The Effects of A Proprietary Spearmint Extract on Cognitive Performance

Study Overview
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel Trial to Assess the Effects of A Proprietary Spearmint Extract on Cognitive Performance, Mood, and Sleep in Men and Women

Conditions
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Mood, Cognitive Performance, Sleep

Intervention / Treatment
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* Dietary Supplement: Proprietary spearmint extract
* Other: Placebo


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Proprietary spearmint extract<br>Subjects randomized into the active treatment group will be asked to consume 900 mg/day of the proprietary spearmint extract. | Dietary Supplement: Proprietary spearmint extract<br>* Water extracted spearmint extract<br>|
| Placebo Comparator: Microcrystalline cellulose<br>Subjects randomized into the placebo group will be asked to consume 900 mg/day of the excipient, microcrystalline cellulose. | Other: Placebo<br>* Microcrystalline Cellulose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choice reaction time as assessed by the Makoto Arena Device |  | Change from baseline after 90 days of supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function (speed, reaction time, attention, executive function, memory, and motor speed) as assessed by a computerized test battery |  | Change from baseline after 90 days of supplementation | 
| Subjective mood as assessed using a Likert scale questionnaire |  | Change from baseline after 90 days of supplementation | 
| Subjective sleep quality and efficiency as assessed using Likert and visual analog scale questionnaires |  | Change from baseline after 90 days of supplementation or between group comparisons at day 90. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Domain Memory, Cognitive Domain: Speed, Cognitive Domain: Reaction Time, Cognitive Domain: Attention, Cognitive Domain: Executive Function, Sleep Quality, Sleep Efficiency