Investigating Inter-individual Variability in Glycemic and Insulin Responses

March 12, 2019 updated by: Lee Yung Seng, Singapore Institute for Clinical Sciences

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117599
        • Clinical Nutrition Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Glucose
Glucose anhydrous 50g dissolved in 250ml water
ACTIVE_COMPARATOR: Jasmine rice
50g available carbohydrate portion
Other: Jasmine rice
Standardised rice:cooking liquid ratio for 50g available carbohydrate portion
ACTIVE_COMPARATOR: Parboiled basmati rice
50g available carbohydrate portion
Other: Parboiled basmati rice
Standardised rice:cooking liquid for 50g available carbohydrate portion
Other Names:
  • Dreamrice

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Every 15 mins in the first hour and every 30 mins for the next 2 hours after food consumption

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Up to 5 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
180 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Singapore Institute for Clinical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yung S Lee, A/Prof, Singapore Institute for Clinical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012/01149

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