Cognitive Effects of Mint Essential Oil

NCT ID: NCT03475836

Last Updated: 2018-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-14

Study Completion Date

2016-06-09

Brief Summary

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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

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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

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Cognitive Change Affect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised, placebo controlled, crossover
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double blind. Treatments were prepared and coded by a third party researcher who had no further involvement with the study.

Study Groups

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Placebo

Vegetable oil

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Inert placebo control in the form of vegetable oil. This matches the vegetable oil in the active intervention condition.

High-dose mint essential oil

100 μL Mentha piperita essential oil (in vegetable oil)

Group Type ACTIVE_COMPARATOR

Mentha piperita

Intervention Type DIETARY_SUPPLEMENT

Commercially available essential oil suspended in an off-the-shelf vegetable oil.

Low-dose mint essential oil

50 μL Mentha piperita essential oil (in vegetable oil)

Group Type ACTIVE_COMPARATOR

Mentha piperita

Intervention Type DIETARY_SUPPLEMENT

Commercially available essential oil suspended in an off-the-shelf vegetable oil.

Interventions

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Mentha piperita

Commercially available essential oil suspended in an off-the-shelf vegetable oil.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Inert placebo control in the form of vegetable oil. This matches the vegetable oil in the active intervention condition.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Peppermint

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role collaborator

Northumbria University

OTHER

Sponsor Role lead

Responsible Party

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David Kennedy

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David O Kennedy, PhD

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Other Identifiers

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SUB052_Forster_040216

Identifier Type: -

Identifier Source: org_study_id

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