ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02518165
Previous Study | Return to List | Next Study

The Effects of A Proprietary Spearmint Extract on Cognitive Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02518165
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
MusclePharm Sports Science Institute
Information provided by (Responsible Party):
Kemin Foods LC

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.

Condition or disease Intervention/treatment Phase
Mood Cognitive Performance Sleep Dietary Supplement: Proprietary spearmint extract Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
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 Start Date : April 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Choice reaction time as assessed by the Makoto Arena Device [ Time Frame: Change from baseline after 90 days of supplementation ]

Secondary Outcome Measures :
  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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518165


Locations
United States, Colorado
Musclepharm Sports Science Institute
Denver, Colorado, United States, 80239
Sponsors and Collaborators
Kemin Foods LC
MusclePharm Sports Science Institute
Investigators
Principal Investigator: Jordan R Moon, PhD MusclePharm Sports Science Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kemin Foods LC
ClinicalTrials.gov Identifier: NCT02518165     History of Changes
Other Study ID Numbers: 14HUS003
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Keywords provided by Kemin Foods LC:
Cognitive Domain: Speed
Cognitive Domain: Reaction Time
Cognitive Domain: Attention
Cognitive Domain: Executive Function
Cognitive Domain Memory
Sleep Quality
Sleep Efficiency