HyperlipidemiaNCT06890780
Observation on the Correlation Between Serum/Fecal Isoflavones, Abundance of TMA-producing Bacteria and Serum TMAO in Hyperlipidemia and Healthy Subjects
An observational study of Hyperlipidemia, run by Zhujiang Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hyperlipidemia patients and healthy people
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 0086510282
waijiao tang, PhD, 15521281466, tangwaijiao_2006@126.com
About this study
Official title: Zhujiang Hospital of Southern Medical University
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:
Read more
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
- Keywords
- hyperlipidemia, TMAO, gut microbes, Isoflavone
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hyperlipidemia population | Patients aged 18 to 70 years diagnosed with hyperlipidemia | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of serum TMAO levels in two groups of hyperlipidemia and healthy subjects
Serum was collected from two groups of people, hyperlipidemia patients and healthy subjects, and serum TMAO levels were measured by LC-MS.
Measured: 2023/01/01-2025/12/31
Determination of fecal TMA production capacity in two groups of hyperlipidemic subjects and healthy subjects
Serum was collected from two groups of people with hyperlipidemia and healthy subjects, and the fecal TMA production capacity of the two groups was determined by LC-MS. 16SrRNA sequencing was performed to identify strains with TMA production capacity.
Measured: 2023/01/01-2025/12/31
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.
Simultaneously, we screened nutrients related to TMA-producing metabolic pathways in non-targeted metabolomics, such as isoflavones. Are they negatively correlated with these TMA-producing metabolic pathways? At the same time, targeted determinations were used to further screen isoflavones that have the potential to regulate TMA-producing bacterial communities. Through subsequent sample collection and metabolite analysis, we verified the regulatory ability of isoflavones on TMA-producing bacteria and clarified the biological mechanism behind them.
Measured: 2023/01/01-2025/12/31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890780
- Sponsor's protocol ID
- 2024-KY-099-01
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zhujiang Hospital of Southern Medical University
- ClinicalTrials.gov ID
- NCT06890780
- Acronym / sponsor ID
- 2024-KY-099-01
- Conditions
- Hyperlipidemia
- Keywords
- hyperlipidemia, TMAO, gut microbes, Isoflavone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperlipidemia population | – | –Patients aged 18 to 70 years diagnosed with hyperlipidemia |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hyperlipidemia patients and healthy people
Key inclusion criteria (7 listed)
- Hyperlipidemia inclusion criteria:
- 18-70 years old；
- patients diagnosed with hyperlipidemia；
- Healthy people inclusion criteria:
- 18-70 years old；
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of serum TMAO levels in two groups of hyperlipidemia and healthy subjects
Time frame: 2023/01/01-2025/12/31
Serum was collected from two groups of people, hyperlipidemia patients and healthy subjects, and serum TMAO levels were measured by LC-MS.
Determination of fecal TMA production capacity in two groups of hyperlipidemic subjects and healthy subjects
Time frame: 2023/01/01-2025/12/31
Serum was collected from two groups of people with hyperlipidemia and healthy subjects, and the fecal TMA production capacity of the two groups was determined by LC-MS. 16SrRNA sequencing was performed to identify strains with TMA production capacity.
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.
Time frame: 2023/01/01-2025/12/31
Simultaneously, we screened nutrients related to TMA-producing metabolic pathways in non-targeted metabolomics, such as isoflavones. Are they negatively correlated with these TMA-producing metabolic pathways? At the same time, targeted determinations were used to further screen isoflavones that have the potential to regulate TMA-producing bacterial communities. Through subsequent sample collection and metabolite analysis, we verified the regulatory ability of isoflavones on TMA-producing bacteria and clarified the biological mechanism behind them.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemia, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Waijiao Tang, PhD (+8615521281466, tangwaijiao_2006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of serum TMAO levels in two groups of hyperlipidemia and healthy subjects (time frame: 2023/01/01-2025/12/31). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.