Investigating Inter-individual Variability in Glycemic and Insulin Responses

NCT ID: NCT01804738

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-06-30

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.

Conditions

Hyperglycemia; Insulin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Glucose

Glucose anhydrous 50g dissolved in 250ml water

Group Type: NO_INTERVENTION

No interventions assigned to this group

Jasmine rice

50g available carbohydrate portion

Group Type: ACTIVE_COMPARATOR

Jasmine rice

Intervention Type: OTHER

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

Parboiled basmati rice

50g available carbohydrate portion

Group Type: ACTIVE_COMPARATOR

Parboiled basmati rice

Intervention Type: OTHER

Standardised rice:cooking liquid for 50g available carbohydrate portion

Interventions

Jasmine rice

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

Intervention Type: OTHER

Parboiled basmati rice

Standardised rice:cooking liquid for 50g available carbohydrate portion

Intervention Type: OTHER

Other Intervention Names

Dreamrice

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Institute for Human Development and Potential (IHDP), Singapore

OTHER

Sponsor Role: lead

Responsible Party

Lee Yung Seng

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yung S Lee, A/Prof

Role: PRINCIPAL_INVESTIGATOR

Institute for Human Development and Potential (IHDP), Singapore

Locations

Clinical Nutrition Research Centre

Singapore, , Singapore

Countries

Singapore

References

Tan VM, Ooi DS, Kapur J, Wu T, Chan YH, Henry CJ, Lee YS. The role of digestive factors in determining glycemic response in a multiethnic Asian population. Eur J Nutr. 2016 Jun;55(4):1573-81. doi: 10.1007/s00394-015-0976-0. Epub 2015 Jul 10.

Reference Type: RESULT

PMID: 26160548 (View on PubMed)

Tan VM, Wu T, Henry CJ, Lee YS. Glycaemic and insulin responses, glycaemic index and insulinaemic index values of rice between three Asian ethnic groups. Br J Nutr. 2015 Apr 28;113(8):1228-36. doi: 10.1017/S0007114515000586. Epub 2015 Mar 19.

Reference Type: RESULT

PMID: 25789978 (View on PubMed)

Ooi DS, Tan VM, Ong SG, Chan YH, Heng CK, Lee YS. Differences in AMY1 Gene Copy Numbers Derived from Blood, Buccal Cells and Saliva Using Quantitative and Droplet Digital PCR Methods: Flagging the Pitfall. PLoS One. 2017 Jan 26;12(1):e0170767. doi: 10.1371/journal.pone.0170767. eCollection 2017.

Reference Type: RESULT

PMID: 28125683 (View on PubMed)

Other Identifiers

2012/01149

Identifier Type: -

Identifier Source: org_study_id