NCT06890780 Observation on the Correlation Between Serum/Fecal Isoflavones, Abundance of TMA-producing Bacteria and Serum TMAO in Hyperlipidemia and Healthy Subjects
| NCT ID | NCT06890780 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhujiang Hospital |
| Condition | Hyperlipidemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2024-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-01-01 with a primary completion date of 2024-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 regulate the structure of gut microbiota to reduce circulating TMAO levels in the host is currently one of the hot topics in research. Diet is a major factor shaping the structure of gut microbiota. Through the exploration of dietary elements, we have found that multiple epidemiological studies suggest an inverse correlation between the intake of isoflavones and CVD, indicating that isoflavones are potential agents for the prevention and treatment of CVD. Interestingly, isoflavones have poor water solubility and low bioavailability. Several studies have confirmed interactions between isoflavones and gut microbiota, suggesting that the gut and gut microbiota are likely important therapeutic targets for isoflavones in preventing and treating CVD. Furthermore, a high-fat diet (HFD) is also an independent risk factor for CVD. Research literature indicates that HFD can disrupt both the gut and gut microbiota. As a biomarker for CVD risk, TMAO has been reported in some studies to increase in circulation following HFD intake, but the mechanisms behind this phenomenon require further exploration. Based on the above literature, we propose a scientific hypothesis: Can isoflavones regulate gut microbiota and subsequently reduce serum TMAO levels in HFD-fed mice? This hypothesis can be further divided into three specific scientific questions: Which isoflavones can reduce serum TMAO levels in HFD-fed mice? Is gut microbiota the key factor through which isoflavones reduce serum TMAO levels in HFD-fed mice? What mechanisms do these substances use to modulate gut microbiota?
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06890780 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Hyperlipidemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06890780 currently recruiting?
Yes, NCT06890780 is actively recruiting participants. Contact the research team at tangwaijiao_2006@126.com for enrollment information.
Where is the NCT06890780 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06890780 clinical trial?
NCT06890780 is sponsored by Zhujiang Hospital. The trial plans to enroll 200 participants.