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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02340507
Other study ID # 2013/00266
Secondary ID
Status Completed
Phase N/A
First received January 7, 2015
Last updated March 31, 2015
Start date May 2013
Est. completion date January 2015

Study information

Verified date March 2015
Source Clinical Nutrition Research Centre, Singapore
Contact n/a
Is FDA regulated No
Health authority Singapore: Domain Specific Review Board
Study type Interventional

Clinical Trial 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.


Description:

The GI is a method of classifying foods based on the food's ability to raise the blood glucose level. Low GI foods are recommended as they have a lower impact on blood glucose concentrations and also reduce total food intake. There is very little information on how eating high and low GI foods affect daily blood glucose concentrations in Asians. Therefore, the objective of this study is to observe the effect of eating high and low GI breakfasts and snacks on 24 hour blood glucose concentrations and food consumption in Asian males. Healthy, normal-weight, Chinese males will be recruited. There will be two sessions (consisting of four days for each session) where they will consume either a high or low GI breakfast or snack, and a standardized ad libitum lunch buffet. Their glycaemic response will be measured using a Continuous Glucose Monitoring System (CGMS) throughout the period. The proposed research for the first time demonstrates how the consumption of high and low GI breakfasts and snacks affect subsequent energy intake and 24 hour blood glucose profiles in Asians. These findings will have significant public health benefits for optimum weight and dietary control.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date January 2015
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 21 Years to 40 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Rice and bread (high GI)
Rice is a high glycaemic index glutinous rice. Bread is a high glycaemic index white bread.
Rice and bread (low GI)
Rice is a low glycaemic index parboiled basmati rice. Bread is a low glycaemic index multigrain bread.

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 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 No
Primary 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 No
Secondary 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) 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 No
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