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
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
- 否
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
Lucio Gnessi
Full Professor MD PhD
University of Roma La Sapienza
