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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Identical in taste and colour to the supplement juice, but with no peppermint content. |
|
| Peppermint oil | Experimental | 50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peppermint oil. | Dietary Supplement | Peppermint oil. |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonathan Sinclair | Preston | Lancashire | PR4 0PE | United Kingdom |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C015424 | peppermint oil |
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| Placebo |
| Other |
Placebo |
|
| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |