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临床试验/NCT04457661
NCT04457661已完成不适用

Evaluation of the Alcohol Elimination Effect of TCI711 Probiotic (Bacillus Coagulans) on Adult Individuals

TCI Co., Ltd.1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2020年7月13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
TCI Co., Ltd.
入组人数
19
试验地点
1
主要终点
Breath Alcohol Level

研究概览

简要总结

Investigating the possibility of using Bacillus coagulans TCI711 to improve the efficiency of alcohol removal in adult individuals.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy volunteers aged between 20 to
  • •Systolic pressure below 140
  • •Score of C-CAGE Questionnaire below 8 (male)/6 (female)
  • •Prohibiting other supplements before 2 weeks of the study and during the study
  • •Prohibiting alcohol drinks before 24 hours of the study
  • •Prohibiting caffeine drinks before 12 hours of the study

排除标准

  • •Alcohol or drug allergy
  • •Liver, kidney, cardiovascular, or chronic diseases
  • •Other severe disorders
  • •Hypertension
  • •Pregnancy or lactation
  • •Already involved in clinical testing
  • •Other supplements

研究组 & 干预措施

TCI711 probiotic

Experimental

Taking one capsule (containing 10^10 of Bacillus coagulans TCI711) daily for one month

干预措施: Bacillus coagulans TCI711 (Dietary Supplement)

结局指标

主要结局

Breath Alcohol Level

时间窗: 180 minutes after drinking a certain volume of whisky

A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

Breath Alcohol Level

时间窗: 5 minutes after drinking a certain volume of whisky

A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

Breath Alcohol Level

时间窗: 15 minutes after drinking a certain volume of whisky

A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

Breath Alcohol Level

时间窗: 30 minutes after drinking a certain volume of whisky

A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

Breath Alcohol Level

时间窗: 60 minutes after drinking a certain volume of whisky

A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

Breath Alcohol Level

时间窗: 90 minutes after drinking a certain volume of whisky

A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

Breath Alcohol Level

时间窗: 120 minutes after drinking a certain volume of whisky

A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

Breath Alcohol Level

时间窗: 150 minutes after drinking a certain volume of whisky

A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

次要结局

未报告次要终点

研究者

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

研究点 (1)

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