Skip to main content
OpenTrials
Completed

NCT Number: NCT03475836

Cognitive Effects of Mint Essential Oil

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cognitive Change Affect

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mentha piperita

Dietary Supplement

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

Other names: Peppermint

Placebo

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • Procter and Gamble

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 23, 2018
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.