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| Name | Class |
|---|---|
| University of Hertfordshire | OTHER |
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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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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peppermint oil | Dietary Supplement | Peppermint oil |
| |
| Placebo |
| 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 |
|---|---|---|
| Diastolic blood pressure | Diastolic blood pressure - measured using a digital blood pressure monitor | Baseline |
| Diastolic blood pressure | Diastolic blood pressure - measured using a digital blood pressure monitor |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Central Lancashire | Preston | Lancashire | PR4 0PE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42024666 | Derived | Sinclair J, Sant B, Du X, Shadwell G, Dillon S, Butters B, Bottoms L. Effects of peppermint (Mentha x piperita L.) oil on cardiometabolic outcomes in patients with pre- and stage 1 hypertension: A placebo randomized controlled trial. PLoS One. 2026 Apr 23;21(4):e0344538. doi: 10.1371/journal.pone.0344538. eCollection 2026. | |
| 40333716 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C015424 | peppermint oil |
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| Other |
Placebo |
|
| 20 days |
| Percent bodyfat and fat mass | Participants percentage composition of fat - measured using bio-electrical impedance | Baseline |
| Percent bodyfat and fat mass | Participants percentage composition of fat - measured using bio-electrical impedance | 20 days |
| Waist circumference | Waist circumference - measured using anthropocentric tape | Baseline |
| Waist circumference | Waist circumference - measured using anthropocentric tape | 20 days |
| Waist to hip ratio | Ratio of waist to hip circumference - measured using anthropocentric tape | Baseline |
| Waist to hip ratio | Ratio of waist to hip circumference - measured using anthropocentric tape | 20 days |
| Blood glucose | Capillary blood glucose - mmol/L | Baseline |
| Blood glucose | Capillary blood glucose - mmol/L | 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 |
| Total and HDL cholesterol ratio | Ratio of total cholesterol to HDL cholesterol | Baseline |
| Total and HDL cholesterol ratio | Ratio of total cholesterol to HDL cholesterol | 20 days |
| LDL and HDL cholesterol ratio | Ratio of LDL to HDL cholesterol | Baseline |
| Total and HDL cholesterol ratio | Ratio of LDL to HDL cholesterol | 20 days |
| Triglyceride glucose index | Log transformed measurement of the blood glucose and blood triglyceride measures outlined above. | Baseline |
| Triglyceride glucose index | Log transformed measurement of the blood glucose and blood triglyceride measures outlined above. | 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 |
| 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. | 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. | 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. | Baseline |
| 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 |
| 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 |
| Sinclair J, Du X, Shadwell G, Dillon S, Butters B, Bottoms L. Effects of peppermint (Mentha piperita L.) oil in cardiometabolic outcomes in participants with pre and stage 1 hypertension: Protocol for a placebo randomized controlled trial. PLoS One. 2025 May 7;20(5):e0321986. doi: 10.1371/journal.pone.0321986. eCollection 2025. |