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临床试验/NCT05399134
NCT05399134已完成不适用

Glycemic Evaluation of Novel Staple Foods

National University of Singapore2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Postprandial glycemic response of novel staple foods in Type 2 diabetics

研究概览

简要总结

In this study, the combined effects of functional foods (i.e. Anthocyanin fortified bread, Microfluidic co-flow noodles, 5ibrePlus™-fortified white rice) is investigated in an ad-libitum diet and their contributions to diabetes management.

详细描述

Research has confirmed that a food's glycemic effect cannot be accurately predicted from the type and amount of carbohydrates it contains, as the rate at which the carbohydrates is digested and released into the bloodstream is influenced by many factors such as the food's physical form, its fat, protein and fibre content, and the chemical structure of its carbohydrates. For these reasons, it is possible to produce food from the same group with different effects on blood glucose. Consumption of low GI food has shown to improve glycemic control, lipid profile and reduce systemic inflammation. With bread, noodles and rice being the staple food for many Singaporeans, functional staple food alternatives offer a lower GI alternative without greatly affecting the population's dietary preference. Preliminary studies for each functional staple food alternative (for bread, noodles, and rice) had reflected improved glycaemic responses compared to their staple counterparts.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chinese ethnicity
  • English-speaking
  • Age between 21 - 70 years old inclusive.
  • Confirmed Type 2 Diabetes with HbA1c level of less than 10%
  • Not on prandial insulin therapy
  • Subjects with stable medical problems not limited to hypertension and hyperlipidemia

排除标准

  • Current smoker or use of tobacco products within the 3 months
  • Vegetarian or other dietary restrictions that would not allow the subject to consume the test meal.
  • Persons with electronic medical implants (e.g. pacemaker).
  • Persons with known or ongoing psychiatric disorders or drug abuse within 3 years.
  • Women who are pregnant or lactating.
  • Persons with an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females). 1 unit is equivalent to:
  • 12 oz or 360 mL of beer;
  • 5 oz or 150 mL of wine;
  • 1.5 oz or 45 mL of distilled spirits.
  • Persons with active infection(s) requiring systemic, antiviral or antimicrobial therapy that will not be completed prior to the first study visit
  • Persons who have undergone treatment with any investigational drug or biological agent within one (1) month of screening or plans to enroll in another study involving investigational drugs/biological agents during the duration of this study.
  • Persons with significant change in weight (+/- 5%) during the past month.
  • Persons with a known allergy to rice bran, dietary fiber, alginate and other study components (anthocyanins, soy protein).

结局指标

主要结局

Postprandial glycemic response of novel staple foods in Type 2 diabetics

时间窗: 5 weeks

Incremental area under the curve (iAUC) post prandial glycemic response from continuous glucose monitoring of diet incorporated with novel staple foods, in comparison to control staple foods, in Type 2 diabetic individuals.

次要结局

未报告次要终点

研究者

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

Mei Hui Liu

Co-Investigator

National University of Singapore

研究点 (2)

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