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Completed

NCT Number: NCT05071833

Effects of Peppermint Oil in Cardiometabolic Outcomes

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.

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Key information

Conditions

Cardiometabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jonathan Sinclair

Preston, Lancashire, PR4 0PE, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

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

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. Percent bodyfat

    Time frame: Baseline

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

  2. Percent bodyfat

    Time frame: 20 days

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

  3. Waist to hip ratio

    Time frame: 20 days

    Ratio of waist to hip circumference - measured using anthropocentric tape

  4. Waist to hip ratio

    Time frame: Baseline

    Ratio of waist to hip circumference - measured using anthropocentric tape

  5. Resting metabolic rate

    Time frame: Baseline

    Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.

  6. Resting metabolic rate

    Time frame: 20 days

    Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.

  7. Resting utilization of carbohydrates

    Time frame: 20 days

    Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.

  8. Resting utilization of carbohydrates

    Time frame: Baseline

    Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.

  9. Resting utilization of fats

    Time frame: Baseline

    Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.

  10. Resting utilization of fats

    Time frame: 20 days

    Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.

  11. Blood glucose

    Time frame: Baseline

    Capillary blood glucose - mmol/L

  12. Blood glucose

    Time frame: 20 days

    Capillary blood glucose - mmol/L

  13. Triglyceride glucose index

    Time frame: Baseline

    Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)

  14. Triglyceride glucose index

    Time frame: 20 days

    Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)

  15. Blood triglycerides

    Time frame: Baseline

    Capillary blood triglycerides - mmol/L

  16. Blood triglycerides

    Time frame: 20 days

    Capillary blood triglycerides - mmol/L

  17. Blood cholesterol (Total, HDL & LDL)

    Time frame: Baseline

    Capillary blood cholesterol - mmol/L

  18. Blood cholesterol (Total, HDL & LDL)

    Time frame: 20 days

    Capillary blood cholesterol - mmol/L

  19. Blood haemoglobin

    Time frame: Baseline

    Capillary blood haemoglobin - g/L

  20. Blood haemoglobin

    Time frame: 20 days

    Capillary blood haemoglobin - g/L

  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. 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.

  23. 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.

  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: 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.

  28. 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.

  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.

  33. Diastolic blood pressure

    Time frame: Baseline

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

  34. Diastolic blood pressure

    Time frame: 20 days

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

Sponsors and collaborators

Lead sponsor

University of Central Lancashire

Other

Registry information

Official study title

Effects of Oral Peppermint Supplementation on Cardiometabolic Parameters

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2021
Registry last updated
Mar 31, 2023

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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