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

NCT ID: NCT06890780

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-12-31

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?

Conditions

Hyperlipidemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hyperlipidemia population

Patients aged 18 to 70 years diagnosed with hyperlipidemia

No interventions assigned to this group

Healthy people

Between 18 and 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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 18-70 years old；
• patients diagnosed with hyperlipidemia；
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Waijiao Tang, PhD

Role: CONTACT

tangwaijiao_2006@126.com

+8615521281466

Facility Contacts

waijiao tang, PhD

Role: primary

tangwaijiao_2006@126.com

15521281466

Other Identifiers

2024-KY-099-01

Identifier Type: -

Identifier Source: org_study_id