Nutritional Effects in Cardiovascular Surgery

Fu Jen Catholic University

Status: Enrolling

Conditions: Cardiovascular Surgery; Cardiovascular Disease

Treatments: Other: probiotic supplementation intervention; Other: Placebo supplementation intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07497932

FJUH114505

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

Received standard postoperative care with probiotic supplementation

Treatment:

Other: probiotic supplementation intervention

Placebo group

Placebo Comparator group

Description:

Received standard postoperative care with placebo supplementation

Treatment:

Other: Placebo supplementation intervention