NCT02340507

Brief Summary

This study is carried out to find out the inclusion of high and low glycaemic Index (GI) foods to daily meals impact on 24 hour blood glucose fluctuations and food intake.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started May 2013

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

May 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

January 7, 2015

Last Update Submit

March 31, 2015

Conditions

Type 2 DiabetesObesityPrediabetes

Outcome Measures

Primary Outcomes (2)

  • Glycaemic response (measured 3 hours post consumption using the Continuous Glucose Monitoring System (CGMS)

    The blood glucose response to low and high GI test foods measured 3 hours post consumption using the Continuous Glucose Monitoring System (CGMS)

    3 hours post consumption

  • Daily blood glucose profile (easured for each low and high GI treatment as the area under the curve over 24 hours using CGMS)

    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.

    24 hours

Secondary Outcomes (1)

  • Energy intake (The amount of food consumed at the ad libitum lunch is measured by weighed quantities (in grams converted to kilocalories) based on the difference of the weight of food before and after consumption)

    Immediately post meal consumption

Study Arms (2)

High glycemic index

EXPERIMENTAL

The subject will consume a high glycemic index glutinous rice for breakfast (75g available carbohydrates), and a high glycemic index white bread for snack (25g available carbohydrates). The lunch is a standardized, weighed portion buffet.

Other: Rice and bread (high GI)

Low glycemic index

EXPERIMENTAL

The subject will consume a low glycemic index parboiled basmati rice for breakfast (75g available carbohydrates), and a low glycemic index multigrain bread for snack (25g available carbohydrates). The lunch is a standardized, weighed portion buffet.

Other: Rice and bread (low GI)

Interventions

Rice and bread (high GI)OTHER

Rice is a high glycaemic index glutinous rice. Bread is a high glycaemic index white bread.

High glycemic index
Rice and bread (low GI)OTHER

Rice is a low glycaemic index parboiled basmati rice. Bread is a low glycaemic index multigrain bread.

Low glycemic index

Eligibility Criteria

Age21 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese, male
  • Age between 21-40 years
  • Body mass index between 17 to 24 kg/m2
  • Normal blood pressure (120/80 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

Related Publications (1)

  • Kaur B, Ranawana V, Teh AL, Henry CJK. The impact of a low glycemic index (GI) breakfast and snack on daily blood glucose profiles and food intake in young Chinese adult males. J Clin Transl Endocrinol. 2015 Jun 11;2(3):92-98. doi: 10.1016/j.jcte.2015.05.002. eCollection 2015 Sep.

    PMID: 29204372DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityPrediabetic State

Interventions

Bread

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

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

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 16, 2015

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

January 1, 2015

Last Updated

April 1, 2015

Record last verified: 2015-03