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Completed

NCT Number: NCT02518165

The Effects of A Proprietary Spearmint Extract on Cognitive Performance

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Musclepharm Sports Science Institute

Denver, Colorado, 80239, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Proprietary spearmint extract

Dietary Supplement

Water extracted spearmint extract

Placebo

Other

Microcrystalline Cellulose

Primary outcomes

  1. Choice reaction time as assessed by the Makoto Arena Device

    Time frame: Change from baseline after 90 days of supplementation

Secondary outcomes

  1. Cognitive function (speed, reaction time, attention, executive function, memory, and motor speed) as assessed by a computerized test battery

    Time frame: Change from baseline after 90 days of supplementation

  2. Subjective mood as assessed using a Likert scale questionnaire

    Time frame: Change from baseline after 90 days of supplementation

  3. Subjective sleep quality and efficiency as assessed using Likert and visual analog scale questionnaires

    Time frame: Change from baseline after 90 days of supplementation or between group comparisons at day 90.

Sponsors and collaborators

Lead sponsor

Kemin Foods LC

Industry

Collaborators

  • MusclePharm Sports Science Institute

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 7, 2015
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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