- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03020485
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
Intervention / Treatment
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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