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Investigating Inter-individual Variability in Glycemic and Insulin Responses

Investigating Inter-individual Variability in Glycemic and Insulin Responses

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01804738
Enrollment
75
Registered
2013-03-05
Start date
2013-03-31
Completion date
2014-06-30
Last updated
2019-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia, Insulin Sensitivity

Keywords

Ethnic differences, Inter-individual variability, Glycemic response, Insulin response, Mastication, Salivary alpha-amylase, Gastric emptying, Metagenome

Brief summary

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

Detailed description

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.

Interventions

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

OTHERParboiled basmati rice

Standardised rice:cooking liquid for 50g available carbohydrate portion

Sponsors

Institute for Human Development and Potential (IHDP), Singapore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
21 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postprandial glycemic and insulin responsesEvery 15 mins in the first hour and every 30 mins for the next 2 hours after food consumptionCapillary bloods will be obtained using finger-pricks

Secondary

MeasureTime frameDescription
Physiological digestive functionsUp to 5 hoursThey include: measurement of mastication rate, salivary amylase activity, gastric emptying rate and gut microbiota composition

Other

MeasureTime frameDescription
Glycemic index values180 minsDerivation of the glycemic index values of foods using postprandial glycemic response to reference food and test foods.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026