The Glycaemic Effect of Isomaltulose Consumption in Healthy Participants

Diabetes Mellitus Clinical Trial

Official title:

The Glycaemic Effect of Isomaltulose Consumption in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020485
• Other study ID #: 2014/01008
• Status: Completed
• Phase: N/A
• First received: January 10, 2017
• Last updated: January 11, 2017
• Start date: December 2014
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Isomaltulose
Isomaltulose is a disaccharide made up of one molecule glucose and fructose with a (a1-6) linkage.
• Sucrose
Sucrose is normal table sugar

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in post prandial Blood glucose for 180 minutes period	Blood glucose obtained through finger pricks using Hemocue Glucose Analyser	180 minutes	No