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

NCT06895954 | Completed DMC

• 1 other identifier: NYSZYYEC2024K072R001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hyperlipidemia

Keywords

Genistein; hyperlipidemia; gut microbiota; TMAO

Outcome Measures

Primary Outcomes (3)

• Serum TMAO level

  12 months

• Fecal TMA level

  12 months

• Microbial flora structure

  12 months

Secondary Outcomes (3)

• Serum CHOL level

  12 months

• Serum TG level

  12 months

• Serum LDLC level

  12 months

Study Arms (2)

Genistein

EXPERIMENTAL

Dietary Supplement: Genistein Hyperlipidemia patients take a 125mg Genistein capsule daily, once a day.

Dietary Supplement: Genistein

Control

NO INTERVENTION

The control group does not take the Genistein medication.

Interventions

Genistein DIETARY_SUPPLEMENT

Hyperlipidemia patients take a 125mg Genistein capsule daily, once a day.

Genistein

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shenzhen Hospital of Southern Medical University: lead

Study Sites (1)

Shenzhen Hospital of Southern Medical University

Guangzhou, Guangdong, 0086510282, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Genistein

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shenzhen Hospital of Southern Medical University

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: October 13, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: March 26, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)