The Effects of A Proprietary Spearmint Extract on Cognitive Performance

NCT02518165 | Completed

• 1 other identifier: 14HUS003
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood; Cognitive Performance; Sleep

Keywords

Cognitive Domain: Speed; Cognitive Domain: Reaction Time; Cognitive Domain: Attention; Cognitive Domain: Executive Function; Cognitive Domain Memory; Sleep Quality; Sleep Efficiency

Outcome Measures

Primary Outcomes (1)

• Choice reaction time as assessed by the Makoto Arena Device

  Change from baseline after 90 days of supplementation

Secondary Outcomes (3)

• 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

• Subjective mood as assessed using a Likert scale questionnaire

  Change from baseline after 90 days of supplementation

• 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.

Study Arms (2)

Proprietary spearmint extract

ACTIVE COMPARATOR

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

Microcrystalline cellulose

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Proprietary spearmint extract DIETARY_SUPPLEMENT

Water extracted spearmint extract

Proprietary spearmint extract

Placebo OTHER

Microcrystalline Cellulose

Microcrystalline cellulose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kemin Foods LC: lead
• MusclePharm Sports Science Institute: collaborator

Study Sites (1)

Musclepharm Sports Science Institute

Denver, Colorado, 80239, United States

Location

Related Publications (1)

• Falcone PH, Tribby AC, Vogel RM, Joy JM, Moon JR, Slayton CA, Henigman MM, Lasrado JA, Lewis BJ, Fonseca BA, Nieman KM, Herrlinger KA. Efficacy of a nootropic spearmint extract on reactive agility: a randomized, double-blind, placebo-controlled, parallel trial. J Int Soc Sports Nutr. 2018 Dec 12;15(1):58. doi: 10.1186/s12970-018-0264-5.

  PMID: 30541572 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jordan R Moon, PhD

  MusclePharm Sports Science Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 7, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2017
• Last Updated: January 31, 2018

Record last verified: 2018-01

Locations

US (1)