The Clinical Study on Isoflavone Genistein in Restructuring the Gut Microbiota of Hyperlipidemia Patients

Launched by SHENZHEN HOSPITAL OF SOUTHERN MEDICAL UNIVERSITY · Mar 20, 2025

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)