Cognitive Performance, Mood, Sleep
Conditions
Keywords
Cognitive Domain: Speed, Cognitive Domain: Reaction Time, Cognitive Domain: Attention, Cognitive Domain: Executive Function, Cognitive Domain Memory, Sleep Quality, Sleep Efficiency
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.
Interventions
DIETARY_SUPPLEMENTProprietary spearmint extract
Water extracted spearmint extract
OTHERPlacebo
Microcrystalline Cellulose
Sponsors
MusclePharm Sports Science Institute
Kemin Foods LC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Choice reaction time as assessed by the Makoto Arena Device | Change from baseline after 90 days of supplementation |
Secondary
| Measure | 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. |
Countries
United States
Outcome results
None listed