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临床试验/NCT02650947
NCT02650947已完成不适用

Effects of Sucralose Consumption on Glucose Metabolism, Incretin and Gut Microbiota in Healthy Adult

Ramathibodi Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
The effect of sucralose on insulin secretion

研究概览

简要总结

Hypothesis:

  1. Long-term consumption of sucralose may effect glucose metabolism, incretin hormone secretion and gut microbiota in healthy adults.
  2. Long-term consumption of sucralose may alter food behaviour in healthy adults.

详细描述

Artificial sweeteners such as sucralose, are among the most widely used food additives worldwide. Artificial sweetener consumption is considered safe and beneficial owing to their low caloric content. However, many emerging evidences showed artificial sweeteners may induce glucose intolerance. The objectives of this study were to determine the effect of sucralose on glycemic response, insulin secretion, insulin sensitivity, incretin response, gut microbiota and food behavior in healthy subjects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers without underlying disease
  • Normal oral glucose tolerance test
  • Agree to participate by written informed consent

排除标准

  • Shift workers
  • History of diabetes mellitus or prediabetes (impaired fasting glucose and/or glucose tolerance test)
  • Malabsorption problem
  • Regular consumption of nonnutritive sweeteners
  • Liver impairment (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3-folds upper normal limit)
  • Renal impairment (serum creatinine >1.5 mg/dL)
  • Use of medications affecting glucose level such as glucocorticoid, estrogen, androgen
  • Pregnant and lactating woman
  • Smoking within 6 months

结局指标

主要结局

The effect of sucralose on insulin secretion

时间窗: 2 hours

We will measure plasma insulin concentrations before and at 0, 2, 3, 4, 5, 6, 8, 10 minutes after administered intravenously 50%glucose 0.3 g/kg within 1 minute. All these data collected were used to calculate acute insulin response to glucose.

次要结局

  • Gut microbiota(4 weeks)
  • Glucagon-like peptide-1 secretion(2 hours)
  • Food record(4 weeks)
  • The effect of sucralose on insulin sensitivity(2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chutintorn Sriphrapradang

Assistant Professor

Ramathibodi Hospital

研究点 (2)

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