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临床试验/NCT07322575
NCT07322575尚未招募不适用

Evaluation of TMAO Production in Human Body From High-carnitine Diet by Fecal Gbu Gene Testing

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2026年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
65
试验地点
1
主要终点
Fecal gbu gene abundance measured by qPCR

研究概览

简要总结

The risk of cardiovascular diseases from red meat consumption varies among individuals due to variations in gut microbiota. L-carnitine in red meat can be converted to Trimethylamine n-oxide (TMAO) in the body by certain bacteria. Not everyone experiences a significant increase in TMAO levels after consuming carnitine. Gut microbiota differences are observed between high and low TMAO producers. The presence of the γ-butyrobetaine utilization (gbu) gene in gut microbiota is linked to TMAO production. This clinical research aims to determine if the gbu gene can predict TMAO levels after intaking a large amount of red meat.

详细描述

The risk of developing cardiovascular diseases due to the consumption of red meat varies among individuals, and this may be attributed to differences in the composition and function of gut microbiota. Studies have found that red meat, rich in L-carnitine, may be metabolized by certain anaerobic bacteria in the intestines to produce trimethylamine N-oxide (TMAO) in the human body. Previous research utilizing the oral carnitine challenge test (OCCT) revealed that not everyone experiences a significant increase in blood TMAO levels after consuming carnitine. Moreover, individuals with high TMAO production and low TMAO production showed distinct differences in their gut microbiota.

Furthermore, we have discovered a significant correlation between the abundance of the gbu gene in gut microbiota and the production of TMAO in response to dietary carnitine intake. Therefore, through the design of clinical research, we aim to investigate and assess whether the abundance of the gbu gene in gut microbiota can predict the levels of TMAO produced in the human body under a large amount of red meat consumption.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult with age between 18 to 70
  • Willing and capable of intaking a large amount of beef

排除标准

  • Antibiotics use within one month
  • L-carnitine supplement use within one month
  • Chronic diarrhea
  • Myasthenia gravis
  • Parathyroid disorders
  • Chronic kidney disease
  • Severe anemia
  • Severe cardiovascular diseases.

结局指标

主要结局

Fecal gbu gene abundance measured by qPCR

时间窗: up to 7-10 days

Blood TMAO level measured by LC-MS/MS

时间窗: before intervention, 24hr, 48hr after intervention

Platelet aggregation of blood by Light Transmission Aggregometry

时间窗: up to 7-10 days

Gut microbiome profiles measured by shotgun metagenome sequencing

时间窗: up to 7-10 days

次要结局

  • Carnitine intake measured by 24hr dietary record(up to 7-10 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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