Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients. Single-center, Randomized, Double-blind Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Variation of LDL cholesterol
研究概览
简要总结
The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl.
详细描述
The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight or obese subjects [according to body mass index (BMI)]
- •Fasting plasma glucose value between 100 and 125 mg/dl, with impaired fasting glucose or impaired glucose tolerance confirmed with oral glucose tolerance test (OGTT)
- •Total cholesterol values ≥ 200 mg/dl
排除标准
- •Patients with neoplastic and liver diseases, renal failure
- •Patients with type 1 or 2 diabetes mellitus
- •Pregnant or breastfeeding women
- •Hypersensitivity to any of the ingredients
- •Therapy with lipid-lowering drugs
- •Use of products containing red yeast rice
结局指标
主要结局
Variation of LDL cholesterol
时间窗: 12 months
Reduction of LDL-cholesterol after the nutraceutical or placebo intake
次要结局
- Change in glycemic status(12 months)
- Variation of lipid profile(12 months)
研究者
Giuseppe Derosa
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia