Last reviewed · How we verify
NCT06890780
Observation on the Correlation Between Serum/Fecal Isoflavones, Abundance of TMA-producing Bacteria and Serum TMAO in Hyperlipidemia and Healthy Subjects
trial in Hyperlipidemia in 200 participants. Currently enrolling.
1 January 2024
Quick facts
| Lead sponsor | Zhujiang Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 1 January 2023 |
| Primary completion | 1 January 2024 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across China |
Conditions studied
- Hyperlipidemia — all drugs for Hyperlipidemia →
Sponsor
Zhujiang Hospital
Who can join
Adults 18 to 70, any sex, with Hyperlipidemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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?
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06890780
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hyperlipidemia
Currently open trials in the same condition.
- NCT06966258 — Inspire HER: Inspiring the Heart and Emotions for Radical Health · NA · recruiting
- NCT07216482 — A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037) · Phase 3 · recruiting
- NCT06615609 — "Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Coronary Artery Bypass Graft · NA · recruiting
- NCT07400549 — Prospective Exploratory Study on the Comprehensive Application Effectiveness of Exercise Prescription Decision Support T · NA · recruiting
- NCT06603363 — Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT · NA · recruiting
Other Zhujiang Hospital trials
Trials by the same sponsor.
- NCT07335094 — A Clinical Study of Humanized CD19 CAR-T Cells With TLR2 for the Treatment of Adult Patients With Naive B-Cell Acute Lym · EARLY_PHASE1 · not yet recruiting
- NCT07469072 — Comparison of Anticoagulant Effects of Different Doses of Nafamostat in Continuous Renal Replacement Therapy (CRRT) in t · Phase 2 · recruiting
- NCT07455149 — An Observational Clinical Study on the Association of Intestinal Ruminococcus Gnavus and Its Derived Biogenic Amines Wit · not yet recruiting
- NCT07457099 — Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Resectable Locally Advanced Oral a · not yet recruiting
- NCT07454421 — Racecadotril for Organ Injury in Sepsis Patients · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06890780 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zhujiang Hospital
- Last refreshed: 24 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06890780.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing