Effects of Peppermint Oil in Cardiometabolic Outcomes

Cardiometabolic Syndrome Clinical Trial

Official title:

Effects of Oral Peppermint Supplementation on Cardiometabolic Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071833
• Other study ID #: Peppermint oil cardiometabolic
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 5, 2022

Study information

• Verified date: March 2023
• Source: University of Central Lancashire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 5, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Metabolic Syndrome

Intervention

Dietary Supplement:
• Peppermint oil.
Peppermint oil.

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United Kingdom	Jonathan Sinclair	Preston	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Lancashire

Country where clinical trial is conducted

United Kingdom, 

Outcome

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