The Effects of A Proprietary Spearmint Extract on Cognitive Performance

January 29, 2018 updated by: Kemin Foods LC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80239
        • MusclePharm Sports Science Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Proprietary spearmint extract
Subjects randomized into the active treatment group will be asked to consume 900 mg/day of the proprietary spearmint extract.
Dietary supplement: Proprietary spearmint extract
Water extracted spearmint extract
Placebo Comparator: Microcrystalline cellulose
Subjects randomized into the placebo group will be asked to consume 900 mg/day of the excipient, microcrystalline cellulose.
Other: Placebo
Microcrystalline Cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Choice reaction time as assessed by the Makoto Arena Device
Time Frame: Change from baseline after 90 days of supplementation
Change from baseline after 90 days of supplementation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Change from baseline after 90 days of supplementation
Subjective mood as assessed using a Likert scale questionnaire
Time Frame: Change from baseline after 90 days of supplementation
Change from baseline after 90 days of supplementation
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.
Change from baseline after 90 days of supplementation or between group comparisons at day 90.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kemin Foods LC

Collaborators

MusclePharm Sports Science Institute

Investigators

  • Principal Investigator: Jordan R Moon, PhD, MusclePharm Sports Science Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

August 6, 2015

First Posted (Estimate)

August 7, 2015

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14HUS003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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