Clinical trial NCT02518165: The Effects of A Proprietary Spearmint Extract on Cognitive Performance
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood
Cognitive Performance
Sleep
Keywords: Cognitive Domain: Speed
Cognitive Domain: Reaction Time
Cognitive Domain: Attention
Cognitive Domain: Executive Function
Cognitive Domain Memory
Sleep Quality
Sleep Efficiency
Lead sponsor: Kemin Foods LC
Sponsor class: INDUSTRY
Collaborators: name: MusclePharm Sports Science Institute
First posted: 2015-08-07
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Choice reaction time as assessed by the Makoto Arena Device
timeFrame: Change from baseline after 90 days of supplementation
Secondary outcomes:
measure: Cognitive function (speed, reaction time, attention, executive function, memory, and motor speed) as assessed by a computerized test battery
timeFrame: Change from baseline after 90 days of supplementation
measure: Subjective mood as assessed using a Likert scale questionnaire
timeFrame: Change from baseline after 90 days of supplementation
measure: Subjective sleep quality and efficiency as assessed using Likert and visual analog scale questionnaires
timeFrame: Change from baseline after 90 days of supplementation or between group comparisons at day 90.
Other outcomes:
Locations:
city: Denver
country: United States
facility: Musclepharm Sports Science Institute
state: Colorado
Study officials:
affiliation: MusclePharm Sports Science Institute
name: Jordan R Moon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Falcone PH, Tribby AC, Vogel RM, Joy JM, Moon JR, Slayton CA, Henigman MM, Lasrado JA, Lewis BJ, Fonseca BA, Nieman KM, Herrlinger KA. Efficacy of a nootropic spearmint extract on reactive agility: a randomized, double-blind, placebo-controlled, parallel trial. J Int Soc Sports Nutr. 2018 Dec 12;15(1):58. doi: 10.1186/s12970-018-0264-5.