Nutritional Effects in Cardiovascular Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: probiotic supplementation intervention, Placebo supplementation intervention.
- Who it may be relevant to
- Registry conditions: Cardiovascular Surgery, Cardiovascular Disease. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Nutritional Intervention in the Modulation of Postoperative Metabolism in Cardiovascular Surgery
Overview
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
- Other probiotic supplementation intervention
probiotic supplementation will be administered, while participants continue undergoing standard postoperative care - Other Placebo supplementation intervention
Undergo routine standard postoperative care with placebo intervention
Primary outcome measures
- Trimethylamine-N-oxide [Time frame: From enrollment to the end of intervention at 3 weeks]
- Phenylacetylglutamine [Time frame: 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]
- Indoxyl sulfate [Time frame: From enrollment to the end of intervention at 3 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Taiwan · 1 center
- Fu Jen Catholic University Hospital, Fu Jen Catholic University — New Taipei City
Identifiers
NCT: NCT07497932 · FJUH114505