Cognitive Effects of Mint Essential Oil

Cognitive Change Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475836
• Other study ID #: SUB052_Forster_040216
• Status: Completed
• Phase: N/A
• First received: February 13, 2018
• Last updated: March 22, 2018
• Start date: March 14, 2016
• Est. completion date: June 9, 2016

Study information

• Verified date: March 2018
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 9, 2016
• Est. primary completion date: June 9, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Affect
• Cognitive Change

Intervention

Dietary Supplement:
• Mentha piperita
Commercially available essential oil suspended in an off-the-shelf vegetable oil.
• Placebo
Inert placebo control in the form of vegetable oil. This matches the vegetable oil in the active intervention condition.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	Procter and Gamble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cognition	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.	1, 3 and 6 hrs post-dose
Secondary	Changes in mood	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.	1, 3 and 6 hrs post-dose
Secondary	Neurotransmitter receptor binding efficacy	In Vitro analysis of investigational product for GABAA, neuronal nicotinic and NMDA glutamate receptor binding efficacy utilizing radioligand competition binding assays	0 hrs
Secondary	Acetylcholinesterase inhibition	In Vitro analysis of investigational product for acetylcholinesterase inhibition as described in Okello, Coleman and Seal (2015)	0 hrs
Secondary	Quantification of monoterpene levels	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).	0 hrs