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临床试验 NCT07089732 针对肥胖症，糖尿病前期目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Effects of a GLP-1 Formula Drink on Gut Microbiota and Glycemic Control in Prediabetic Individuals 100 饮食
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临床试验NCT07089732是一项针对肥胖症，糖尿病前期的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2025年8月8日开始，预计招募100名患者。该研究由Chung Shan Medical University主导，计划于2026年6月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年7月28日。
简要概括
A clinical human dietary intervention trial was conducted to investigate the effects of GLP-1 FORMUL liquid supplementation in individuals with prediabetes or obesity, with a focus on improvements in glycemic and lipid parameters, body composition, and gut microbiota profiles.
详细描述
This 12-week randomized, placebo-controlled clinical trial aims to evaluate the nutritional and metabolic effects of GLP-1 FORMULA liquid supplementation. A total of 100 adult participants will be recruited and randomly assigned to one of two groups: (1) placebo group (n = 50), and (2) GLP-1 FORMULA group (n = 50). Participants will consume one bottle (50 g) of either GLP-1 FORMULA or placebo 30 minutes prior to thei...显示更多
官方标题
Evaluation of the Effects of GLP-1 Formula Liquid Drink on Gut Microbiota Modulation and Blood Glucose Regulation in Prediabetic Populations
疾病
肥胖症糖尿病前期其他研究标识符
- CS2-24199
NCT编号
实际开始日期
2025-08-08
最近更新发布
2025-07-28
预计完成日期
2026-06-30
计划入组人数
100
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
主要目的
预防
分配方式
随机
干预模型
平行
盲法
双盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性GLP-1 formula liquid drink GLP-1 formula liquid drink, 50 g/glass jar | GLP-1 formula liquid drink One glass jar (50 g) of the GLP-1 formula liquid drink was administered once daily, 30 minutes prior to the first meal of the day. |
安慰剂对照placebo The placebo contained the same base ingredients as the GLP-1 FORMULA but without the active GLP-1 FORMULA component. | 安慰剂 One glass jar (50 g) of the placebo liquid drink was administered once daily, 30 minutes prior to the first meal of the day. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change from baseline in BMI at weeks 8 and 12 | Assessment of changes in BMI at baseline, week 8, and week 12 | Week 0, 8 and 12 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change from baseline in blood glucose at weeks 8 and 12 | Assessment of blood glucose changes at weeks 0, 8, and 12 | Week 0, 8 and 12 |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
- Adults aged 18 to 70 years.
- Clinically diagnosed with prediabetes (fasting plasma glucose: 100-125 mg/dL or HbA1c: 5.7-6.4%) or with a body mass index (BMI) of 25-34.9 kg/m², male or female.
- Have not participated in similar clinical studies within the past three months.
- Able to comprehend the informed consent form, including the study procedures, potential risks, and benefits, and able to provide written informed consent.
- Diagnosed with autoimmune diseases or cancer.
- Diagnosed with gastrointestinal chronic diseases such as irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, celiac disease, bowel control disorders, fecal incontinence, pancreatitis, peptic ulcer disease, colorectal cancer, short bowel syndrome, ulcerative colitis, lactose intolerance, or chronic diarrhea.
- History of gastrointestinal surgery.
- Planning pregnancy in the near future (including male partners), currently pregnant, or breastfeeding women.
- Known allergy or hypersensitivity to probiotics or any of the study product ingredients.
- History of major psychiatric disorders.
- History of substance abuse or alcohol dependency.
Chung Shan Medical University研究中心联系人
联系人: Chin-Lin Hsu Professor, 04-24730022 Ext. 12222, [email protected]
1 位于 1 个国家/地区的研究中心
South
Chung Shan Medical University, Taichung, South, 402 Recruiting, Taiwan
Chin-Lin Hsu Professor, 联系人, 04-24730022 Ext. 12222, [email protected]