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Cognitive Effects of Mint Essential Oil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03475836
Recruitment Status : Completed
First Posted : March 23, 2018
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
David Kennedy, Northumbria University

Tracking Information
First Submitted Date  ICMJE February 13, 2018
First Posted Date  ICMJE March 23, 2018
Last Update Posted Date March 23, 2018
Actual Study Start Date  ICMJE March 14, 2016
Actual Primary Completion Date June 9, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • 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.
  • 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
  • Acetylcholinesterase inhibition [ Time Frame: 0 hrs ]
    In Vitro analysis of investigational product for acetylcholinesterase inhibition as described in Okello, Coleman and Seal (2015)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Effects of Mint Essential Oil
Official Title  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Randomised, placebo controlled, crossover
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.
Primary Purpose: Other
Condition  ICMJE
  • Cognitive Change
  • Affect
Intervention  ICMJE
  • Dietary Supplement: Mentha piperita
    Commercially available essential oil suspended in an off-the-shelf vegetable oil.
    Other Name: Peppermint
  • Dietary Supplement: Placebo
    Inert placebo control in the form of vegetable oil. This matches the vegetable oil in the active intervention condition.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Vegetable oil
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: High-dose mint essential oil
    100 μL Mentha piperita essential oil (in vegetable oil)
    Intervention: Dietary Supplement: Mentha piperita
  • Active Comparator: Low-dose mint essential oil
    50 μL Mentha piperita essential oil (in vegetable oil)
    Intervention: Dietary Supplement: Mentha piperita
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2018)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 9, 2016
Actual Primary Completion Date June 9, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03475836
Other Study ID Numbers  ICMJE SUB052_Forster_040216
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: No plan is currently available
Current Responsible Party David Kennedy, Northumbria University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Northumbria University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Procter and Gamble
Investigators  ICMJE
Principal Investigator: David O Kennedy, PhD Northumbria University
PRS Account Northumbria University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP