulose

Interventions

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Proprietary spearmint extract

Water extracted spearmint extract

Intervention Type DIETARY_SUPPLEMENT

Placebo

Microcrystalline Cellulose

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and pre-menopausal women, 18-50 years of age.
* Body mass index 18.5-29.99 kg/m2, inclusive or body mass index 30.0-34.99 kg/m2 and body fat via bioimpedance \<39% for women aged 18-39y, \<40% for women aged 40-50y, \<25% for men aged 18-39y, \<28% for men aged 40-50y.
* Participant has at least a high school diploma or the equivalent.
* Participant is recreationally active.
* Participant is judged by the Investigator to be in general good health.
* Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators.

Exclusion Criteria

* Participant is unable to understand and/or perform required tests.
* Participant is unwilling to maintain normal dietary (including vitamins and supplements), exercise, sleep and medication patterns throughout the study.
* Participant is a habitual consumer of mint tea defined as \>8oz per day.
* Participant is regularly taking a cognitive enhancing supplement.
* Participant has a history or presence of a clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder.
* Participant has a sleep disorder or occupation where sleep during the overnight hours is irregular.
* Participant is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
* Participant is a current user of tobacco (defined as tobacco use within the previous 6 months).

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes