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临床试验/NCT01804738
NCT01804738已完成不适用

Investigating Inter-individual Variability in Glycemic and Insulin Responses

Institute for Human Development and Potential (IHDP), Singapore2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2013年3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
75
试验地点
2
主要终点
Postprandial glycemic and insulin responses

研究概览

简要总结

This study aims to test the following hypothesis in healthy lean young men:

  • There are differences in glycemic response (GR) and insulin response (IR) between Chinese, Malay and Asian-Indian
  • There are differences in GI values to the same food between ethnic groups
  • There are ethnic differences postprandial GR and IR for high vs low GI foods
  • Mastication, salivary amylase activity, gastric emptying rate and gut microbiota composition influences inter-individual glycemic and insulinemic variability
  • Ethnic differences in mastication, salivary amylase activity, gastric emptying rate and gut microbiota composition determines the inter-ethnic glycemic and insulinemic variability

详细描述

There is extensive evidence that numerous biological digestive factors varies between individuals and influence postprandial glycemic response (GR) and insulin response (IR), which are well established risk factors that precipitate the development of Type 2 diabetes mellitus (T2DM). However, no study to date has measured and compared physiological parameters such as mastication, salivary amylase activity, gastric emptying rates and gut microbiota in a multi-ethnic Asian population, with varying prevalence of obesity and T2DM. The aim of this study is to investigate ethnic differences in GR and IR as well as the GI values of foods. Additionally, we aim to examine how physiological digestive factors contribute to inter-ethnic and inter-individual variability in GR and IR. The study outcomes can potentially explain, in part, the varying susceptibility to obesity, T2DM and DM control between Chinese, Malays and Asian-Indians in Singapore, as reflected by the differences in prevalence of obesity, T2DM and DM control among the three local ethnic groups.

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
None

入排标准

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

入选标准

  • Be willing and able to comply with study procedures and given written informed consent
  • Chinese/Malay/Indian males, aged 21-40 years old
  • Body mass index (BMI) between 18.5 - 24.9 kg/m2
  • Fasting blood glucose between 4 - 6 mmol/L
  • Sedentary adults, with <1 episode of exercise per week
  • Not have a history of food allergies or food intolerances
  • Be a non-smoker
  • Drinks less than 3 units of alcohol per day
  • Not taking antibiotics for the past 3 weeks

排除标准

  • Subjects with known chronic diseases, including diabetes, untreated hypertension, renal impairment, gastrointestinal problems, and other significant medical conditions
  • BMI <18.5 kg/m2 or >25 kg/m2
  • Fasting blood glucose ≥7.0mmol/l
  • Alcohol consumption >3 drinks / day
  • Use of medications known to affect glucose metabolism
  • Recent changes in weight of >5% over the past 3 months
  • Significant changes in diet over the past 3 months
  • History of eating disorders or irregular eating habits
  • Taking antibiotics medications over the past 3 weeks

研究组 & 干预措施

Glucose

No Intervention

Glucose anhydrous 50g dissolved in 250ml water

Jasmine rice

Active Comparator

50g available carbohydrate portion

干预措施: Jasmine rice (Other)

Parboiled basmati rice

Active Comparator

50g available carbohydrate portion

干预措施: Parboiled basmati rice (Other)

结局指标

主要结局

Postprandial glycemic and insulin responses

时间窗: Every 15 mins in the first hour and every 30 mins for the next 2 hours after food consumption

Capillary bloods will be obtained using finger-pricks

次要结局

  • Physiological digestive functions(Up to 5 hours)

研究者

发起方
Institute for Human Development and Potential (IHDP), Singapore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lee Yung Seng

Associate Professor

Institute for Human Development and Potential (IHDP), Singapore

研究点 (2)

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