Hypertension
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPeppermint oil
Peppermint oil
OTHERPlacebo
Placebo
Sponsors
University of Hertfordshire
University of Central Lancashire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged from 18-65 years 2. Systolic blood pressure 120 to 139 mmHg 3. Not taking prescribed medicine for blood pressure management 4. have the ability to complete written questionnaires independently 5. Able to provide informed consent
Exclusion criteria
1. diagnosed diabetes mellitus 2. 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 3. known or suspected secondary hypertension, including renal, renovascular, or endocrine causes 4. known clinically significant renal impairment or severe hepatic disease 5. evidence or history of severe hypertension related target organ damage requiring specialist management 6. pregnant or lactating women 7. allergy to peppermint 8. habitual consumption of peppermint products 9. regular consumption of antioxidant supplements 10. body mass index larger than 40.0 kg/m² 11. current enrolment in other clinical trials or use of other external therapies likely to influence outcomes 12. condition(s) likely to compromise informed consent, protocol compliance, or outcome assessment, including severe psychiatric illness, cognitive impairment, or active substance or alcohol misuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | Baseline | Systolic blood pressure - measured using a digital blood pressure monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent bodyfat and fat mass | Baseline | Participants percentage composition of fat - measured using bio-electrical impedance |
| Waist circumference | Baseline | Waist circumference - measured using anthropocentric tape |
| Waist to hip ratio | Baseline | Ratio of waist to hip circumference - measured using anthropocentric tape |
| Blood glucose | Baseline | Capillary blood glucose - mmol/L |
| Blood triglycerides | Baseline | Capillary blood triglycerides - mmol/L |
| Blood cholesterol (Total, HDL & LDL) | Baseline | Capillary blood cholesterol - mmol/L |
| Total and HDL cholesterol ratio | Baseline | Ratio of total cholesterol to HDL cholesterol |
| Diastolic blood pressure | Baseline | Diastolic blood pressure - measured using a digital blood pressure monitor |
| Triglyceride glucose index | Baseline | Log transformed measurement of the blood glucose and blood triglyceride measures outlined above. |
| Coop-Wonka chart | 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. |
| Beck Depression Inventory | 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. |
| State Trait Anxiety Inventory | 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. |
| Insomnia Severity Index | 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. |
| Pittsburgh Sleep Quality Index | 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. |
| Epworth Sleepiness Scale | 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. |
| LDL and HDL cholesterol ratio | Baseline | Ratio of LDL to HDL cholesterol |
Countries
United Kingdom
Outcome results
None listed