The Effects of A Proprietary Spearmint Extract on Cognitive Performance

Not Applicable

Completed

• Conditions: Cognitive Performance; Sleep; Mood
• Interventions: Other: Placebo; Dietary Supplement: Proprietary spearmint extract

• Registration Number: NCT02518165
• Lead Sponsor: Kemin Foods LC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-08-06
• Study First Posted: 2015-08-07
• Primary Completion: 2017-01
• Study Completion: 2017-04
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microcrystalline cellulose	Placebo	Subjects randomized into the placebo group will be asked to consume 900 mg/day of the excipient, microcrystalline cellulose.
Proprietary spearmint extract	Proprietary spearmint extract	Subjects randomized into the active treatment group will be asked to consume 900 mg/day of the proprietary spearmint extract.

Primary Outcome Measures

Name	Time	Method
Choice reaction time as assessed by the Makoto Arena Device	Change from baseline after 90 days of supplementation

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Musclepharm Sports Science Institute; 🇺🇸 Denver, Colorado, United States