Examining the link between gut bacteria, isoflavones, and cholesterol levels
Zhujiang Hospital of Southern Medical University
Zhujiang Hospital · NCT06890780
This study is testing how certain plant compounds in food might change gut bacteria and cholesterol levels in people with high cholesterol and healthy individuals to see if it can help improve heart health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06890780 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between serum and fecal isoflavones, the abundance of TMA-producing bacteria, and serum TMAO levels in individuals with hyperlipidemia and healthy subjects. It aims to explore how dietary isoflavones may influence gut microbiota and subsequently affect cardiovascular disease risk. By analyzing the gut microbiome's role in metabolizing isoflavones, the study seeks to provide insights into dietary interventions for managing cholesterol levels and cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 diagnosed with hyperlipidemia or healthy individuals meeting specific weight and BMI criteria.
Not a fit: Patients with chronic diseases or those taking certain medications that affect gut microbiota may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that help reduce cardiovascular disease risk in patients with hyperlipidemia.
How similar studies have performed: Previous studies have shown promising results regarding the impact of dietary isoflavones on cardiovascular health, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Waijiao Tang, PhD
- Email: tangwaijiao_2006@126.com
- Phone: +8615521281466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hyperlipidemia, hyperlipidemia, TMAO, gut microbes, Isoflavone