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临床试验/NCT06175260
NCT06175260已完成不适用

Investigation on the Efficacy of Oral Carnitine Challenge Test Based on a Gut Microbiota Functional Test

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2019年6月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Trimethylamine N-oxide (TMAO) production capacity measured by oral carnitine challenge test (OCCT)

研究概览

简要总结

This study seeks to enlist healthy volunteers to form a validation cohort. The purpose is to confirm the observed correlations between the gut microbiome and the capacity to produce trimethylamine N-oxide (TMAO), which will be assessed using the oral carnitine challenge test (OCCT).

详细描述

Carnitine, a nutrient widely found in meat, can promote the use of fatty acids by mitochondria to produce energy in the human body. It was previously thought to be beneficial in helping the body consume fat for energy and might be helpful for muscle training or weight loss. However, some human populations have harmful bacteria in their intestines that compete with the body for the use of carnitine. These bacteria metabolize carnitine to produce potentially harmful Trimethylamine N-oxide (TMAO). This might be one of the reasons why long-term consumption of red meat, which is rich in carnitine, is associated with a higher risk of cardiovascular disease. Therefore, understanding the functional state of one's gut microbiota and whether it is suitable to consume foods rich in carnitine can greatly aid in long-term dietary and health planning. In recent years, we have established an oral carnitine challenge test that (OCCT) can distinguish whether the intestinal bacteria in a subject produce a large amount of TMAO in the body. This was published in the Gut journal in 2019 and is expected to provide dietary or nutritional supplement recommendations for personalized nutrition for the test subjects. However, the value of the carnitine challenge test in distinguishing between high TMAO producers and low TMAO producers, and whether it can serve as an effective reference for whether a subject is suitable to consume large amounts of meat or take carnitine supplements, still needs further experimental verification. This study seeks to enlist healthy volunteers to form a validation cohort. The purpose is to confirm the observed correlations between the gut microbiome and the capacity to produce TMAO, which will be assessed using the OCCT.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • adults aged 20 and above who are willing to participate in the trial.

排除标准

  • Under the age of 20
  • History of gastrointestinal surgery
  • History of malignant tumors
  • Those who have used antibiotics, probiotics, or carnitine supplements within the past month will be excluded
  • Liver cirrhosis
  • End-stage kidney disease

结局指标

主要结局

Trimethylamine N-oxide (TMAO) production capacity measured by oral carnitine challenge test (OCCT)

时间窗: at enrollment

The area under the curve of TMAO levels under OCCT

次要结局

  • Correlations between the gut microbiome and the capacity to produce TMAO(at enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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