Zein Nanoparticles for Glycemic Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Change in Fructosamine
研究概览
简要总结
The use of zein nanoparticles as vehicles for drug delivery is under study, but of the effects observed in empty nanoparticles, in laboratory animals, the reduction of glucose levels was something worth studying. Thus, the present research on patients with prediabetes has been proposed. The objective is to assess the efficacy of zein nanoparticles on the glycemic control. For this purpose, a randomized, double blind crossover study has been designed.
Target sample size is 60.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The products (experimental and Placebo), will be produced by an external producer, who will retain the codes. None of the researchers involved in the study development or analyses will know the association until the end of the study.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight or obesity (BMI between 25 and 40 kg/m2
- •Presence of prediabetes (fasting glycemia in blood between 100 and 126 mg/dL)
- •No weight variations considered relevant (+/- 5%) in the last 3 months
- •Metformin treatment is allowed, as far as dose is stable (at least 2 months with unvaried dose).
- •Good physical and psychological state.
排除标准
- 未提供
研究组 & 干预措施
control
Subjects will consume daily a powder dissolved in water with zein
干预措施: control (Dietary Supplement)
Zein nanocapsules
Subjects will consume daily a powder dissolved in water with nanoencapsulated zein
干预措施: Zein nanocapsules (Dietary Supplement)
结局指标
主要结局
Change in Fructosamine
时间窗: 28 days
Change in the levels of Fructosamine From day 0 to day 28
Change in GLP-1 AUC
时间窗: Baseline, 15, 30, 45 and 60 minutes
Change in AUC of postprandial GLP-1 levels after OGTT
次要结局
- Continuous glucose levels(28 days)
- Fasting Plasma glucose(28 days)
- Insulin Levels(28 days)