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临床试验/NCT05071833
NCT05071833已完成不适用

Effects of Oral Peppermint Supplementation on Cardiometabolic Parameters

University of Central Lancashire1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Systolic blood pressure

研究概览

简要总结

Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. Previous non-randomized interventions have shown that oral peppermint may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.

Therefore, the primary purpose of the proposed investigation is to test the ability of oral peppermint oil supplementation to improve cardiometabolic parameters in healthy individuals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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
是

入选标准

  • •Between 18 & 65 years
  • •Non-smoker
  • •BMI < 30
  • •Able to give informed consent

排除标准

  • •Pregnancy
  • •Diabetes or any other metabolic/ uncontrolled hypertensive conditions
  • •Food allergies to peppermint
  • •Habitual consumption of peppermint
  • •Not regularly taking medication or antioxidant supplements

研究组 & 干预措施

Placebo

Placebo Comparator

Identical in taste and colour to the supplement juice, but with no peppermint content.

干预措施: Placebo (Other)

Peppermint oil

Experimental

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: 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)
  • Resting utilization of fats(20 days)
  • Blood glucose(20 days)
  • Triglyceride glucose index(20 days)
  • Blood triglycerides(20 days)
  • Percent bodyfat(20 days)
  • Waist to hip ratio(Baseline)
  • Resting metabolic rate(20 days)
  • Resting utilization of carbohydrates(Baseline)
  • Blood cholesterol (Total, HDL & LDL)(20 days)
  • Blood haemoglobin(20 days)
  • Coop-Wonka chart(20 days)
  • Beck Depression Inventory(20 days)
  • State Trait Anxiety Inventory(20 days)
  • Insomnia Severity Index(Baseline)
  • Pittsburgh Sleep Quality Index(20 days)
  • Epworth Sleepiness Scale(20 days)
  • Percent bodyfat(Baseline)
  • Waist to hip ratio(20 days)
  • Resting metabolic rate(Baseline)
  • Resting utilization of carbohydrates(20 days)
  • Blood glucose(Baseline)
  • Resting utilization of fats(Baseline)
  • Triglyceride glucose index(Baseline)
  • Blood triglycerides(Baseline)
  • Blood cholesterol (Total, HDL & LDL)(Baseline)
  • Blood haemoglobin(Baseline)
  • Coop-Wonka chart(Baseline)
  • Beck Depression Inventory(Baseline)
  • State Trait Anxiety Inventory(Baseline)
  • Insomnia Severity Index(20 days)
  • Pittsburgh Sleep Quality Index(Baseline)
  • Epworth Sleepiness Scale(Baseline)
  • Diastolic blood pressure(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Sinclair

Professor

University of Central Lancashire

研究点 (1)

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