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

Launched by ZHUJIANG HOSPITAL · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how isoflavones, which are natural compounds found in certain foods, might help regulate gut bacteria and lower levels of a substance called TMAO in people with high cholesterol (hyperlipidemia) and healthy individuals. TMAO is linked to heart disease, and the study aims to understand if isoflavones can improve gut health and reduce TMAO levels, particularly in people who consume a high-fat diet. Researchers want to find out which isoflavones are effective, how they work with gut bacteria, and the overall impact on heart disease risk.

To participate in this trial, you need to be between 18 and 70 years old. If you have high cholesterol, you must have a medical diagnosis of hyperlipidemia. For healthy volunteers, there are specific weight and body mass index (BMI) requirements, and participants should be in good health without serious illnesses. You won’t be able to take any dietary supplements or certain medications before the study, and those with specific digestive conditions are excluded. If you join, you can expect to contribute to important research that could help in developing new strategies for heart disease prevention and treatment.

Gender

ALL

Eligibility criteria

• * Inclusion Criteria:
• * 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 Criteria:
• • 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.