跳至主要内容
临床试验/NCT05210218
NCT05210218已完成不适用

Effect on Weight Loss of an Oral Association of Cinnamon Bark (Cinnamomum Cassia) and Withania Somnifera in Adult Patients With Overweight or Obesity: a Randomized, Prospective, Placebo-controlled, Multicenter, Cross-over, Pilot Study

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
weight change

研究概览

简要总结

With the prevalence of obesity soaring and the absence of an effective and safe treatment that is low-cost and always feasible, the use of food supplements has gained attention for the potential benefits in the absence of significant safety concerns. Cinnamon (CC) and Withania somnifera (WS) are plant-based supplements reported to be effective in improving metabolic health and body composition, the first mainly acting on insulin resistance and the second on energy expenditure and leptin resistance, as shown in preclinical and some clinical studies. Their association, possibly synergistic leveraging different mechanisms of action, has never been studied.

This was a double-blind placebo-controlled study. Patients with overweight or obesity were prescribed a mildly hypocaloric diet with CC 300 mg plus WS 150 mg tid for 4 weeks in a cross over design and anthropometric parameters together with safety outcomes were collected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age range: 25-75 years
  • overweight or obesity (BMI range: 26-35)

排除标准

  • heart failure
  • congenital cardiomyopathies
  • episodes of tachy/brady-arrythmias
  • acute myocardial infarction within 3 months from the enrollment
  • inability or unwillingness to provide informed consent
  • pregnancy

结局指标

主要结局

weight change

时间窗: at baseline and at every follow up visit, through study completion, an average of 10 weeks

body mass change in kg

次要结局

  • waist circumference change(at baseline and at every follow up visit through study completion, an average of 10 weeks)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lucio Gnessi

Full Professor MD PhD

University of Roma La Sapienza

研究点 (2)

Loading locations...

相似试验