NCT07618000招募中不适用
Evaluation of the Effects of the PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
研究概览
简要总结
The expected outcome of this study is that continuous 8-week supplementation with the PI-YSP-0111 prebiotic formulation will exert beneficial effects on gut microbiota modulation and liver health.
详细描述
All participants will undergo blood, urine, and fecal sample collection at baseline and after 8 weeks of supplementation. Body composition measurements and questionnaire assessments will be conducted at baseline, after 4 weeks, and after 8 weeks of supplementation. The collected data will be analyzed using a two-way mixed-design analysis of variance (ANOVA) to compare both between-group and within-group differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females aged 18 to 65 years.
- •BMI between 23.0 and 40.0 kg/m².
- •Waist circumference: ≥ 90 cm for males and ≥ 80 cm for females.
- •Participants are willing to maintain their usual dietary habits, daily routines, and physical activity levels during the study period, and have no plans to relocate.
- •Participants have fully understood the study procedures and have signed the informed consent form.
排除标准
- •Presence of gastrointestinal diseases, such as inflammatory bowel disease, irritable bowel syndrome, gastroesophageal reflux disease, Crohn's disease, or a history of bariatric surgery.
- •Recent history of acute gastroenteritis, constipation or diarrhea; psychiatric disorders (e.g., depression or schizophrenia); cardiovascular diseases (e.g., hypertension); known allergy or hypersensitivity to the investigational product; extreme dietary habits; significant body weight change (>4.5 kg) within the past three months; recent use of antibiotics or antifungal agents; or use of medications affecting gastrointestinal function (such as probiotics, laxatives, or nonsteroidal anti-inflammatory drugs [NSAIDs]).
- •Exposure to unapproved medications, alcohol abuse, or substance abuse.
- •Female-specific conditions, including significant gastrointestinal symptoms during menstruation, irregular menstrual cycles, pregnancy, planned pregnancy, or breastfeeding (participants who become pregnant during the study period will also be excluded).
- •Short-term use of corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressive agents, interferons, or immunomodulatory agents within the past one month.
- •Use of any weight-loss medications (including oral agents, injections, or traditional Chinese medicine) within the past three months.
- •Participation in any other interventional clinical study within the past one month.
- •History of cancer or current malignancy within the past two years, except for non-melanoma skin cancer.
- •Occurrence of major trauma or any surgical procedures within the past one month.
- •History of diabetic ketoacidosis.
研究者
研究点 (2)
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