Status:
COMPLETED
The Clinical Study on Isoflavone Genistein in Restructuring the Gut Microbiota of Hyperlipidemia Patients
Lead Sponsor:
Shenzhen Hospital of Southern Medical University
Conditions:
Hyperlipidemia
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief Summary
: In preliminary animal experiments, we found that the soybean isoflavone compound Genistein could reduce serum TMAO levels in high-fat diet (HFD) mice, and this effect was dependent on the gut microb...
Eligibility Criteria
Inclusion
- Aged between 30-65 years old, regardless of gender
- Abnormal donation and loan: including elevated total cholesterol and triglycerides, high triglycerides, and high triglycerides
- Volunteer to participate in clinical trials, understand and sign the informed consent form
Exclusion
- Patients who do not meet the inclusion criteria
- Patients with gastrointestinal or chronic infectious diseases (i.e., diarrhea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticular disease, gastric or duodenal ulcer, hepatitis, HIV, cancer, etc.), or with a history of such diseases
- Chronic or acute kidney disease, eGFR \< 50 in two or more laboratory tests in the past 6 months; diagnosis of cirrhosis or liver failure; hyperkalemia (defined as potassium \> 5.4 in two or more laboratory tests in the past 6 months)
- Severe immunodeficiency (HIV positive, transplant patients, taking anti-rejection drugs, taking steroids for \> 30 days, or receiving chemotherapy or radiotherapy in the past year)
- Alarm features such as weight loss, rectal bleeding, recent changes in bowel habits (\< 3 months), or abdominal pain
- Patients with malignant diseases or any concomitant end-stage organ diseases
- Patients who have taken any antibiotics or dietary supplements (prebiotics, probiotics, fiber, resveratrol, fish oil, seed oil, ginkgo leaf, ginseng, fruit powder extract and DHA) within one month
- Patients who have taken any Chinese patent medicine or Chinese herbal decoction within one month
- Avoid eating seafood or fish 24 hours before each visit
- Vegetarian/vegan diet or food allergies or other food problems that will prevent the intake of research products
- Pregnant or preparing for pregnancy and breastfeeding women
- Allergic constitution, or known allergy to isoflavone genistein
- Participating in other drug clinical studies within 1 month
- According to the investigator's judgment, the patient cannot complete this study or cannot comply with the requirements of this study (due to management reasons or other reasons)
Key Trial Info
Start Date :
October 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06895954
Start Date
October 13 2024
End Date
February 20 2025
Last Update
March 26 2025
Active Locations (1)
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1
Shenzhen Hospital of Southern Medical University
Guangzhou, Guangdong, China, 0086510282