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临床试验/NCT04692792
NCT04692792已完成不适用

Efficacy Evaluation of Dai Dai Flower on Body Weight

TCI Co., Ltd.2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年1月4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
TCI Co., Ltd.
入组人数
50
试验地点
2
主要终点
The change of body weight

研究概览

简要总结

To assess the Dai Dai flower extract on body weight control

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy male or female aged between 20 and 60 years old
  • Body mass index (BMI) ≥ 24 (kg/m^2) or body fat mass ≥ 25%

排除标准

  • Pregnant or breastfeeding woman
  • Implementation in weight loss programs, consumption drugs or supplements for weight control before 3 months of this study
  • Participate weight control or fat loss human studies before 3 months of this study
  • History of cardiovascular disease, liver disease, kidney disease, endocrine disease, or other major organic diseases (according to subjects reporting).
  • Person who has received major surgery or bariatric surgery (according to medical history).
  • Person who has received constant drug use.
  • People with mental illness

结局指标

主要结局

The change of body weight

时间窗: Change from Baseline body weight at 8 weeks

The body weight (kg) was assessed by InBody.

The change of BMI

时间窗: Change from Baseline BMI at 8 weeks

The BMI was assessed by InBody.

次要结局

  • The change of IFN-γ(Change from Baseline IFN-γ at 8 weeks)
  • The change of IL-2(Change from Baseline IL-2 at 8 weeks)
  • The change of IL-1beta(Change from Baseline IL-1beta at 8 weeks)
  • The change of leptin(Change from Baseline leptin at 8 weeks)
  • The change of body fat mass(Change from Baseline body fat mass at 8 weeks)
  • The change of visceral fat mass(Change from Baseline visceral fat mass at 8 weeks)
  • The change of waist-hip ratio(Change from Baseline waist-hip ratio at 8 weeks)
  • The change of basal metabolic rate(Change from Baseline basal metabolic rate at 8 weeks)
  • The change of AST(Change from Baseline AST at 8 weeks)
  • The change of ALT(Change from Baseline ALT at 8 weeks)
  • The change of Creatinine(Change from Baseline creatinine at 8 weeks)
  • The change of BUN(Change from Baseline BUN at 8 weeks)
  • The change of fasting glycemia(Change from Baseline fasting glycemia at 8 weeks)
  • The change of total cholesterol(Change from Baseline total cholesterol at 8 weeks)
  • The change of triglyceride(Change from Baseline triglyceride at 8 weeks)
  • The change of HDL-cholesterol(Change from Baseline HDL-cholesterol at 8 weeks)
  • The change of LDL-cholesterol(Change from Baseline LDL-cholesterol at 8 weeks)
  • The change of insulin(Change from Baseline insulin at 8 weeks)
  • The change of adiponectin(Change from Baseline adiponectin at 8 weeks)

研究者

发起方
TCI Co., Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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