Clinical trial NCT05561543: Effects of Peppermint Oil in Mild-moderate Hypertension.
Official title: Effects of Peppermint Oil in Cardiometabolic Outcomes in Participants With Mild-moderate Hypertension.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
Collaborators: name: University of Hertfordshire
First posted: 2022-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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

Primary outcomes:
measure: Systolic blood pressure
timeFrame: Baseline
measure: Systolic blood pressure
timeFrame: 20 days
Secondary outcomes:
measure: Diastolic blood pressure
timeFrame: Baseline
measure: Diastolic blood pressure
timeFrame: 20 days
measure: Percent bodyfat and fat mass
timeFrame: Baseline
measure: Percent bodyfat and fat mass
timeFrame: 20 days
measure: Waist circumference
timeFrame: Baseline
measure: Waist circumference
timeFrame: 20 days
measure: Waist to hip ratio
timeFrame: Baseline
measure: Waist to hip ratio
timeFrame: 20 days
measure: Blood glucose
timeFrame: Baseline
measure: Blood glucose
timeFrame: 20 days
measure: Blood triglycerides
timeFrame: Baseline
measure: Blood triglycerides
timeFrame: 20 days
measure: Blood cholesterol (Total, HDL & LDL)
timeFrame: Baseline
measure: Blood cholesterol (Total, HDL & LDL)
timeFrame: 20 days
measure: Total and HDL cholesterol ratio
timeFrame: Baseline
measure: Total and HDL cholesterol ratio
timeFrame: 20 days
measure: LDL and HDL cholesterol ratio
timeFrame: Baseline
measure: Total and HDL cholesterol ratio
timeFrame: 20 days
measure: Triglyceride glucose index
timeFrame: Baseline
measure: Triglyceride glucose index
timeFrame: 20 days
measure: Coop-Wonka chart
timeFrame: Baseline
measure: Coop-Wonka chart
timeFrame: 20 days
measure: Beck Depression Inventory
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: 20 days
measure: State Trait Anxiety Inventory
timeFrame: Baseline
measure: State Trait Anxiety Inventory
timeFrame: 20 days
measure: Insomnia Severity Index
timeFrame: Baseline
measure: Insomnia Severity Index
timeFrame: 20 days
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: 20 days
measure: Epworth Sleepiness Scale
timeFrame: Baseline
measure: Epworth Sleepiness Scale
timeFrame: 20 days
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: University of Central Lancashire
state: Lancashire
Study officials:
References: