Effects of Peppermint Oil in Cardiometabolic Outcomes

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: Completed
• Conditions: Cardiometabolic Syndrome
• Intervention / Treatment: Other: Placebo; Dietary supplement: Peppermint oil.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	Systolic blood pressure - measured using a digital blood pressure monitor	Baseline
Systolic blood pressure	Systolic blood pressure - measured using a digital blood pressure monitor	20 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent bodyfat	Participants percentage composition of fat - measured using bio-electrical impedance	Baseline
Percent bodyfat	Participants percentage composition of fat - measured using bio-electrical impedance	20 days
Waist to hip ratio	Ratio of waist to hip circumference - measured using anthropocentric tape	Baseline
Waist to hip ratio	Ratio of waist to hip circumference - measured using anthropocentric tape	20 days
Resting metabolic rate	Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.	Baseline
Resting metabolic rate	Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.	20 days
Resting utilization of carbohydrates	Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.	Baseline
Resting utilization of carbohydrates	Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.	20 days
Resting utilization of fats	Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.	Baseline
Resting utilization of fats	Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.	20 days
Blood glucose	Capillary blood glucose - mmol/L	Baseline
Blood glucose	Capillary blood glucose - mmol/L	20 days
Blood triglycerides	Capillary blood triglycerides - mmol/L	Baseline
Blood triglycerides	Capillary blood triglycerides - mmol/L	20 days
Blood cholesterol (Total, HDL & LDL)	Capillary blood cholesterol - mmol/L	Baseline
Blood cholesterol (Total, HDL & LDL)	Capillary blood cholesterol - mmol/L	20 days
Coop-Wonka chart	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	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	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	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	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	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	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	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	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	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	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	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	Capillary blood haemoglobin - g/L	Baseline
Blood haemoglobin	Capillary blood haemoglobin - g/L	20 days
Triglyceride glucose index	Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)	Baseline
Triglyceride glucose index	Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)	20 days
Diastolic blood pressure	Systolic and diastolic blood pressure - measured using a digital blood pressure monitor	Baseline
Diastolic blood pressure	Systolic and diastolic blood pressure - measured using a digital blood pressure monitor	20 days

Collaborators and Investigators

• Sponsor: University of Central Lancashire

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): November 5, 2022

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Physiological Effects of Drugs; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Peppermint oil
• Other Study ID 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