MoodNCT02518165
The Effects of A Proprietary Spearmint Extract on Cognitive Performance
A study testing Proprietary spearmint extract in people with Mood and Cognitive Performance, run by Kemin Foods LC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood, Cognitive Performance, Sleep
- What is being tested?
- Proprietary spearmint extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Musclepharm Sports Science Institute
Denver, Colorado, 80239
About this study
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
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
- Being tested
- Proprietary spearmint extract, Placebo
- Keywords
- Cognitive Domain: Speed, Cognitive Domain: Reaction Time, Cognitive Domain: Attention, Cognitive Domain: Executive Function, Cognitive Domain Memory, Sleep Quality, Sleep Efficiency
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprietary spearmint extractDietary supplement
Water extracted spearmint extract
PlaceboOther
Microcrystalline Cellulose
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choice reaction time as assessed by the Makoto Arena Device
Measured: 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
Measured: Change from baseline after 90 days of supplementation
Subjective mood as assessed using a Likert scale questionnaire
Measured: Change from baseline after 90 days of supplementation
Subjective sleep quality and efficiency as assessed using Likert and visual analog scale questionnaires
Measured: Change from baseline after 90 days of supplementation or between group comparisons at day 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kemin Foods LC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MusclePharm Sports Science Institute
- Responsible party
- Sponsor
- Investigators
- Jordan R Moon, PhD, Principal investigator, MusclePharm Sports Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518165
- Sponsor's protocol ID
- 14HUS003
- Status last verified
- Jan 2018
- First submitted
- 30 Jul 2015
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30541572
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02518165
- Acronym / sponsor ID
- 14HUS003
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Kemin Foods LCIndustry (pharma, biotech, devices)
- Collaborators
- MusclePharm Sports Science Institute
- Study start
- Apr 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprietary spearmint extract | Active comparator | Dietary Supplement: Proprietary spearmint extractSubjects randomized into the active treatment group will be asked to consume 900 mg/day of the proprietary spearmint extract. |
| Microcrystalline cellulose | Placebo comparator | Other: PlaceboSubjects randomized into the placebo group will be asked to consume 900 mg/day of the excipient, microcrystalline cellulose. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprietary spearmint extractWater extracted spearmint extract | Dietary supplement | Proprietary spearmint extract |
| PlaceboMicrocrystalline Cellulose | Other | Microcrystalline cellulose |
Primary outcome
Choice reaction time as assessed by the Makoto Arena Device
Time frame: Change from baseline after 90 days of supplementation
3 secondary outcomes
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
Subjective mood as assessed using a Likert scale questionnaire
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Derived from this study: PubMed 30541572Falcone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan R Moon, PhD principal investigator
MusclePharm Sports Science Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprietary spearmint extract in people with Mood and Cognitive Performance, run by Kemin Foods LC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choice reaction time as assessed by the Makoto Arena Device (time frame: Change from baseline after 90 days of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02518165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.