跳至主要内容
临床试验/NCT02413424
NCT02413424已完成不适用

Metabolic Effects of Non-nutritive Sweeteners

University of Illinois at Urbana-Champaign2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2015年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Glucose rate of appearance

研究概览

简要总结

The purpose of this research study is to examine whether sugar-replacement sweeteners that are currently on the market (ex. Sucralose, which is in Splenda) change how well the body works to control blood sugar.

详细描述

The investigators of this study have recently found that sucralose, the most commonly used non-nutritive sweetener (NNS), affects the glycemic response to an oral glucose tolerance test (OGTT) and potentiates glucose-stimulated insulin secretion in obese people who are not regular consumers of NNS. However, studies conducted in healthy lean adults, none of which control for previous use of NNS, show that sucralose does not affect glycemic or hormonal responses to the ingestion of glucose or other carbohydrates. Therefore, we do not know a) whether sucralose effects are limited to obese subjects, or are generalizable to lean people when controlling for prior history of NNS consumption, and b) mechanism(s) responsible for the acute effect of sucralose on glucose metabolism as we measured in obese subjects. The aim of this study is to determine the effects of an acute intake of sucralose on the metabolic response to an oral glucose tolerance test in lean and obese people.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI ≥ 30 kg/m2 or BMI ≥ 18 kg/m2 and BMI<25 kg/m2
  • "insulin sensitive": based on the homeostasis model assessment of insulin resistance (HOMA-IR) <3

排除标准

  • BMI ≥ 25 kg/m2 and BMI<30 kg/m2
  • HOMA-IR>3
  • Current smoker or quit smoking less than 6 months ago
  • pregnancy or breastfeeding
  • subjects who have malabsorptive syndromes, phenylketonuria, inflammatory intestinal disease, liver or kidney diseases, diabetes
  • subjects who are taking any medication that might affect metabolism
  • regular use of non-nutritive sweeteners

研究组 & 干预措施

Drink Sucralose

Experimental

Subjects will drink sucralose 10 min before drinking a glucose load

干预措施: Sucralose (Dietary Supplement)

Drink Sucralose

Experimental

Subjects will drink sucralose 10 min before drinking a glucose load

干预措施: glucose load (Dietary Supplement)

Drink Water

Placebo Comparator

Subjects will drink water 10 min before drinking a glucose load

干预措施: glucose load (Dietary Supplement)

Taste and spit Sucralose

Experimental

Subjects will taste and spit up sucralose 10 min before drinking a glucose load

干预措施: glucose load (Dietary Supplement)

Taste and spit Sucralose

Experimental

Subjects will taste and spit up sucralose 10 min before drinking a glucose load

干预措施: Sucralose (Dietary Supplement)

Drink Water

Placebo Comparator

Subjects will drink water 10 min before drinking a glucose load

干预措施: Water (Other)

结局指标

主要结局

Glucose rate of appearance

时间窗: up to 5 hours after drinking a glucose load

Blood samples will be collected before and for 5 hours after drinking a glucose load to determine glucose and glucose tracer:tracee ratios.

Peak insulin secretion rate

时间窗: up to 5 hours after drinking a glucose load

Blood samples will be collected before and for 5 hours after drinking a glucose load to determine plasma insulin and C-peptide. Insulin secretion rate will be assessed using the minimal model of Breda and collaborators.

次要结局

  • Glucose-dependent insulinotropic polypeptide (GIP)(up to 5 hours after drinking a glucose load)
  • Sucralose concentrations in plasma(up to 310 min after drinking the sucralose load)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验