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Nutritional Effects in Cardiovascular Surgery

Nutritional Intervention in the Modulation of Postoperative Metabolism in Cardiovascular Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07497932
Enrollment
30
Registered
2026-03-27
Start date
2026-03-19
Completion date
2026-12-31
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Cardiovascular Surgery

Keywords

Gut microbiota-derived metabolites, Metabolomics, Cardiovascular disease, Nutritional intervention, Mass spectrometry

Brief summary

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.

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.

Interventions

probiotic supplementation will be administered, while participants continue undergoing standard postoperative care

OTHERPlacebo supplementation intervention

Undergo routine standard postoperative care with placebo intervention

Sponsors

Fu Jen Catholic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Trimethylamine-N-oxideFrom enrollment to the end of intervention at 3 weeksGut microbiota-derived metabolites
PhenylacetylglutamineFrom enrollment to the end of intervention at 3 weeksGut microbiota-derived metabolites
P-cresyl sulfateFrom enrollment to the end of intervention at 3 weeksGut microbiota-derived metabolites
Indoxyl sulfateFrom enrollment to the end of intervention at 3 weeksGut microbiota-derived metabolites

Countries

Taiwan

Contacts

CONTACTKe-Yun Chao, PhD
C00152@mail.fjuh.fju.edu.tw+886-905-301-879
PRINCIPAL_INVESTIGATORKe-Yun Chao, PhD

Fu Jen Catholic University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026