Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2016-03-14
2016-06-09
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Placebo
Vegetable oil
Placebo
Inert placebo control in the form of vegetable oil. This matches the vegetable oil in the active intervention condition.
High-dose mint essential oil
100 μL Mentha piperita essential oil (in vegetable oil)
Mentha piperita
Commercially available essential oil suspended in an off-the-shelf vegetable oil.
Low-dose mint essential oil
50 μL Mentha piperita essential oil (in vegetable oil)
Mentha piperita
Commercially available essential oil suspended in an off-the-shelf vegetable oil.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
35 Years
ALL
Yes
Sponsors
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Procter and Gamble
INDUSTRY
Northumbria University
OTHER
Responsible Party
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David Kennedy
Professor
Principal Investigators
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David O Kennedy, PhD
Role: PRINCIPAL_INVESTIGATOR
Northumbria University
Other Identifiers
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SUB052_Forster_040216
Identifier Type: -
Identifier Source: org_study_id
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