Nutritional Effects in Cardiovascular Surgery

March 23, 2026 updated by: Ke-Yun, Chao, Fu Jen Catholic University

Nutritional Intervention in the Modulation of Postoperative Metabolism in Cardiovascular Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 24352
        • Recruiting
        • Fu Jen Catholic University Hospital, Fu Jen Catholic University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic group
Received standard postoperative care with probiotic supplementation
Other: probiotic supplementation intervention
probiotic supplementation will be administered, while participants continue undergoing standard postoperative care
Placebo Comparator: Placebo group
Received standard postoperative care with placebo supplementation
Other: Placebo supplementation intervention
Undergo routine standard postoperative care with placebo intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trimethylamine-N-oxide
Time Frame: From enrollment to the end of intervention at 3 weeks
Gut microbiota-derived metabolites
From enrollment to the end of intervention at 3 weeks
Phenylacetylglutamine
Time Frame: From enrollment to the end of intervention at 3 weeks
Gut microbiota-derived metabolites
From enrollment to the end of intervention at 3 weeks
P-cresyl sulfate
Time Frame: From enrollment to the end of intervention at 3 weeks
Gut microbiota-derived metabolites
From enrollment to the end of intervention at 3 weeks
Indoxyl sulfate
Time Frame: From enrollment to the end of intervention at 3 weeks
Gut microbiota-derived metabolites
From enrollment to the end of intervention at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Jen Catholic University

Investigators

  • Principal Investigator: Ke-Yun Chao, PhD, Fu Jen Catholic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJUH114505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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