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临床试验/NCT04494607
NCT04494607Unknown不适用

Evaluation of the Glycemic Index of Various Types of Pasta in Healthy Volunteers

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis0 个研究点目标入组 12 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
12
主要终点
Glycemic Index determination

研究概览

简要总结

he project aims to evaluate the glycemic index of different types of pasta with different formats and with different types of flour. In particular, we want to know the effect of the format and the different type of flour on the glycemic and insulinemic response.

Specific objective 1: determination of the glycemic index of the product concerned.

Specific objective 2: determination of the insulinemic index of the product concerned.

Specific objective 3: determination of the pasta format and the type of flour with a lower glycemic and insulinemic index.

详细描述

The study is divided into the following phases:

Phase 1: screening of subjects aimed at identifying possession of the inclusion criteria necessary for participation in the study;

Phase 2: Enrollment of the subject and for each of the enlisted subjects, execution of the first and second determination of the glycemic and insulinemic response curve with the standard glucose solution 30 days apart; 15 days after the second determination of the glycemic and insulinemic response to the glucose load, the assumption of the food test will be performed on which to measure the glycemic index (type of pasta) and evaluation of the glycemic and insulinemic response curve to this food ; finally, after a further 30 days, the third determination of the glycemic and insulinemic response curve will be performed with the standard glucose solution;

Phase 3: statistical processing of the results of phase 2 and determination of the glycemic index and insulinemic index for each type of pasta tested;

Phase 4: description of the results of phase 3 with indication to the supplier company of the pasta format and the type of flour with lower glycemic and insulinemic index.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects
  • No carbohydrate intolerance or diabetes

排除标准

  • Intolerance ascertained to the products in study (celiac syndrome)

结局指标

主要结局

Glycemic Index determination

时间窗: 1 year

determination of the glycemic index for the product in study

次要结局

  • Insulinemic Index determination(1 year)

研究者

发起方
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Gabriella Caruso

M.D

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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