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Completed

NCT Number: NCT01804738

Investigating Inter-individual Variability in Glycemic and Insulin Responses

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

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Key information

Age range

21 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Research Centre

Singapore, 117599

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Jasmine rice

Other

Standardised rice:cooking liquid ratio for 50g available carbohydrate portion

Parboiled basmati rice

Other

Standardised rice:cooking liquid for 50g available carbohydrate portion

Other names: Dreamrice

Primary outcomes

  1. Postprandial glycemic and insulin responses

    Time frame: 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

Secondary outcomes

  1. Physiological digestive functions

    Time frame: Up to 5 hours

    They include: measurement of mastication rate, salivary amylase activity, gastric emptying rate and gut microbiota composition

Other outcomes

  1. Glycemic index values

    Time frame: 180 mins

    Derivation of the glycemic index values of foods using postprandial glycemic response to reference food and test foods.

Sponsors and collaborators

Lead sponsor

Institute for Human Development and Potential (IHDP), Singapore

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 5, 2013
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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