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

Shenzhen Hospital of Southern Medical University

: 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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia
• Intervention / Treatment: Dietary supplement: Genistein

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 0086510282
      • Shenzhen Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genistein; Dietary Supplement: Genistein Hyperlipidemia patients take a 125mg Genistein capsule daily, once a day.	Dietary supplement: Genistein; Hyperlipidemia patients take a 125mg Genistein capsule daily, once a day.
No Intervention: Control; The control group does not take the Genistein medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum TMAO level	12 months
Fecal TMA level	12 months
Microbial flora structure	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum CHOL level	12 months
Serum TG level	12 months
Serum LDLC level	12 months

Collaborators and Investigators

• Sponsor: Shenzhen Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2024
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): February 20, 2025

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: gut microbiota; Genistein; hyperlipidemia; TMAO
• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Hyperlipidemias; Hyperlipoproteinemias; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Protein Kinase Inhibitors; Protective Agents; Estrogens; Phytoestrogens; Estrogens, Non-Steroidal; Anticarcinogenic Agents; Genistein
• Other Study ID Numbers: NYSZYYEC2024K072R001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No