Effects of Peppermint Oil in Cardiometabolic Outcomes in Participants With Mild-moderate Hypertension.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Systolic blood pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18-65 years
- •Systolic blood pressure 120 to 139 mmHg
- •Not taking prescribed medicine for blood pressure management
- •have the ability to complete written questionnaires independently
- •Able to provide informed consent
排除标准
- •diagnosed diabetes mellitus
- •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
- •known or suspected secondary hypertension, including renal, renovascular, or endocrine causes
- •known clinically significant renal impairment or severe hepatic disease
- •evidence or history of severe hypertension related target organ damage requiring specialist management
- •pregnant or lactating women
- •allergy to peppermint
- •habitual consumption of peppermint products
- •regular consumption of antioxidant supplements
- •body mass index larger than 40.0 kg/m²
- •current enrolment in other clinical trials or use of other external therapies likely to influence outcomes
- •condition(s) likely to compromise informed consent, protocol compliance, or outcome assessment, including severe psychiatric illness, cognitive impairment, or active substance or alcohol misuse.
结局指标
主要结局
Systolic blood pressure
时间窗: 20 days
Systolic blood pressure - measured using a digital blood pressure monitor
Systolic blood pressure
时间窗: Baseline
Systolic blood pressure - measured using a digital blood pressure monitor
次要结局
- Diastolic blood pressure(20 days)
- LDL and HDL cholesterol ratio(Baseline)
- Triglyceride glucose index(20 days)
- Beck Depression Inventory(20 days)
- Percent bodyfat and fat mass(20 days)
- Waist circumference(20 days)
- Waist to hip ratio(20 days)
- Blood glucose(20 days)
- Blood triglycerides(20 days)
- Blood cholesterol (Total, HDL & LDL)(20 days)
- Coop-Wonka chart(20 days)
- State Trait Anxiety Inventory(20 days)
- Insomnia Severity Index(20 days)
- Pittsburgh Sleep Quality Index(20 days)
- Epworth Sleepiness Scale(20 days)
- Total and HDL cholesterol ratio(20 days)
- Diastolic blood pressure(Baseline)
- Percent bodyfat and fat mass(Baseline)
- Waist circumference(Baseline)
- Waist to hip ratio(Baseline)
- Blood glucose(Baseline)
- Blood triglycerides(Baseline)
- Blood cholesterol (Total, HDL & LDL)(Baseline)
- Total and HDL cholesterol ratio(Baseline)
- Triglyceride glucose index(Baseline)
- Coop-Wonka chart(Baseline)
- Beck Depression Inventory(Baseline)
- State Trait Anxiety Inventory(Baseline)
- Insomnia Severity Index(Baseline)
- Pittsburgh Sleep Quality Index(Baseline)
- Epworth Sleepiness Scale(Baseline)
研究者
Jonathan Sinclair
Professor
University of Central Lancashire