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Cognitive Effects of Mint Essential Oil

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: NCT03475836
Recruitment Status : Completed
First Posted : March 23, 2018
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
David Kennedy, Northumbria University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cognitive Change Affect Dietary Supplement: Mentha piperita Dietary Supplement: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomised, placebo controlled, crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double blind. Treatments were prepared and coded by a third party researcher who had no further involvement with the study.
Primary Purpose: Other
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
Actual Study Start Date : March 14, 2016
Actual Primary Completion Date : June 9, 2016
Actual Study Completion Date : June 9, 2016
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Vegetable oil
 Dietary Supplement: Placebo
Inert placebo control in the form of vegetable oil. This matches the vegetable oil in the active intervention condition.
Active Comparator: High-dose mint essential oil
100 μL Mentha piperita essential oil (in vegetable oil)
 Dietary Supplement: Mentha piperita
Commercially available essential oil suspended in an off-the-shelf vegetable oil.
Other Name: Peppermint
Active Comparator: Low-dose mint essential oil
50 μL Mentha piperita essential oil (in vegetable oil)
 Dietary Supplement: Mentha piperita
Commercially available essential oil suspended in an off-the-shelf vegetable oil.
Other Name: Peppermint


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes in mood [ Time Frame: 1, 3 and 6 hrs post-dose ]
    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.

  2. Neurotransmitter receptor binding efficacy [ Time Frame: 0 hrs ]
    In Vitro analysis of investigational product for GABAA, neuronal nicotinic and NMDA glutamate receptor binding efficacy utilizing radioligand competition binding assays

  3. Acetylcholinesterase inhibition [ Time Frame: 0 hrs ]
    In Vitro analysis of investigational product for acetylcholinesterase inhibition as described in Okello, Coleman and Seal (2015)

  4. Quantification of monoterpene levels [ Time Frame: 0 hrs ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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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): NCT03475836


Sponsors and Collaborators
Northumbria University
Procter and Gamble
Investigators
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Principal Investigator: David O Kennedy, PhD Northumbria University
More Information
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Responsible Party: David Kennedy, Professor, Northumbria University
ClinicalTrials.gov Identifier: NCT03475836    
Other Study ID Numbers: SUB052_Forster_040216
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No plan is currently available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Kennedy, Northumbria University:
Mentha
Mint
Essential oil
 Cognition
Mood
Humans