跳至主要内容
临床试验/NCT04303481
NCT04303481已完成不适用

The Effect of Consuming Enzymes and Prebiotics on Body Composition and Blood Biochemical Index

TCI Co., Ltd.2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2019年8月10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
88
试验地点
2
主要终点
The change of HDL-cholestrol

研究概览

简要总结

To assess the effects of consuming enzymes and prebiotics on improvement of weight loss and biochemical parameters

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female aged between 20 and 50 years old
  • Body mass index (BMI) ≥ 22 (kg/m^2) or body fat mass: male > 25%, female > 30%
  • Prohibitions on other nutritional supplements (probiotics and prebiotics) before two weeks of the study
  • Abidance by the similar diet and exercise habits over the study.

排除标准

  • Pregnant or breastfeeding woman
  • Menopausal woman
  • Diabetes mellitus
  • Implementation in weight loss programs before a half year of this study
  • Metabolic disorders
  • Kidney diseases
  • Liver diseases
  • Cardiovascular diseases
  • Nervous system diseases
  • Gastrointestinal diseases
  • Heavy drinking or constant drug use.

结局指标

主要结局

The change of HDL-cholestrol

时间窗: Months 0, 1 and 2

Venous blood was sampled to measure concentrations of HDL-cholestrol

The change of LDL-cholestrol

时间窗: Months 0, 1 and 2

Venous blood was sampled to measure concentrations of LDL-cholestrol

The change of visceral fat

时间窗: Months 0, 1 and 2

The visceral fat (10 cm\^2) was assessed by InBody770.

The change of body fat mass

时间窗: Months 0, 1 and 2

The body fat mass (kg) was assessed by InBody770.

The change of Triglyceride

时间窗: Months 0, 1 and 2

Venous blood was sampled to measure concentrations of Triglyceride

Fecal microbiome analysis

时间窗: Months 0, 1 and 2

Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR.

The change of body fat percentage

时间窗: Months 0, 1 and 2

The body fat percentage (%) was assessed by InBody770.

The change of Total cholestrol

时间窗: Months 0, 1 and 2

Venous blood was sampled to measure concentrations of Total cholestrol

The change of body mass index (BMI)

时间窗: Months 0, 1 and 2

BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m\^2) and body mass (kg) were assessed by InBody770.

次要结局

  • The change of white blood cell(Months 0, 1 and 2)
  • The change of uric acid(Months 0, 1 and 2)
  • The change of alanine aminotransferase(Months 0, 1 and 2)
  • The change of creatine(Months 0, 1 and 2)
  • The change of fasting glycemia(Months 0, 1 and 2)
  • The change of aspartate aminotransferase(Months 0, 1 and 2)
  • The change of albumin(Months 0, 1 and 2)

研究者

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

研究点 (2)

Loading locations...

相似试验