Effects of Peppermint Oil in Mild-moderate Hypertension.

Not Applicable

Recruiting

• Conditions: Hypertension
• Interventions: Other: Placebo; Dietary Supplement: Peppermint oil

• Registration Number: NCT05561543
• Lead Sponsor: University of Central Lancashire

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-30
• Study Start: 2024-01-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-13
• Primary Completion: 2025-07-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

1. Diagnosed with diabetes mellitus and/ or coronary heart disease
2. Pregnant and lactating women
3. Allergy to peppermint
4. Habitual consumption of peppermint products
5. Regular consumption of antioxidant supplements

(5) Body mass index larger than 40.0 kg/m2 (6) Current enrolment in other clinical trials of other external therapies

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Identical in taste and colour to the supplement juice, but with no peppermint content.
Peppermint oil	Peppermint oil	50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day.

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure	20 days	Systolic blood pressure - measured using a digital blood pressure monitor

Secondary Outcome Measures

Name	Time	Method
Diastolic blood pressure	20 days	Diastolic blood pressure - measured using a digital blood pressure monitor
LDL and HDL cholesterol ratio	Baseline	Ratio of LDL to HDL cholesterol
Triglyceride glucose index	20 days	Log transformed measurement of the blood glucose and blood triglyceride measures outlined above.
Beck Depression Inventory	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.
Percent bodyfat and fat mass	20 days	Participants percentage composition of fat - measured using bio-electrical impedance
Waist circumference	20 days	Waist circumference - measured using anthropocentric tape
Waist to hip ratio	20 days	Ratio of waist to hip circumference - measured using anthropocentric tape
Blood glucose	20 days	Capillary blood glucose - mmol/L
Blood triglycerides	20 days	Capillary blood triglycerides - mmol/L
Blood cholesterol (Total, HDL & LDL)	20 days	Capillary blood cholesterol - mmol/L
Total and HDL cholesterol ratio	20 days	Ratio of LDL to HDL cholesterol
Coop-Wonka chart	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.
State Trait Anxiety Inventory	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.
Insomnia Severity Index	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.
Pittsburgh Sleep Quality Index	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.
Epworth Sleepiness Scale	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.

Trial Locations

Locations (1)

University of Central Lancashire; 🇬🇧 Preston, Lancashire, United Kingdom