Effects of Berberine Supplementation on Cardiometabolic Parameters
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Blood triglycerides
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. It has been postulated that Berberine may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.
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 berberine
- •Habitual consumption of berberine
- •Not regularly taking medication or antioxidant supplements
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
Berberine tablets 500mg 2 x p/d
干预措施: Berberine (Dietary Supplement)
结局指标
主要结局
Blood triglycerides
时间窗: Baseline
Capillary blood triglycerides - mmol/L
Blood triglycerides
时间窗: 20-days
Capillary blood triglycerides - mmol/L
次要结局
- Systolic blood pressure(Baseline)
- Systolic blood pressure(20-days)
- Diastolic blood pressure(Baseline)
- Diastolic blood pressure(20-days)
- Percent bodyfat(Baseline)
- Percent bodyfat(20-days)
- Waist to hip ratio(Baseline)
- Waist to hip ratio(20-days)
- Blood glucose(Baseline)
- Blood glucose(20-days)
- Triglyceride glucose index(Baseline)
- Triglyceride glucose index(20-days)
- Blood cholesterol - Total(Baseline)
- Blood cholesterol - Total(20-days)
- Blood cholesterol - LDL(Baseline)
- Blood cholesterol - LDL(20-days)
- Blood cholesterol - HDL(Baseline)
- Blood cholesterol - HDL(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)
- Insomnia Severity Index(Baseline)
- Insomnia Severity Index(20-days)
- Pittsburgh Sleep Quality Index(Baseline)
- Pittsburgh Sleep Quality Index(20-days)
- Epworth Sleepiness Scale(Baseline)
- Epworth Sleepiness Scale(20-days)
研究者
Jonathan Sinclair
Professor
University of Central Lancashire