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

Primary Purpose

Hypertension, Cardiometabolic Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peppermint oil
Placebo
Sponsored by
University of Central Lancashire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Peppermint oil

    Arm Description

    Identical in taste and colour to the supplement juice, but with no peppermint content.

    50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day.

    Outcomes

    Primary Outcome Measures

    Systolic blood pressure
    Systolic blood pressure - measured using a digital blood pressure monitor
    Systolic blood pressure
    Systolic blood pressure - measured using a digital blood pressure monitor

    Secondary Outcome Measures

    Diastolic blood pressure
    Diastolic blood pressure - measured using a digital blood pressure monitor
    Diastolic blood pressure
    Diastolic blood pressure - measured using a digital blood pressure monitor
    Percent bodyfat
    Participants percentage composition of fat - measured using bio-electrical impedance
    Percent bodyfat
    Participants percentage composition of fat - measured using bio-electrical impedance
    Waist circumference
    Waist circumference - measured using anthropocentric tape
    Waist circumference
    Waist circumference - measured using anthropocentric tape
    Waist to hip ratio
    Ratio of waist to hip circumference - measured using anthropocentric tape
    Waist to hip ratio
    Ratio of waist to hip circumference - measured using anthropocentric tape
    Resting metabolic rate
    Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
    Resting metabolic rate
    Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
    Resting utilization of carbohydrates
    Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
    Resting utilization of carbohydrates
    Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
    Resting utilization of fats
    Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
    Resting utilization of fats
    Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
    Blood glucose
    Capillary blood glucose - mmol/L
    Blood glucose
    Capillary blood glucose - mmol/L
    Blood triglycerides
    Capillary blood triglycerides - mmol/L
    Blood triglycerides
    Capillary blood triglycerides - mmol/L
    Blood cholesterol (Total, HDL & LDL)
    Capillary blood cholesterol - mmol/L
    Blood cholesterol (Total, HDL & LDL)
    Capillary blood cholesterol - mmol/L
    Capillary blood haemoglobin
    Capillary blood haemoglobin - g/L
    Capillary blood haemoglobin
    Capillary blood haemoglobin - g/L
    Triglyceride glucose index
    Log transformed measurement of the blood glucose and blood triglyceride measures outlined above.
    Triglyceride glucose index
    Log transformed measurement of the blood glucose and blood triglyceride measures outlined above.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    September 26, 2022
    Last Updated
    July 26, 2023
    Sponsor
    University of Central Lancashire
    Collaborators
    University of Hertfordshire
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05561543
    Brief Title
    Effects of Peppermint Oil in Mild-moderate Hypertension. A Pilot Feasibility Study.
    Official Title
    Effects of Peppermint Oil in Cardiometabolic Outcomes in Participants With Mild-moderate Hypertension. A Pilot Feasibility Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2024 (Anticipated)
    Primary Completion Date
    July 1, 2025 (Anticipated)
    Study Completion Date
    September 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Central Lancashire
    Collaborators
    University of Hertfordshire

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Cardiometabolic Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Identical in taste and colour to the supplement juice, but with no peppermint content.
    Arm Title
    Peppermint oil
    Arm Type
    Experimental
    Arm Description
    50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Peppermint oil
    Intervention Description
    Peppermint oil
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Systolic blood pressure
    Description
    Systolic blood pressure - measured using a digital blood pressure monitor
    Time Frame
    Baseline
    Title
    Systolic blood pressure
    Description
    Systolic blood pressure - measured using a digital blood pressure monitor
    Time Frame
    20 days
    Secondary Outcome Measure Information:
    Title
    Diastolic blood pressure
    Description
    Diastolic blood pressure - measured using a digital blood pressure monitor
    Time Frame
    Baseline
    Title
    Diastolic blood pressure
    Description
    Diastolic blood pressure - measured using a digital blood pressure monitor
    Time Frame
    20 days
    Title
    Percent bodyfat
    Description
    Participants percentage composition of fat - measured using bio-electrical impedance
    Time Frame
    Baseline
    Title
    Percent bodyfat
    Description
    Participants percentage composition of fat - measured using bio-electrical impedance
    Time Frame
    20 days
    Title
    Waist circumference
    Description
    Waist circumference - measured using anthropocentric tape
    Time Frame
    Baseline
    Title
    Waist circumference
    Description
    Waist circumference - measured using anthropocentric tape
    Time Frame
    20 days
    Title
    Waist to hip ratio
    Description
    Ratio of waist to hip circumference - measured using anthropocentric tape
    Time Frame
    Baseline
    Title
    Waist to hip ratio
    Description
    Ratio of waist to hip circumference - measured using anthropocentric tape
    Time Frame
    20 days
    Title
    Resting metabolic rate
    Description
    Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
    Time Frame
    Baseline
    Title
    Resting metabolic rate
    Description
    Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
    Time Frame
    20 days
    Title
    Resting utilization of carbohydrates
    Description
    Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
    Time Frame
    Baseline
    Title
    Resting utilization of carbohydrates
    Description
    Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
    Time Frame
    20 days
    Title
    Resting utilization of fats
    Description
    Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
    Time Frame
    Baseline
    Title
    Resting utilization of fats
    Description
    Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
    Time Frame
    20 days
    Title
    Blood glucose
    Description
    Capillary blood glucose - mmol/L
    Time Frame
    Baseline
    Title
    Blood glucose
    Description
    Capillary blood glucose - mmol/L
    Time Frame
    20 days
    Title
    Blood triglycerides
    Description
    Capillary blood triglycerides - mmol/L
    Time Frame
    Baseline
    Title
    Blood triglycerides
    Description
    Capillary blood triglycerides - mmol/L
    Time Frame
    20 days
    Title
    Blood cholesterol (Total, HDL & LDL)
    Description
    Capillary blood cholesterol - mmol/L
    Time Frame
    Baseline
    Title
    Blood cholesterol (Total, HDL & LDL)
    Description
    Capillary blood cholesterol - mmol/L
    Time Frame
    20 days
    Title
    Capillary blood haemoglobin
    Description
    Capillary blood haemoglobin - g/L
    Time Frame
    Baseline
    Title
    Capillary blood haemoglobin
    Description
    Capillary blood haemoglobin - g/L
    Time Frame
    20 days
    Title
    Triglyceride glucose index
    Description
    Log transformed measurement of the blood glucose and blood triglyceride measures outlined above.
    Time Frame
    Baseline
    Title
    Triglyceride glucose index
    Description
    Log transformed measurement of the blood glucose and blood triglyceride measures outlined above.
    Time Frame
    20 days
    Title
    Coop-Wonka chart
    Description
    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.
    Time Frame
    Baseline
    Title
    Coop-Wonka chart
    Description
    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.
    Time Frame
    20 days
    Title
    Beck Depression Inventory
    Description
    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.
    Time Frame
    Baseline
    Title
    Beck Depression Inventory
    Description
    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.
    Time Frame
    20 days
    Title
    State Trait Anxiety Inventory
    Description
    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.
    Time Frame
    Baseline
    Title
    State Trait Anxiety Inventory
    Description
    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.
    Time Frame
    20 days
    Title
    Insomnia Severity Index
    Description
    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.
    Time Frame
    Baseline
    Title
    Insomnia Severity Index
    Description
    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.
    Time Frame
    20 days
    Title
    Pittsburgh Sleep Quality Index
    Description
    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.
    Time Frame
    Baseline
    Title
    Pittsburgh Sleep Quality Index
    Description
    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.
    Time Frame
    20 days
    Title
    Epworth Sleepiness Scale
    Description
    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.
    Time Frame
    Baseline
    Title
    Epworth Sleepiness Scale
    Description
    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.
    Time Frame
    20 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meet 3 of 5 criteria for Metabolic Syndrome based on National Cholesterol Education Program-Adult Treatment Panel III guidelines: Waist Circumference: >102cm (men), >88cm (women) Fasting Triglycerides: ≥1.69 mmol.L-1 Fasting High Density Lipoprotein: <1.03 mmol.L-1 (men), <1.29 mmol.L-1 (women) Blood Pressure: ≥130 mmHg SBP or ≥85 mmHg DBP 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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jonathan Sinclair, DSc
    Phone
    +447875651533
    Email
    jksinclair@uclan.ac.uk

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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