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临床试验/NCT02607345
NCT02607345已完成不适用

25gr. Glucomedics vs 25gr. Zusto

Bart Keymeulen0 个研究点目标入组 10 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
主要终点
the difference in glycemic index between 25gr. Zusto® and 25gr. Glucomedics®

研究概览

简要总结

Objective: to compare blood glucose and insulin responses after consumption of 100ml water, sweetened with 25gr Zusto® and 100ml water sweetened with 25gr Glucomedics® (standard drink)

详细描述

This is an experimental study enrolling 10 healthy female subjects. The study compares the blood glucose and insulin responses after consumption of 100ml water, sweetened with 25gr Zusto® and 100ml water sweetened with 25gr Glucomedics® (standard drink). Subjects need to be fasted for at least 8 hours before all visits. At visit 1, five women will consume the solution with 25gr Zusto®, the other five will have the solution with 25gr Glucomedics®. On visit 2, groups will be switched. Visit 1 and 2 will be performed within approximately one week interval.

Both drinks will be identical in amount of water and only be different by the use of 25gr Glucomedics® and 25gr Zusto®.

Before intake of the drink, vital signs, weight and bedside blood glucose and baseline blood samples - 15' and 0' for glucose, insulin and C-peptide will be taken at visit 1 and 2. Both drinks will be consumed within 5 minutes and time of start and end of intake of Zusto® / Glucomedics® will be documented.

Blood samples for glucose, insulin and C-peptide will be taken at 15', 30', 60', 90', 120' and 180' after start of intake 25gr Zusto® and 25gr Glucomedics®.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Female subjects
  • •Age between 30 and 50 years
  • •BMI between 20 and 30 kg/m²

排除标准

  • •No first degree relatives with mellitus type 1 or type 2
  • •No intake of medication with influence blood glucose levels
  • •Pregnant, breast feeding or planning to become pregnant during the study
  • •Employer of the investigator or study center with direct involvement in the proposed study or other studies under the direction of the investigator or study center

研究组 & 干预措施

Glucomedics®

Active Comparator

25gr Glucomedics®

干预措施: Glucomedics® (Dietary Supplement)

Zusto®

Experimental

25gr Zusto®

干预措施: Zusto (Dietary Supplement)

结局指标

主要结局

the difference in glycemic index between 25gr. Zusto® and 25gr. Glucomedics®

时间窗: 1 month

GI values will be calculated using the iAUC of Zusto® intake and Glucomedics® intake.

次要结局

未报告次要终点

研究者

发起方
Bart Keymeulen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bart Keymeulen

MD PhD

AZ-VUB

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