NCT03031886

Brief Summary

Purpose: This study is carried out to determine the effect of GI on 24 hour blood glucose profiles and energy regulation in Asians when fed a normal diet modulated with sweeteners.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2016

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

January 20, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2017

Completed
Last Updated

August 2, 2017

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

January 19, 2017

Last Update Submit

August 1, 2017

Conditions

Type 2 DiabetesObesityPreDiabetes

Outcome Measures

Primary Outcomes (4)

  • Glycaemic response

    The blood glucose response to low and high GI test foods measured 2 hours post consumption using the Continuous Glucose Monitoring System (CGMS)

    3 hours post consumption

  • Daily blood glucose profile

    The daily total blood glucose response is measured for each low and high GI treatment as the area under the curve over 24 hours using CGMS for breakfast, lunch, snack and dinner.

    24 hours

  • substrate oxidation

    Carbohydrate, fat and protein oxidation and respiratory quotient after consumption of low and high GI test foods are calculated for the 3 hours postprandial after breakfast, lunch and snack. These are calculated from the oxygen consumption, carbon dioxide production and nitrogen production. These sub-measurements are specified under: Other Pre-specified Outcomes: Oxygen consumption, carbon dioxide production, nitrogen production.

    3 hours post consumption

  • energy expenditure

    Energy expenditure after consumption of low and high GI test foods is calculated for the 3 hours postprandial after breakfast, lunch and snack. This is calculated from the oxygen consumption and carbon dioxide production. These sub-measurements are specified under: Other Pre-specified Outcomes: Oxygen consumption, carbon dioxide production.

    3 hours post consumption

Other Outcomes (3)

  • Oxygen consumption

    3 hours post consumption

  • carbon dioxide production

    3 hours post consumption

  • Nitrogen production

    10 hours

Study Arms (2)

high GI

EXPERIMENTAL

Cereal, milk, tea, cheese, steamed glutinous rice with chicken, carrots, bread, strawberry jam, margarine, high GI sweetener (sucrose).

Other: high glycaemic index intervention

Low GI

EXPERIMENTAL

Cereal, milk, tea, steamed basmati rice with chicken, spinach, bread, strawberry jam, low GI sweetener (isomaltulose).

Other: low glycaemic index intervention

Interventions

low glycaemic index interventionOTHER

Low GI sweetener would be added to the treatment meals. 30 grams of isomaltulose to dinner and breakfast and 20 grams of isomaltulose to lunch and snack.

Low GI
high glycaemic index interventionOTHER

High GI sweetener would be added to the treatment meals. 30 grams of sucrose to dinner and breakfast and 20 grams of sucrose to lunch and snack.

high GI

Eligibility Criteria

Age21 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmen only
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese, male
  • Age between 21-40 years
  • Body mass index between 17 to 28 kg/m2
  • Normal blood pressure (\<140/80 Hgmm)
  • Fasting blood glucose \< 6 mmol/L

You may not qualify if:

  • Having any metabolic diseases (such as diabetes, hypertension etc)
  • One prescription medication
  • Partaking in sports at the competitive and/or endurance levels
  • Allergic/intolerant to any of the test foods
  • Intentionally restricting food intake
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityPrediabetic State

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blinded, subjects was blinded from knowing if foods were low or high GI, researchers analyzing the data were blinded from food preparation.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: A randomized,crossover design with either a low or high GI diet with a 5 day washout period in between the 2 interventions..
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investogator

Study Record Dates

First Submitted

January 19, 2017

First Posted

January 26, 2017

Study Start

January 20, 2016

Primary Completion

July 21, 2017

Study Completion

July 21, 2017

Last Updated

August 2, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)