Clinical trial NCT06890780: Observation on the Correlation Between Serum/Fecal Isoflavones, Abundance of TMA-producing Bacteria and Serum TMAO in Hyperlipidemia and Healthy Subjects
Official title: Zhujiang Hospital of Southern Medical University
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hyperlipidemia
Keywords: hyperlipidemia
TMAO
gut microbes
Isoflavone
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hyperlipidemia patients and healthy people

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.

Primary outcomes:
measure: Measurement of serum TMAO levels in two groups of hyperlipidemia and healthy subjects
timeFrame: 2023/01/01-2025/12/31
measure: Determination of fecal TMA production capacity in two groups of hyperlipidemic subjects and healthy subjects
timeFrame: 2023/01/01-2025/12/31
measure: The levels of fecal serum/fecal isoflavones in hyperlipidemic and healthy subjects were measured and their association with serum TMAO and TMA-producing strains was analyzed.
timeFrame: 2023/01/01-2025/12/31
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
References: