Clinical Study With Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Variations of lipid profile
研究概览
简要总结
To evaluate the effects of a nutraceutical containing Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol on lipid profile
详细描述
To evaluate the effects of a nutraceutical containing Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol compared to placebo on lipid profile in patients with LDL cholesterol > 115 and < 190 mg/dl.Patients were allocated to receive 1 or 2 tablets of the nutraceutical for 12 weeks.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LDL Cholesterol > 115 mg/dl and < 190 mg/dl
- •primary prevention
排除标准
- •patients with neoplastic and liver diseases, renal failure and diabetes mellitus
- •pregnant or breastfeeding women
- •hypersensitivity to any of the ingredients
- •therapy with lipid-lowering drugs
研究组 & 干预措施
1 tablet
干预措施: Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol (Dietary Supplement)
2 tablets
干预措施: Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol (Dietary Supplement)
结局指标
主要结局
Variations of lipid profile
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Giuseppe Derosa
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia