Nutraceutical Intervention With Berberine, Chlorogenic Acid and Tocotrienols for Menopause-associated Dyslipidemia: a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- LDL cholesterol
研究概览
简要总结
Menopause is usually associated with an increase in body weight, a change in body composition and fat distribution and a large number of cardio-metabolic changes, such as hypertension, reduction of insulin-sensitivity and dyslipidaemia. The first-line strategy for these complications is the modification of dietary habits and lifestyle in terms of physical activity. Besides, there is also a growing interest in complementary therapies (i.e. nutraceuticals) that can be used alone or in combination to achieve more consistent results. In this context, preliminary evidence supports the potential role of some compounds of vegetal origin such as berberine, chlorogenic acid and tocotrienols. However, in support of their use, the evidence from good quality trials is limited.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •LDL cholesterol >100 mg/dL
- •Written informed consent available
排除标准
- •Use of any drug affecting blood lipids
- •Hormone replacement therapy
- •Adherence to a weigh loss diet in the previous 6 months
- •Cancer diagnosis
- •Known thyroid, liver, renal or muscle diseases
- •Any medical or surgical condition which could lead to an inconstant adhesion to the protocol
研究组 & 干预措施
Nutraceutical
Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
干预措施: Nutraceutical (Dietary Supplement)
Control
Nutritional counseling
干预措施: Control (Other)
结局指标
主要结局
LDL cholesterol
时间窗: 3 months
LDL cholesterol
次要结局
- Total cholesterol(3 months)
- HDL cholesterol(3 months)
- Blood glucose(3 months)
- Serum Insulin(3 months)
- Body weight(3 months)
- Insulin resistance(3 months)
- Fat distribution(3 months)
- Fat Mass(3 months)
- Quality of life(3 months)
- Menopausal symptoms(3 months)
研究者
Riccardo Caccialanza
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
