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Investigating Inter-individual Variability in Glycemic and Insulin Responses

Primary Purpose

Hyperglycemia, Insulin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Jasmine rice
Parboiled basmati rice
Sponsored by
Singapore Institute for Clinical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperglycemia focused on measuring Ethnic differences, Inter-individual variability, Glycemic response, Insulin response, Mastication, Salivary alpha-amylase, Gastric emptying, Metagenome

Eligibility Criteria

21 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Nutrition Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Glucose

Jasmine rice

Parboiled basmati rice

Arm Description

Glucose anhydrous 50g dissolved in 250ml water

50g available carbohydrate portion

50g available carbohydrate portion

Outcomes

Primary Outcome Measures

Postprandial glycemic and insulin responses
Capillary bloods will be obtained using finger-pricks

Secondary Outcome Measures

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

Full Information

First Posted
March 4, 2013
Last Updated
March 12, 2019
Sponsor
Singapore Institute for Clinical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01804738
Brief Title
Investigating Inter-individual Variability in Glycemic and Insulin Responses
Official Title
Investigating Inter-individual Variability in Glycemic and Insulin Responses
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore Institute for Clinical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Insulin Sensitivity
Keywords
Ethnic differences, Inter-individual variability, Glycemic response, Insulin response, Mastication, Salivary alpha-amylase, Gastric emptying, Metagenome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose
Arm Type
No Intervention
Arm Description
Glucose anhydrous 50g dissolved in 250ml water
Arm Title
Jasmine rice
Arm Type
Active Comparator
Arm Description
50g available carbohydrate portion
Arm Title
Parboiled basmati rice
Arm Type
Active Comparator
Arm Description
50g available carbohydrate portion
Intervention Type
Other
Intervention Name(s)
Jasmine rice
Intervention Description
Standardised rice:cooking liquid ratio for 50g available carbohydrate portion
Intervention Type
Other
Intervention Name(s)
Parboiled basmati rice
Other Intervention Name(s)
Dreamrice
Intervention Description
Standardised rice:cooking liquid for 50g available carbohydrate portion
Primary Outcome Measure Information:
Title
Postprandial glycemic and insulin responses
Description
Capillary bloods will be obtained using finger-pricks
Time Frame
Every 15 mins in the first hour and every 30 mins for the next 2 hours after food consumption
Secondary Outcome Measure Information:
Title
Physiological digestive functions
Description
They include: measurement of mastication rate, salivary amylase activity, gastric emptying rate and gut microbiota composition
Time Frame
Up to 5 hours
Other Pre-specified Outcome Measures:
Title
Glycemic index values
Description
Derivation of the glycemic index values of foods using postprandial glycemic response to reference food and test foods.
Time Frame
180 mins

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung S Lee, A/Prof
Organizational Affiliation
Singapore Institute for Clinical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Nutrition Research Centre
City
Singapore
ZIP/Postal Code
117599
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
26160548
Citation
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.
Results Reference
result
PubMed Identifier
25789978
Citation
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.
Results Reference
result
PubMed Identifier
28125683
Citation
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.
Results Reference
result

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Investigating Inter-individual Variability in Glycemic and Insulin Responses

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