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Completed

NCT Number: NCT05561543

Effects of Peppermint Oil in 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Lancashire

Preston, Lancashire, PR4 0PE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

peppermint oil

Dietary Supplement

Peppermint oil

Placebo

Other

Placebo

Primary outcomes

  1. Systolic blood pressure

    Time frame: Baseline

    Systolic blood pressure - measured using a digital blood pressure monitor

  2. Systolic blood pressure

    Time frame: 20 days

    Systolic blood pressure - measured using a digital blood pressure monitor

Secondary outcomes

  1. Diastolic blood pressure

    Time frame: Baseline

    Diastolic blood pressure - measured using a digital blood pressure monitor

  2. Diastolic blood pressure

    Time frame: 20 days

    Diastolic blood pressure - measured using a digital blood pressure monitor

  3. Percent bodyfat and fat mass

    Time frame: Baseline

    Participants percentage composition of fat - measured using bio-electrical impedance

  4. Percent bodyfat and fat mass

    Time frame: 20 days

    Participants percentage composition of fat - measured using bio-electrical impedance

  5. Waist circumference

    Time frame: Baseline

    Waist circumference - measured using anthropocentric tape

  6. Waist circumference

    Time frame: 20 days

    Waist circumference - measured using anthropocentric tape

  7. Waist to hip ratio

    Time frame: Baseline

    Ratio of waist to hip circumference - measured using anthropocentric tape

  8. Waist to hip ratio

    Time frame: 20 days

    Ratio of waist to hip circumference - measured using anthropocentric tape

  9. Blood glucose

    Time frame: Baseline

    Capillary blood glucose - mmol/L

  10. Blood glucose

    Time frame: 20 days

    Capillary blood glucose - mmol/L

  11. Blood triglycerides

    Time frame: Baseline

    Capillary blood triglycerides - mmol/L

  12. Blood triglycerides

    Time frame: 20 days

    Capillary blood triglycerides - mmol/L

  13. Blood cholesterol (Total, HDL & LDL)

    Time frame: Baseline

    Capillary blood cholesterol - mmol/L

  14. Blood cholesterol (Total, HDL & LDL)

    Time frame: 20 days

    Capillary blood cholesterol - mmol/L

  15. Total and HDL cholesterol ratio

    Time frame: Baseline

    Ratio of total cholesterol to HDL cholesterol

  16. Total and HDL cholesterol ratio

    Time frame: 20 days

    Ratio of total cholesterol to HDL cholesterol

  17. LDL and HDL cholesterol ratio

    Time frame: Baseline

    Ratio of LDL to HDL cholesterol

  18. Total and HDL cholesterol ratio

    Time frame: 20 days

    Ratio of LDL to HDL cholesterol

  19. Triglyceride glucose index

    Time frame: Baseline

    Log transformed measurement of the blood glucose and blood triglyceride measures outlined above.

  20. Triglyceride glucose index

    Time frame: 20 days

    Log transformed measurement of the blood glucose and blood triglyceride measures outlined above.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

Sponsors and collaborators

Lead sponsor

University of Central Lancashire

Other

Collaborators

  • University of Hertfordshire

Registry information

Official study title

Effects of Peppermint Oil in Cardiometabolic Outcomes in Participants With Mild-moderate Hypertension.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 30, 2022
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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