Cognitive Effects of Mint Essential Oil

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

Sponsors

Lead Sponsor: Northumbria University

Collaborator: Procter and Gamble

Source Northumbria University
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.

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).

Overall Status Completed
Start Date 2016-03-14
Completion Date 2016-06-09
Primary Completion Date 2016-06-09
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in cognition 1, 3 and 6 hrs post-dose
Secondary Outcome
Measure Time Frame
Changes in mood 1, 3 and 6 hrs post-dose
Neurotransmitter receptor binding efficacy 0 hrs
Acetylcholinesterase inhibition 0 hrs
Quantification of monoterpene levels 0 hrs
Enrollment 24
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Mentha piperita

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

Other Name: Peppermint

Intervention Type: Dietary Supplement

Intervention Name: Placebo

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

Arm Group Label: Placebo

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

35 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
David O Kennedy, PhD Principal Investigator Northumbria University
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Verification Date

2018-03-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Northumbria University

Investigator Full Name: David Kennedy

Investigator Title: Professor

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Label: Placebo

Type: Placebo Comparator

Description: Vegetable oil

Label: High-dose mint essential oil

Type: Active Comparator

Description: 100 μL Mentha piperita essential oil (in vegetable oil)

Label: Low-dose mint essential oil

Type: Active Comparator

Description: 50 μL Mentha piperita essential oil (in vegetable oil)

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: Randomised, placebo controlled, crossover

Primary Purpose: Other

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News