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
Trial Information
Current as of April 23, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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)
About Shenzhen Hospital Of Southern Medical University
Shenzhen Hospital of Southern Medical University is a leading healthcare institution dedicated to advancing medical research and clinical excellence. As a prominent clinical trial sponsor, the hospital is committed to conducting rigorous and ethical research aimed at improving patient outcomes and enhancing therapeutic strategies. With a multidisciplinary team of experienced researchers and healthcare professionals, the hospital leverages its state-of-the-art facilities and innovative methodologies to facilitate groundbreaking studies across various medical fields. Its affiliation with Southern Medical University ensures a strong academic foundation, fostering collaboration and knowledge exchange in the pursuit of medical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Guangzhou, Guangdong, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported