NCT03020485

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

January 10, 2017

Last Update Submit

January 11, 2017

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change in post prandial Blood glucose for 180 minutes period

    Blood glucose obtained through finger pricks using Hemocue Glucose Analyser

    180 minutes

Study Arms (2)

Isomaltulose

EXPERIMENTAL

50g of isomaltulose dissolved in 250ml of water

Other: Isomaltulose

Sucrose

EXPERIMENTAL

50g of sucrose dissolved in 250ml of water

Other: Sucrose

Interventions

IsomaltuloseOTHER

Isomaltulose is a disaccharide made up of one molecule glucose and fructose with a (α1-6) linkage.

Isomaltulose
SucroseOTHER

Sucrose is normal table sugar

Sucrose

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese, Indian, Malay or Caucasian ethnic origin

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

isomaltuloseSucrose

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Melvin Leow, MD

    Clinical Nutrition Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 13, 2017

Study Start

December 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 13, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share