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Completed

NCT Number: NCT06895954

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

: 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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenzhen Hospital of Southern Medical University

Guangzhou, Guangdong, 0086510282, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Genistein

Dietary Supplement

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

Primary outcomes

  1. Serum TMAO level

    Time frame: 12 months

  2. Fecal TMA level

    Time frame: 12 months

  3. Microbial flora structure

    Time frame: 12 months

Secondary outcomes

  1. Serum CHOL level

    Time frame: 12 months

  2. Serum TG level

    Time frame: 12 months

  3. Serum LDLC level

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Shenzhen Hospital of Southern Medical University

Other

Registry information

Official study title

Shenzhen Hospital of Southern Medical University

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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