Shenzhen Hospital of Southern Medical University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Serum TMAO level
研究概览
简要总结
: 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Serum TMAO level
时间窗: 12 months
Fecal TMA level
时间窗: 12 months
Microbial flora structure
时间窗: 12 months
次要结局
- Serum CHOL level(12 months)
- Serum TG level(12 months)
- Serum LDLC level(12 months)
研究者
Hongwei Zhou
Shenzhen Hospital of Southern Medical University
Shenzhen Hospital of Southern Medical University