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 with diabetes mellitus and/ or coronary heart disease
- •Pregnant and lactating women
- •Allergy to peppermint
- •Habitual consumption of peppermint products
- •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
研究组 & 干预措施
Placebo
Identical in taste and colour to the supplement juice, but with no peppermint content.
干预措施: Placebo (Other)
Peppermint oil
50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day.
干预措施: Peppermint oil (Dietary Supplement)
结局指标
主要结局
Systolic blood pressure
时间窗: Baseline
Systolic blood pressure - measured using a digital blood pressure monitor
Systolic blood pressure
时间窗: 20 days
Systolic blood pressure - measured using a digital blood pressure monitor
次要结局
- State Trait Anxiety Inventory(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)
- Diastolic blood pressure(20 days)
- LDL and HDL cholesterol ratio(Baseline)
- Triglyceride glucose index(20 days)
- Beck Depression Inventory(20 days)
- Coop-Wonka chart(20 days)
- Insomnia Severity Index(20 days)
- Pittsburgh Sleep Quality Index(20 days)
- Epworth Sleepiness Scale(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)
研究者
Jonathan Sinclair
Professor
University of Central Lancashire