跳至主要内容
临床试验/NCT03019263
NCT03019263已完成不适用

Nutraceutical Intervention With Berberine, Chlorogenic Acid and Tocotrienols for Menopause-associated Dyslipidemia: a Randomized, Controlled Trial

Fondazione IRCCS Policlinico San Matteo di Pavia2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2017年3月31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
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

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

Experimental

Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid

干预措施: Nutraceutical (Dietary Supplement)

Control

Active Comparator

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

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Riccardo Caccialanza

Principal Investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (2)

Loading locations...

相似试验