NCT07013409已完成不适用
Safety and Efficacy of Lacticaseibacillus Rhamnosus LRa05, Lactobacillus Crispatus LCr86 and Limosilactobacillus Reuteri LR08 on Hormone Metabolism, Body Composition, and Emotional Regulation in Overweight Women
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- The changes of estradiol before and after the intervention
研究概览
简要总结
To evaluate the regulatory effect of probiotics formula on visceral fat metabolism and sex hormone balance in obese women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18 to 40 years old, female, BMI ≥ 25 kg/m
- •Be willing to receive follow-up during the intervention period.
- •Be willing to provide two blood, urine and fecal samples during the intervention period.
- •Be willing to take the compound probiotics by oneself every day during the intervention period.
- •Have good hearing and be able to hear and understand all instructions during the intervention period.
排除标准
- •Suffering from digestive system diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease).
- •Suffering from severe neurological disorders (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, long-term coma - excluding general anesthesia).
- •Have received/are currently receiving treatment for the following mental illnesses: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder.
- •Take medication for depression or low mood.
- •Suffering from internal organ failure (such as heart, liver or kidney failure, etc.).
- •Have received radiotherapy or chemotherapy in the past.
- •Have received general anesthesia surgery/procedures within the past three years, or plan to receive general anesthesia procedures/surgeries within the next three months during this trial.
- •Have suffered from hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past.
研究组 & 干预措施
Probiotic Group
Experimental
Take 30 billion CFU of complex probiotics every day
干预措施: Probiotic (Dietary Supplement)
Placebo Group
Placebo Comparator
Taking maltodextrin 3 g/day.
干预措施: Maltodextrin (Dietary Supplement)
结局指标
主要结局
The changes of estradiol before and after the intervention
时间窗: 0, 1, 2, 3 months
The serum estrogen content of the subjects before and after the intervention was detected by enzyme-linked immunosorbent assay.
次要结局
未报告次要终点
研究者
研究点 (2)
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