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

Shenzhen Hospital of Southern Medical University

Status

Completed

Conditions

Hyperlipidemia

Treatments

Dietary Supplement: Genistein

Study type

Interventional

Funder types

Other

Identifiers

NCT06895954

NYSZYYEC2024K072R001

Details and patient eligibility

About

: 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 microbiota. Furthermore, we discovered that Genistein's regulatory effect on the gut microbiota in high-fat diet mice relies on the host colonic PKI-Nos2 pathway. Genistein is an isoflavone compound extracted from soybeans and is the most effective functional ingredient in soybean isoflavone products. It has multiple physiological functions, and several randomized controlled trials (RCTs) have shown that the intake of Genistein can effectively alleviate hyperlipidemia, obesity, metabolic syndrome, and cardiovascular diseases, suggesting its safety and efficacy as a clinical health supplement. Therefore, we aim to conduct clinical trials to further demonstrate that Genistein also influences the gut microbiota in hyperlipidemia patients, thereby reducing serum TMAO levels.

Enrollment

36 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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)