Effects of Peppermint Oil in Cardiometabolic Outcomes

March 28, 2023 updated by: Jonathan Sinclair, University of Central Lancashire

Effects of Oral Peppermint Supplementation on Cardiometabolic Parameters

Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. Previous non-randomized interventions have shown that oral peppermint may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.

Therefore, the primary purpose of the proposed investigation is to test the ability of oral peppermint oil supplementation to improve cardiometabolic parameters in healthy individuals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Lancashire
      • Preston, Lancashire, United Kingdom, PR4 0PE
        • Jonathan Sinclair

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • Between 18 & 65 years
  • Non-smoker
  • BMI < 30
  • Able to give informed consent

Exclusion Criteria:

  • Pregnancy
  • Diabetes or any other metabolic/ uncontrolled hypertensive conditions
  • Food allergies to peppermint
  • Habitual consumption of peppermint
  • Not regularly taking medication or antioxidant supplements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Identical in taste and colour to the supplement juice, but with no peppermint content.
Other: Placebo
Placebo
Experimental: Peppermint oil
50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day.
Dietary supplement: Peppermint oil.
Peppermint oil.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: Baseline
Systolic blood pressure - measured using a digital blood pressure monitor
Baseline
Systolic blood pressure
Time Frame: 20 days
Systolic blood pressure - measured using a digital blood pressure monitor
20 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent bodyfat
Time Frame: Baseline
Participants percentage composition of fat - measured using bio-electrical impedance
Baseline
Percent bodyfat
Time Frame: 20 days
Participants percentage composition of fat - measured using bio-electrical impedance
20 days
Waist to hip ratio
Time Frame: Baseline
Ratio of waist to hip circumference - measured using anthropocentric tape
Baseline
Waist to hip ratio
Time Frame: 20 days
Ratio of waist to hip circumference - measured using anthropocentric tape
20 days
Resting metabolic rate
Time Frame: Baseline
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Baseline
Resting metabolic rate
Time Frame: 20 days
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
20 days
Resting utilization of carbohydrates
Time Frame: Baseline
Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Baseline
Resting utilization of carbohydrates
Time Frame: 20 days
Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
20 days
Resting utilization of fats
Time Frame: Baseline
Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Baseline
Resting utilization of fats
Time Frame: 20 days
Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
20 days
Blood glucose
Time Frame: Baseline
Capillary blood glucose - mmol/L
Baseline
Blood glucose
Time Frame: 20 days
Capillary blood glucose - mmol/L
20 days
Blood triglycerides
Time Frame: Baseline
Capillary blood triglycerides - mmol/L
Baseline
Blood triglycerides
Time Frame: 20 days
Capillary blood triglycerides - mmol/L
20 days
Blood cholesterol (Total, HDL & LDL)
Time Frame: Baseline
Capillary blood cholesterol - mmol/L
Baseline
Blood cholesterol (Total, HDL & LDL)
Time Frame: 20 days
Capillary blood cholesterol - mmol/L
20 days
Coop-Wonka chart
Time Frame: Baseline
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.
Baseline
Coop-Wonka chart
Time Frame: 20 days
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.
20 days
Beck Depression Inventory
Time Frame: Baseline
Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.
Baseline
Beck Depression Inventory
Time Frame: 20 days
Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.
20 days
State Trait Anxiety Inventory
Time Frame: Baseline
Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.
Baseline
State Trait Anxiety Inventory
Time Frame: 20 days
Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.
20 days
Insomnia Severity Index
Time Frame: Baseline
Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.
Baseline
Insomnia Severity Index
Time Frame: 20 days
Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.
20 days
Pittsburgh Sleep Quality Index
Time Frame: Baseline
Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.
Baseline
Pittsburgh Sleep Quality Index
Time Frame: 20 days
Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.
20 days
Epworth Sleepiness Scale
Time Frame: Baseline
Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.
Baseline
Epworth Sleepiness Scale
Time Frame: 20 days
Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.
20 days
Blood haemoglobin
Time Frame: Baseline
Capillary blood haemoglobin - g/L
Baseline
Blood haemoglobin
Time Frame: 20 days
Capillary blood haemoglobin - g/L
20 days
Triglyceride glucose index
Time Frame: Baseline
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Baseline
Triglyceride glucose index
Time Frame: 20 days
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
20 days
Diastolic blood pressure
Time Frame: Baseline
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Baseline
Diastolic blood pressure
Time Frame: 20 days
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Central Lancashire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Peppermint oil cardiometabolic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Sponsor/Collaborators

Locations

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