Nutritional Intervention in the Modulation of Postoperative Metabolism in Cardiovascular Surgery
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
- 否
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
Ke-Yun, Chao
Assistant Professor
Fu Jen Catholic University
