NCT04653207

Brief Summary

This study will determine the glycaemic and insulinaemic response and sensory profile of the drinks with various ratios sucrose:isomaltulose. The information will be useful for manufacturers of beverages to produce blood glucose friendlier drinks. The information will also be useful for dieticians and clinicians in recommending foods and drinks for people with diabetes. The information will also be useful to the public for making better food choices. The data will also provide insights on how the different ratios of sweeteners may affect glycaemic and insulinaemic indices (GI and II).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
Last Updated

December 23, 2021

Status Verified

December 1, 2021

Enrollment Period

2.7 years

First QC Date

November 27, 2020

Last Update Submit

December 22, 2021

Conditions

Type 2 DiabetesObesityPre Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in postprandial blood glucose over 180 minutes period

    Blood obtained through fingerprick, analysed using Hemocue analyser.

    180 minutes

Secondary Outcomes (1)

  • Change in postprandial plasma insulin over 180 minutes period

    180 minutes

Study Arms (9)

Control 1

OTHER

Glucose 50g

Other: Glucose Solution 1

Control 2

OTHER

Glucose 50g

Other: Glucose Solution 2

Control 3

OTHER

Glucose 50g

Other: Glucose Solution 3

Sucrose/Isomaltulose 100:0

EXPERIMENTAL

A drink with 50g sucrose/isomaltulose 100:0

Other: Sucrose/Isomaltulose 100:0

Sucrose/Isomaltulose 0:100

EXPERIMENTAL

A drink with 50g sucrose/isomaltulose 0:100

Other: Sucrose/Isomaltulose 0:100

Sucrose/Isomaltulose 50:50

EXPERIMENTAL

A drink with 50g sucrose/isomaltulose 50:50

Other: Sucrose/Isomaltulose 50:50

Sucrose/Isomaltulose 60:40

EXPERIMENTAL

A drink with 50g sucrose/isomaltulose 60:40

Other: Sucrose/Isomaltulose 60:40

Sucrose/Isomaltulose 70:30

EXPERIMENTAL

A drink with 50g sucrose/isomaltulose 70:30

Other: Sucrose/Isomaltulose 70:30

Sucrose/Isomaltulose 80:20

EXPERIMENTAL

A drink with 50g sucrose/isomaltulose 80:20

Other: Sucrose/Isomaltulose 80:20

Interventions

Glucose Solution 1OTHER

50g glucose dissolve in 300ml of water

Control 1
Glucose Solution 2OTHER

50g glucose dissolve in 300ml of water

Control 2
Glucose Solution 3OTHER

50g glucose dissolve in 300ml of water

Control 3
Sucrose/Isomaltulose 100:0OTHER

50g sucrose dissolve in 300ml of water

Sucrose/Isomaltulose 100:0
Sucrose/Isomaltulose 0:100OTHER

50g isomaltulose dissolve in 300ml of water

Sucrose/Isomaltulose 0:100
Sucrose/Isomaltulose 50:50OTHER

25g sucrose and 25g isomaltulose dissolve in 300ml of water

Sucrose/Isomaltulose 50:50
Sucrose/Isomaltulose 60:40OTHER

30g sucrose and 20g isomaltulose dissolve in 300ml of water

Sucrose/Isomaltulose 60:40
Sucrose/Isomaltulose 70:30OTHER

35g sucrose and 15g isomaltulose dissolve in 300ml of water

Sucrose/Isomaltulose 70:30
Sucrose/Isomaltulose 80:20OTHER

40g sucrose and 10g isomaltulose dissolve in 300ml of water

Sucrose/Isomaltulose 80:20

Eligibility Criteria

Age21 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAll healthy male participants
Healthy VolunteersYes
Age GroupsAdult (18-64)
* Males * Asian selected from the three ethnicities Malay, Indian and Chinese * Age between 21-60 years * Do not partake in sports at the competitive and/or endurance levels * Body mass index between 22 to 27 kg/m2 * Normal blood pressure (\<140/80 mmHg) * Fasting blood glucose \<6 mmol/L * Do not have an ongoing infection or currently undergoing treatment at the time of screening * Do not have known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV) * Do not have active Tuberculosis (TB) or currently receiving treatment for TB * Not on any concurrent research study/trials * Do not smoke * Do not have any metabolic diseases (such as diabetes, hypertension etc) * Do not have glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency) * Not having medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics) * Do not have intolerances or allergies to foods including the test foods and fructose * Do not partake in sports at the competitive and/or endurance levels * Do not intentionally restrict food intake * Do not have an ongoing infection or currently undergoing treatment at the time of screening * Do not have known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV) * Do not have active Tuberculosis (TB) or currently receiving treatment for TB * Not on any concurrent research study/trials • Do not smoke• Do not have any metabolic diseases (such as diabetes, hypertension etc) * Do not have glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency) * Not having medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)• Do not have intolerances or allergies to foods including the test foods and fructose * Do not partake in sports at the competitive and/or endurance levels * Do not intentionally restrict food intake * Not a team member of the study or is an immediate family member (Immediate family defined as a spouse, parent, child, or sibling, whether biological or legally adopted)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityGlucose Intolerance

Interventions

Sucroseisomaltulose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemia

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized crossover study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2020

First Posted

December 4, 2020

Study Start

March 1, 2018

Primary Completion

October 28, 2020

Study Completion

October 28, 2020

Last Updated

December 23, 2021

Record last verified: 2021-12

Locations

SG(1)