The Effects of A Proprietary Spearmint Extract on Cognitive Performance

Kemin Foods

Status: Completed

Conditions: Cognitive Performance; Mood; Sleep

Treatments: Dietary Supplement: Proprietary spearmint extract; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02518165

14HUS003

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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142 participants in 2 patient groups, including a placebo group

Proprietary spearmint extract

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Proprietary spearmint extract

Microcrystalline cellulose

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo