Effects of Peppermint Oil in Mild-moderate Hypertension. A Pilot Feasibility Study.

Hypertension Clinical Trial

Official title:

Effects of Peppermint Oil in Cardiometabolic Outcomes in Participants With Mild-moderate Hypertension. A Pilot Feasibility Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05561543
• Other study ID #: Peppermint oil hypertension
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: July 2023
• Source: University of Central Lancashire
• Contact: Jonathan Sinclair, DSc
• Phone: +447875651533
• Email: jksinclair[@]uclan.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cardiovascular and associated hypertensive diseases are the leading health burden and cause of mortality worldwide; therefore, the necessity for effective interventions is paramount. Dietary interventions to improve cardiovascular health are highly sought after as they possess less risk and financial burden than pharmacological drugs. Our previous randomized trial has shown that oral peppermint can improving systolic blood pressure and other cardiovascular/ blood lipids in healthy individuals. However, to date, no research has explored this using a placebo randomized intervention in patients with hypertension. Therefore, the primary purpose of the proposed investigation is to test the ability of oral peppermint oil supplementation to improve cardiometabolic parameters in participants with mild-moderate hypertension.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Meet 3 of 5 criteria for Metabolic Syndrome based on National Cholesterol Education

Program-Adult Treatment Panel III guidelines:

1. Waist Circumference: >102cm (men), >88cm (women)

2. Fasting Triglycerides: =1.69 mmol.L-1

3. Fasting High Density Lipoprotein: <1.03 mmol.L-1 (men), <1.29 mmol.L-1 (women)

4. Blood Pressure: =130 mmHg SBP or =85 mmHg DBP

5. Fasting Glucose: =6.1 mmol.L-1

Exclusion Criteria:

• Smoking current
• Current or previous gastrointestinal, cardiovascular, hepatic or renal disease
• Current diabetes or extreme hypertension (=160/100 mmHg)
• Allergy to peppermint
• Current medication (such as steroids, NSAIDs, antibiotics, antihypertensive, hypoglycaemic, lipid-lowering drugs)
• Currently using any nutritional supplement.
• Heavy alcohol consumption (>14 units per week).

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Hypertension
• Metabolic Syndrome

Intervention

Dietary Supplement:
• Peppermint oil
Peppermint oil

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Central Lancashire	University of Hertfordshire

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	Diastolic blood pressure	Diastolic blood pressure - measured using a digital blood pressure monitor	Baseline
Secondary	Diastolic blood pressure	Diastolic 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 circumference	Waist circumference - measured using anthropocentric tape	Baseline
Secondary	Waist circumference	Waist circumference - measured using anthropocentric tape	20 days
Secondary	Waist to hip ratio	Ratio of waist to hip circumference - measured using anthropocentric tape	Baseline
Secondary	Waist to hip ratio	Ratio of waist to hip circumference - measured using anthropocentric tape	20 days
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.	Baseline
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 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	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	Capillary blood haemoglobin	Capillary blood haemoglobin - g/L	Baseline
Secondary	Capillary blood haemoglobin	Capillary blood haemoglobin - g/L	20 days
Secondary	Triglyceride glucose index	Log transformed measurement of the blood glucose and blood triglyceride measures outlined above.	Baseline
Secondary	Triglyceride glucose index	Log transformed measurement of the blood glucose and blood triglyceride measures outlined above.	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	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.	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.	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.	Baseline
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	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