Effects of Peppermint Oil in Pre-metabolic Syndrome.
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 metabolic diseases are leading causes of morbidity and mortality worldwide; therefore, the development of effective preventive interventions is paramount. Pre-metabolic syndrome, characterised by the presence of cardiometabolic risk factors without meeting the full diagnostic criteria for metabolic syndrome, may represent an important opportunity for early intervention. Dietary interventions are particularly attractive because they may carry fewer risks and impose a lower financial burden than pharmacological treatments. Our previous randomised trial showed that oral peppermint oil supplementation improved systolic blood pressure and selected blood lipid parameters in healthy adults. However, no placebo-controlled randomised trial has examined the effects of peppermint oil supplementation in adults with pre-metabolic syndrome.
Therefore, the primary purpose of the proposed investigation is to determine whether oral peppermint oil supplementation improves cardiometabolic parameters in adults with pre-metabolic syndrome.
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 18-65 years. Meet two of the five metabolic syndrome criteria. Not taking prescribed medication specifically intended to manage blood pressure, blood glucose or blood lipids.
- •Able 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 six 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 hypertension-related target-organ damage requiring specialist management.
- •Pregnant or lactating. Allergy or known intolerance to peppermint or any ingredient contained in the intervention or placebo.
- •Habitual consumption of peppermint products. Regular consumption of antioxidant or other dietary supplements likely to influence cardiometabolic outcomes.
- •Body mass index greater than 40.0 kg/m². Current enrolment in another clinical trial or use of another intervention or therapy likely to influence the study outcomes.
- •Any condition likely to compromise informed consent, protocol compliance or outcome assessment, including severe psychiatric illness, cognitive impairment, or active substance or alcohol misuse.
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 (Radiation)
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
- Diastolic blood pressure(Baseline)
- Diastolic blood pressure(20 days)
- Percent bodyfat and fat mass(Baseline)
- Percent bodyfat and fat mass(20 days)
- Waist circumference(Baseline)
- Waist circumference(20 days)
- Waist to hip ratio(Baseline)
- Waist to hip ratio(20 days)
- Blood glucose(Baseline)
- Blood glucose(20 days)
- Blood triglycerides(Baseline)
- Blood triglycerides(20 days)
- Blood cholesterol (Total, HDL & LDL)(Baseline)
- Blood cholesterol (Total, HDL & LDL)(20 days)
- Total and HDL cholesterol ratio(Baseline)
- Total and HDL cholesterol ratio(20 days)
- LDL and HDL cholesterol ratio(Baseline)
- LDL and HDL cholesterol ratio(20 days)
- Triglyceride glucose index(Baseline)
- Triglyceride glucose index(20 days)
- Coop-Wonka chart(Baseline)
- Coop-Wonka chart(20 days)
- Beck Depression Inventory(Baseline)
- Beck Depression Inventory(20 days)
- State Trait Anxiety Inventory(Baseline)
- State Trait Anxiety Inventory(20 days)
- Pittsburgh Sleep Quality Index(Baseline)
- Pittsburgh Sleep Quality Index(20 days)
- Epworth Sleepiness Scale(Baseline)
- Epworth Sleepiness Scale(20 days)
- Insomnia Severity Index(Baseline)
- Insomnia Severity Index(20 days)
研究者
Jonathan Sinclair
Professor
University of Central Lancashire