Effects of Sucralose on Insulin Sensitivity, Pancreatic Response and Appetite Regulating Hormones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Insulin sensitivity
研究概览
简要总结
In this study the effects of sucralose on insulin sensitivity, beta-cell response and appetite regulating hormones will be evaluated.
详细描述
The consumption of non-nutritive sweeteners has a high prevalence. The effect of non-nutritive sweeteners in both beta-cell function and insulin resistance it is unknown.
Previous studies performed in animal models and humans with diverse characteristics have shown variable effects of different non-nutritive sweeteners in variables related to glucose metabolism.
Due to the high consumption of non-nutritive sweeteners it is relevant to know its effect in beta cell-function and insulin sensitivity.
In this study the effects of sucralose, a non-nutritive sweetener that is highly consumed in the population, on insulin sensitivity and beta-cell function will be evaluated.
54 participants with normal glucose tolerance, normal weight, and without chronic diseases with a low consumption of non-nutritive sweeteners will be included. The participants will be randomly assigned to consume sucralose or to a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •both genders
- •age between 18 and 55 years
- •body mass index ≥18.5 and <25 kg/m2
- •low consumption of non-nutritive sweeteners
排除标准
- •diabetes or glucose intolerance
- •consumption of medications affecting insulin sensitivity (metformin, steroids, hormone replacement therapy, contraceptives)
- •intestinal disease such as malabsorption or previous intestinal resection
- •history of bariatric surgery
- •pregnancy or lactation
- •weight loss greater than 5% in the previous month
研究组 & 干预措施
Control
Absence of sucralose ingestion
Sucralose
Ingestion of 15% of the ADI of sucralose daily during two weeks
干预措施: Sucralose (Other)
结局指标
主要结局
Insulin sensitivity
时间窗: Two weeks
Insulin sensitivity and pancreatic response estimated with the minimal model using a frequently sampled IV glucose tolerance test
次要结局
- Leptin change(Two weeks)
- Glucagon like peptide (GLP-1) change(Two weeks)
- Ghrelin change(Two weeks)
- Tyrosine-tyrosine peptide (PYY) change(Two weeks)