Cognitive ChangeNCT03475836
Cognitive Effects of Mint Essential Oil
A study testing Mentha piperita in people with Cognitive Change and Affect, run by Northumbria University.
Trial summary
This study investigates the cognitive and mood effects of mint essential oils in a group of healthy, human adults. The investigational product will also be tested in vitro to ensure a number of biological mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Affect
- What is being tested?
- Mentha piperita
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2016to 9 Jun 2016
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 yrs
- Free from illicit drugs, alcohol, prescription medication (apart from contraception in the case of women) and herbal extracts/food supplements at each assessment.
Who cannot join
- Head injury, neurological disorder or neuro-developmental disorder
- English not 1st language (or not equivalent to a native English speaker)
- Relevant food allergies/intolerances or digestive problems
- Smokes tobacco
- Drinks excessive amounts of caffeine (more than 600mg day as assessed by a caffeine consumption questionnaire)
- Takes illicit social drugs
- Pregnant, seeking to become so, or breast feeding
About this study
Official title: Volatile Terpenes and Brain Function: Investigation of the Cognitive and Mood Effects of Mentha Spicata/Piperita Essential Oil With in Vitro Properties Relevant to Central Nervous System Function
This study investigates the cognitive and mood effects of mint essential oils in a group of healthy, human adults. The investigational product will also be tested in vitro to ensure a number of biological mechanisms.
Read the detailed description
The volatile components of essential oils (e.g. sage, lemon balm and rosemary)are found to exert a number of psychotropic effects and the monoterpenes in particular seem to be responsible for the cognitive and mood effects attributed to them.
The current study aims to investigate the cognitive and mood effects of mint essential oil in humans and to ensure the efficacy of the investigational product by conducting in vitro analysis on central nervous system receptor binding properties.
This will be achieved by analysing gamma-Aminobutyric acid A (GABAA), neuronal nicotinic and N-methyl-D-aspartate receptor (NMDA) glutamate receptor binding efficacy, acetylcholinesterase (AChE) inhibition, and gas chromatography-mass spectrometry (GC-MS) analysis will quantify % Limonene, % Carvone, % Menthone and % Menthol levels in the investigational treatment.
Cognitive and mood assessment will be via a randomised, placebo controlled, crossover design in 24, healthy adults aged between 18-35 yrs which will involve x1 training and x3 testing visits to the lab (placebo, 50 (micro Litre) μL and 100 μL Mentha piperita essential oil).
- Conditions
- Cognitive Change, Affect
- Being tested
- Mentha piperita, Placebo
- Keywords
- Mentha, Mint, Essential oil, Cognition, Mood, Humans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentha piperitaDietary supplement
Also called Peppermint
Commercially available essential oil suspended in an off-the-shelf vegetable oil.
PlaceboDietary supplement
Inert placebo control in the form of vegetable oil. This matches the vegetable oil in the active intervention condition.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Vegetable oil Receives: Dietary Supplement: Placebo |
| High-dose mint essential oil | Active comparator | 100 μL Mentha piperita essential oil (in vegetable oil) Receives: Dietary Supplement: Mentha piperita |
| Low-dose mint essential oil | Active comparator | 50 μL Mentha piperita essential oil (in vegetable oil) Receives: Dietary Supplement: Mentha piperita |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognition
Changes in cognitive function as assessed by the following tasks: immediate and delayed word and picture recognition; name to face recall; 'Sternberg' Numeric Working Memory task; Corsi blocks; serial 3 subtractions; serial 7 subtractions; rapid visual information processing; peg and ball and choice reaction time. All tasks provide an outcome measure of accuracy, speed and error.
Measured: 1, 3 and 6 hrs post-dose
Secondary outcomes (4)
Changes in mood
Changes in mood assessed via the Speilberger State-Trait Anxiety Inventory (STAI) and Bond-Lader visual analogue mood scales. Scores on both measures are calculated at baseline and scores from subsequent completions are subtracted from this to produce change (change from baseline) scores. For both STAI and Bond-Lader these are numerical scores.
Measured: 1, 3 and 6 hrs post-dose
Neurotransmitter receptor binding efficacy
In Vitro analysis of investigational product for GABAA, neuronal nicotinic and NMDA glutamate receptor binding efficacy utilizing radioligand competition binding assays
Measured: 0 hrs
Acetylcholinesterase inhibition
In Vitro analysis of investigational product for acetylcholinesterase inhibition as described in Okello, Coleman and Seal (2015)
Measured: 0 hrs
Quantification of monoterpene levels
In Vitro analysis of investigational product for levels of % Limonene, % Carvone, % Menthone and % Menthol utilizing Gas chromatography-mass spectrometry. The method is described in Abuhamdah et al. (2015).
Measured: 0 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start14 Mar 2016
- Primary completion9 Jun 2016
- Study completion9 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Crossover
- Model description
- Randomised, placebo controlled, crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Principal investigator, David Kennedy, Northumbria University
- Investigators
- David O Kennedy, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475836
- Sponsor's protocol ID
- SUB052_Forster_040216
- Status last verified
- Mar 2018
- First submitted
- 13 Feb 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plan is currently available
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volatile Terpenes and Brain Function: Investigation of the Cognitive and Mood Effects of Mentha Spicata/Piperita Essential Oil With in Vitro Properties Relevant to Central Nervous System Function
- ClinicalTrials.gov ID
- NCT03475836
- Acronym / sponsor ID
- SUB052_Forster_040216
- Conditions
- Cognitive Change, Affect
- Keywords
- Mentha, Mint, Essential oil, Cognition, Mood, Humans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- 14 Mar 2016 (actual)
- Primary completion
- 9 Jun 2016 (actual)
- Study completion
- 9 Jun 2016 (actual)
- First posted
- 23 Mar 2018 (actual)
- 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 investigates the cognitive and mood effects of mint essential oils in a group of healthy, human adults. The investigational product will also be tested in vitro to ensure a number of biological mechanisms.
Detailed description
The volatile components of essential oils (e.g. sage, lemon balm and rosemary)are found to exert a number of psychotropic effects and the monoterpenes in particular seem to be responsible for the cognitive and mood effects attributed to them.
The current study aims to investigate the cognitive and mood effects of mint essential oil in humans and to ensure the efficacy of the investigational product by conducting in vitro analysis on central nervous system receptor binding properties.
This will be achieved by analysing gamma-Aminobutyric acid A (GABAA), neuronal nicotinic and N-methyl-D-aspartate receptor (NMDA) glutamate receptor binding efficacy, acetylcholinesterase (AChE) inhibition, and gas chromatography-mass spectrometry (GC-MS) analysis will quantify % Limonene, % Carvone, % Menthone and % Menthol levels in the investigational treatment.
Cognitive and mood assessment will be via a randomised, placebo controlled, crossover design in 24, healthy adults aged between 18-35 yrs which will involve x1 training and x3 testing visits to the lab (placebo, 50 (micro Litre) μL and 100 μL Mentha piperita essential oil).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomised, placebo controlled, crossover
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboVegetable oil |
| High-dose mint essential oil | Active comparator | Dietary Supplement: Mentha piperita100 μL Mentha piperita essential oil (in vegetable oil) |
| Low-dose mint essential oil | Active comparator | Dietary Supplement: Mentha piperita50 μL Mentha piperita essential oil (in vegetable oil) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-35 yrs
- Free from illicit drugs, alcohol, prescription medication (apart from contraception in the case of women) and herbal extracts/food supplements at each assessment.
Key exclusion criteria (7 listed)
- Head injury, neurological disorder or neuro-developmental disorder
- English not 1st language (or not equivalent to a native English speaker)
- Relevant food allergies/intolerances or digestive problems
- Smokes tobacco
- Drinks excessive amounts of caffeine (more than 600mg day as assessed by a caffeine consumption questionnaire)
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 |
|---|---|---|
| Mentha piperitaAlso: PeppermintCommercially available essential oil suspended in an off-the-shelf vegetable oil. | Dietary supplement | High-dose mint essential oil, Low-dose mint essential oil |
| PlaceboInert placebo control in the form of vegetable oil. This matches the vegetable oil in the active intervention condition. | Dietary supplement | Placebo |
Primary outcome
Changes in cognition
Time frame: 1, 3 and 6 hrs post-dose
Changes in cognitive function as assessed by the following tasks: immediate and delayed word and picture recognition; name to face recall; 'Sternberg' Numeric Working Memory task; Corsi blocks; serial 3 subtractions; serial 7 subtractions; rapid visual information processing; peg and ball and choice reaction time. All tasks provide an outcome measure of accuracy, speed and error.
4 secondary outcomes
Changes in mood
Time frame: 1, 3 and 6 hrs post-dose
Neurotransmitter receptor binding efficacy
Time frame: 0 hrs
Acetylcholinesterase inhibition
Time frame: 0 hrs
Quantification of monoterpene levels
Time frame: 0 hrs
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 23 Mar 2018.
- Individual participant dataSharing planned: Undecided. No plan is currently available
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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.
David O Kennedy, PhD principal investigator
Northumbria University
Questions about this trial
What is this clinical trial studying?
A study testing Mentha piperita in people with Cognitive Change and Affect, run by Northumbria University.
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 2 inclusion and 7 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 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in cognition (time frame: 1, 3 and 6 hrs post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2018; AzTrials last refreshed its copy on 31 Oct 2026.