The Effects of A Proprietary Spearmint Extract on Cognitive Performance

Sleep Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518165
• Other study ID #: 14HUS003
• Status: Completed
• Phase: N/A
• First received: July 30, 2015
• Last updated: January 29, 2018
• Start date: April 2015
• Est. completion date: April 2017

Study information

• Verified date: January 2018
• Source: Kemin Foods LC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Performance
• Mood
• Sleep

Intervention

Dietary Supplement:
• Proprietary spearmint extract
Water extracted spearmint extract

Other:
• Placebo
Microcrystalline Cellulose

Locations

Country	Name	City	State
United States	Musclepharm Sports Science Institute	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Kemin Foods LC	MusclePharm Sports Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choice reaction time as assessed by the Makoto Arena Device		Change from baseline after 90 days of supplementation
Secondary	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
Secondary	Subjective mood as assessed using a Likert scale questionnaire		Change from baseline after 90 days of supplementation
Secondary	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.