跳至主要内容
临床试验/NCT07497932
NCT07497932招募中不适用

Nutritional Intervention in the Modulation of Postoperative Metabolism in Cardiovascular Surgery

Fu Jen Catholic University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Trimethylamine-N-oxide

研究概览

简要总结

This study aims to investigate the distribution of gut microbiota-derived metabolites, and to evaluate whether postoperative nutritional intervention can modulate the gut-heart metabolic axis, thereby improving metabolic profiles and clinical outcomes.

详细描述

Background: Cardiovascular diseases remain the leading cause of mortality worldwide. Recent research has highlighted the role of gut microbiota and its metabolites-such as trimethylamine-N-oxide, phenylacetylglutamine, and p-cresyl sulfate-in the pathogenesis of cardiovascular disease through mechanisms involving inflammation, oxidative stress, and vascular dysfunction. However, little is known about the actual distribution of these metabolites in human cardiac tissues or their correlation with circulating levels. No clinical studies to date have systematically examined both tissue and blood samples in this context.

Methods: Preoperative blood samples and intraoperative cardiac tissue specimens will be collected. Both targeted and untargeted metabolomics analyses will be performed using mass spectrometry to detect key gut microbiota-derived metabolites. A subset of patients will receive postoperative probiotic supplementation. Serial blood will be collected to monitor changes in the metabolome and gut microbial composition.

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, Care Provider)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled to undergo cardiovascular surgery
  • Completed preoperative clinical and imaging evaluations
  • Willing to provide informed consent
  • Willing to receive potential probiotic supplementation

排除标准

  • Use of antibiotics, probiotics, or other treatments affecting gut microbiota within 4 weeks
  • History of major gastrointestinal disease

结局指标

主要结局

Trimethylamine-N-oxide

时间窗: From enrollment to the end of intervention at 3 weeks

Gut microbiota-derived metabolites

Phenylacetylglutamine

时间窗: From enrollment to the end of intervention at 3 weeks

Gut microbiota-derived metabolites

P-cresyl sulfate

时间窗: From enrollment to the end of intervention at 3 weeks

Gut microbiota-derived metabolites

Indoxyl sulfate

时间窗: From enrollment to the end of intervention at 3 weeks

Gut microbiota-derived metabolites

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ke-Yun, Chao

Assistant Professor

Fu Jen Catholic University

研究点 (1)

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