Status:

RECRUITING

Observation on the Correlation Between Serum/Fecal Isoflavones, Abundance of TMA-producing Bacteria and Serum TMAO in Hyperlipidemia and Healthy Subjects

Lead Sponsor:

Zhujiang Hospital

Conditions:

Hyperlipidemia

Eligibility:

All Genders

18-70 years

Brief Summary

Previous studies have shown that trimethylamine N-oxide (TMAO), a gut microbiota-related metabolite, plays a significant role in the development and progression of cardiovascular disease (CVD). How to...

Eligibility Criteria

Inclusion

  • Hyperlipidemia inclusion criteria:
  • 18-70 years old;
  • patients diagnosed with hyperlipidemia;
  • Healthy people inclusion criteria:
  • 18-70 years old;
  • male weight ≥50.0kg, female weight ≥45.0kg; body mass index (BMI) within the range of 19.0-26.0 kg/m2 (including critical values);
  • volunteers have no history of chronic diseases or serious diseases such as cardiovascular, liver, kidney, respiratory, blood and lymphatic, endocrine, immune, mental, neuromuscular, gastrointestinal system within three years, and are in good overall health.

Exclusion

  • Consuming dietary supplements (ω-3 fatty acids, probiotics, prebiotics, plant stanols/sterols) 1 month before the study;
  • Using antibiotics, antidiarrheal drugs, statins, fibrates and other drugs within 2 months before the study;
  • Drinking alcohol (\> 2 cups per day);
  • Hyperlipidemia patients with inflammatory bowel disease or irritable bowel syndrome and healthy people.

Key Trial Info

Start Date :

January 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06890780

Start Date

January 1 2023

End Date

December 31 2025

Last Update

March 24 2025

Active Locations (1)

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Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 0086510282