Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
ID07497932

Nutritional Intervention in the Modulation of Postoperative Metabolism in Cardiovascular Surgery

Led by Fu Jen Catholic University · Updated on 2026-03-27

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study the distribution of gut microbiota-derived metabolites in patients undergoing cardiovascular surgery and to evaluate whether postoperative nutritional intervention with probiotics can influence the gut-heart metabolic axis. The goal is to see if this modulation can improve metabolic profiles and clinical outcomes related to cardiovascular disease, which remains a leading cause of death worldwide. The study also seeks to understand how these metabolites, linked to inflammation and vascular issues, are present in heart tissues and blood. Participants will have preoperative blood samples taken and cardiac tissue collected during surgery for detailed metabolite analysis using mass spectrometry. After surgery, some participants will receive probiotic supplements alongside standard postoperative care, while others will receive a placebo with standard care. Blood samples will be collected over time to monitor changes in metabolome and gut microbial composition during the 3-week intervention period. During the study, participants will provide blood and tissue samples and may receive probiotic or placebo supplements after surgery. Researchers will measure levels of specific gut microbiota-derived metabolites such as trimethylamine-N-oxide, phenylacetylglutamine, p-cresyl sulfate, and indoxyl sulfate from enrollment through the 3-week intervention. The trial includes randomization and double-blinding to ensure unbiased results, with continuous monitoring of metabolic changes and clinical outcomes through this period.

CONDITIONS

Brief Title

Nutritional Effects in Cardiovascular Surgery

Who Can Participate

Age: 50Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled to undergo cardiovascular surgery
  • Completed preoperative clinical and imaging evaluations
  • Willing to provide informed consent
  • Willing to receive potential probiotic supplementation
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for preoperative clinical and imaging evaluations

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo cardiovascular surgery with collection of blood and cardiac tissue samples during the procedure.

1 surgical visit (in-person)

Post-operative Treatment

Duration - 3 weeks

Participants receive standard postoperative care with either probiotic or placebo supplementation to modulate postoperative metabolism.

Weekly visits for postoperative monitoring and blood sample collection

Trial Site Locations

Total: 1 location

1

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, Taiwan, 24352

Actively Recruiting

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Research Team

K

Ke-Yun Chao, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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