The Glycaemic Effect of Isomaltulose Consumption in Healthy Participants

January 11, 2017 updated by: Melvin Leow, Clinical Nutrition Research Centre, Singapore
The objective of this study is to determine the glycaemic effect of isomaltulose and sucrose in Chinese, Indian, Malay, and Caucasian individuals. The current study will provide important information on the potential health benefits of isomaltulose consumption in Asian population. It will also reveal how the three main ethnicities in Singapore respond to isomaltulose and whether the response differs from the Caucasians.

Study Overview

Status

Completed

Conditions

Detailed Description

The objective of the present study is to investigate the glycaemic effect of isomaltulose in Chinese, Indians, Malays and Caucasians. This will be a single intervention. Up to fifty participants, consisting of at least ten Chinese, ten Malays, ten Indians, and ten Caucasians completed data sets, aged between 21 and 40 years will be recruited from the general public in Singapore. Participants will be asked to attend two test sessions for this study. Participants will consume either a sucrose drink or an isomaltulose drink (each containing 50 g of available carbohydrate).

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

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

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chinese, Indian, Malay or Caucasian ethnic origin

Exclusion Criteria:

  • People with major chronic disease such as heart disease, cancer or diabetes mellitus
  • Individuals with food intolerances or allergies to isomaltulose or sucrose
  • Individuals who are taking insulin or drugs known to affect glucose metabolism and body fat distribution
  • People with a major medical or surgical event requiring hospitalization within the preceding 3 months
  • Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
  • Pregnant women

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Isomaltulose
50g of isomaltulose dissolved in 250ml of water
Isomaltulose is a disaccharide made up of one molecule glucose and fructose with a (α1-6) linkage.
Experimental: Sucrose
50g of sucrose dissolved in 250ml of water
Sucrose is normal table sugar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in post prandial Blood glucose for 180 minutes period
Time Frame: 180 minutes
Blood glucose obtained through finger pricks using Hemocue Glucose Analyser
180 minutes

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Melvin Leow, MD, Clinical Nutrition Research Centre

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

December 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2014/01008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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