The Glycaemic Effect of Isomaltulose Consumption in Healthy Participants

NCT ID: NCT03020485

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-09-30

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.

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).

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

Isomaltulose

50g of isomaltulose dissolved in 250ml of water

Group Type: EXPERIMENTAL

Isomaltulose

Intervention Type: OTHER

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

Sucrose

50g of sucrose dissolved in 250ml of water

Group Type: EXPERIMENTAL

Sucrose

Intervention Type: OTHER

Sucrose is normal table sugar

Interventions

Isomaltulose

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

Intervention Type: OTHER

Sucrose

Sucrose is normal table sugar

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Singapore Institute of Food and Biotechnology Innovation

OTHER_GOV

Sponsor Role: lead

Responsible Party

Melvin Leow

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melvin Leow, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Nutrition Research Centre

Other Identifiers

2014/01008

Identifier Type: -

Identifier Source: org_study_id