NCT03475836

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

February 13, 2018

Last Update Submit

March 22, 2018

Conditions

Cognitive ChangeAffect

Keywords

MenthaMintEssential oilCognitionMoodHumans

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Changes in mood

    1, 3 and 6 hrs post-dose

  • Neurotransmitter receptor binding efficacy

    0 hrs

  • Acetylcholinesterase inhibition

    0 hrs

  • Quantification of monoterpene levels

    0 hrs

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Vegetable oil

Dietary Supplement: Placebo

High-dose mint essential oil

ACTIVE COMPARATOR

100 μL Mentha piperita essential oil (in vegetable oil)

Dietary Supplement: Mentha piperita

Low-dose mint essential oil

ACTIVE COMPARATOR

50 μL Mentha piperita essential oil (in vegetable oil)

Dietary Supplement: Mentha piperita

Interventions

Mentha piperitaDIETARY_SUPPLEMENT

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

Also known as: Peppermint
High-dose mint essential oilLow-dose mint essential oil
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • yrs
  • Free from illicit drugs, alcohol, prescription medication (apart from contraception in the case of women) and herbal extracts/food supplements at each assessment.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

peppermint oil

Study Officials

  • David O Kennedy, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind. Treatments were prepared and coded by a third party researcher who had no further involvement with the study.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomised, placebo controlled, crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2018

First Posted

March 23, 2018

Study Start

March 14, 2016

Primary Completion

June 9, 2016

Study Completion

June 9, 2016

Last Updated

March 23, 2018

Record last verified: 2018-03