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临床试验/NCT03475836
NCT03475836已完成不适用

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

Northumbria University0 个研究点目标入组 24 人开始时间: 2016年3月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
主要终点
Changes in cognition

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Double blind. Treatments were prepared and coded by a third party researcher who had no further involvement with the study.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Placebo

Placebo Comparator

Vegetable oil

干预措施: Placebo (Dietary Supplement)

High-dose mint essential oil

Active Comparator

100 μL Mentha piperita essential oil (in vegetable oil)

干预措施: Mentha piperita (Dietary Supplement)

Low-dose mint essential oil

Active Comparator

50 μL Mentha piperita essential oil (in vegetable oil)

干预措施: Mentha piperita (Dietary Supplement)

结局指标

主要结局

Changes in cognition

时间窗: 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.

次要结局

  • Acetylcholinesterase inhibition(0 hrs)
  • Changes in mood(1, 3 and 6 hrs post-dose)
  • Quantification of monoterpene levels(0 hrs)
  • Neurotransmitter receptor binding efficacy(0 hrs)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Kennedy

Professor

Northumbria University

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