Effects of Peppermint Oil in Cardiometabolic Outcomes

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Oral Peppermint Supplementation on Cardiometabolic Parameters

Conditions
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Cardiometabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Peppermint oil.
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Identical in taste and colour to the supplement juice, but with no peppermint content. | Other: Placebo<br>* Placebo<br>|
| Experimental: Peppermint oil<br>50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day. | Dietary Supplement: Peppermint oil.<br>* Peppermint oil.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Systolic blood pressure - measured using a digital blood pressure monitor | Baseline | 
| Systolic blood pressure | Systolic blood pressure - measured using a digital blood pressure monitor | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent bodyfat | Participants percentage composition of fat - measured using bio-electrical impedance | Baseline | 
| Percent bodyfat | Participants percentage composition of fat - measured using bio-electrical impedance | 20 days | 
| Waist to hip ratio | Ratio of waist to hip circumference - measured using anthropocentric tape | 20 days | 
| Waist to hip ratio | Ratio of waist to hip circumference - measured using anthropocentric tape | Baseline | 
| Resting metabolic rate | Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry. | Baseline | 
| Resting metabolic rate | Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry. | 20 days | 
| Resting utilization of carbohydrates | Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry. | 20 days | 
| Resting utilization of carbohydrates | Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry. | Baseline | 
| Resting utilization of fats | Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry. | Baseline | 
| Resting utilization of fats | Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry. | 20 days | 
| Blood glucose | Capillary blood glucose - mmol/L | Baseline | 
| Blood glucose | Capillary blood glucose - mmol/L | 20 days | 
| Triglyceride glucose index | Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2) | Baseline | 
| Triglyceride glucose index | Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2) | 20 days | 
| Blood triglycerides | Capillary blood triglycerides - mmol/L | Baseline | 
| Blood triglycerides | Capillary blood triglycerides - mmol/L | 20 days | 
| Blood cholesterol (Total, HDL & LDL) | Capillary blood cholesterol - mmol/L | Baseline | 
| Blood cholesterol (Total, HDL & LDL) | Capillary blood cholesterol - mmol/L | 20 days | 
| Blood haemoglobin | Capillary blood haemoglobin - g/L | Baseline | 
| Blood haemoglobin | Capillary blood haemoglobin - g/L | 20 days | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Diastolic blood pressure | Systolic and diastolic blood pressure - measured using a digital blood pressure monitor | Baseline | 
| Diastolic blood pressure | Systolic and diastolic blood pressure - measured using a digital blood pressure monitor | 20 days |