Clinical trial NCT03475836: Cognitive Effects of Mint Essential Oil
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Affect
Keywords: Mentha
Mint
Essential oil
Cognition
Mood
Humans
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2018-03-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, placebo controlled, crossover
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Changes in cognition
timeFrame: 1, 3 and 6 hrs post-dose
Secondary outcomes:
measure: Changes in mood
timeFrame: 1, 3 and 6 hrs post-dose
measure: Neurotransmitter receptor binding efficacy
timeFrame: 0 hrs
measure: Acetylcholinesterase inhibition
timeFrame: 0 hrs
measure: Quantification of monoterpene levels
timeFrame: 0 hrs
Other outcomes:
Locations:
Study officials:
affiliation: Northumbria University
name: David O Kennedy, PhD
role: PRINCIPAL_INVESTIGATOR
References: