- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05561543
Effects of Peppermint Oil in Mild-moderate Hypertension.
Effects of Peppermint Oil in Cardiometabolic Outcomes in Participants With Mild-moderate Hypertension.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lancashire
-
Preston, Lancashire, United Kingdom, PR4 0PE
- University of Central Lancashire
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged from 18-65 years
- Systolic blood pressure 120 to 139 mmHg
- Not taking prescribed medicine for blood pressure management
- have the ability to complete written questionnaires independently
- Able to provide informed consent
Exclusion Criteria:
- diagnosed diabetes mellitus
- known cardiovascular disease or clinically significant cardiovascular comorbidity, including coronary heart disease, symptomatic heart failure, clinically significant arrhythmia, or a history of stroke or transient ischaemic attack within the previous 6 months
- known or suspected secondary hypertension, including renal, renovascular, or endocrine causes
- known clinically significant renal impairment or severe hepatic disease
- evidence or history of severe hypertension related target organ damage requiring specialist management
- pregnant or lactating women
- allergy to peppermint
- habitual consumption of peppermint products
- regular consumption of antioxidant supplements
- body mass index larger than 40.0 kg/m²
- current enrolment in other clinical trials or use of other external therapies likely to influence outcomes
- condition(s) likely to compromise informed consent, protocol compliance, or outcome assessment, including severe psychiatric illness, cognitive impairment, or active substance or alcohol misuse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
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.
|
Placebo
|
|
Experimental: Peppermint oil
50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day.
|
Peppermint oil
|
What is the study measuring?
Primary Outcome Measures
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Waist circumference
Time Frame: Baseline
|
Waist circumference - measured using anthropocentric tape
|
Baseline
|
|
Waist circumference
Time Frame: 20 days
|
Waist circumference - measured using anthropocentric tape
|
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
|
|
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
|
|
Triglyceride glucose index
Time Frame: Baseline
|
Log transformed measurement of the blood glucose and blood triglyceride measures outlined above.
|
Baseline
|
|
Triglyceride glucose index
Time Frame: 20 days
|
Log transformed measurement of the blood glucose and blood triglyceride measures outlined above.
|
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
|
|
Diastolic blood pressure
Time Frame: Baseline
|
Diastolic blood pressure - measured using a digital blood pressure monitor
|
Baseline
|
|
Diastolic blood pressure
Time Frame: 20 days
|
Diastolic blood pressure - measured using a digital blood pressure monitor
|
20 days
|
|
Percent bodyfat and fat mass
Time Frame: Baseline
|
Participants percentage composition of fat - measured using bio-electrical impedance
|
Baseline
|
|
Percent bodyfat and fat mass
Time Frame: 20 days
|
Participants percentage composition of fat - measured using bio-electrical impedance
|
20 days
|
|
Total and HDL cholesterol ratio
Time Frame: Baseline
|
Ratio of total cholesterol to HDL cholesterol
|
Baseline
|
|
Total and HDL cholesterol ratio
Time Frame: 20 days
|
Ratio of total cholesterol to HDL cholesterol
|
20 days
|
|
LDL and HDL cholesterol ratio
Time Frame: Baseline
|
Ratio of LDL to HDL cholesterol
|
Baseline
|
|
Total and HDL cholesterol ratio
Time Frame: 20 days
|
Ratio of LDL to HDL cholesterol
|
20 days
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Peppermint oil hypertension
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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