- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02340507
The Impact of the Glycaemic Index (GI) on Daily Blood Glucose Profiles and Food Intake in Young Chinese Adult Males
March 31, 2015 updated by: JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High glycemic index
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.
|
Rice is a high glycaemic index glutinous rice.
Bread is a high glycaemic index white bread.
|
Experimental: Low glycemic index
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.
|
Rice is a low glycaemic index parboiled basmati rice.
Bread is a low glycaemic index multigrain bread.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycaemic response (measured 3 hours post consumption using the Continuous Glucose Monitoring System (CGMS)
Time Frame: 3 hours post consumption
|
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)
Time Frame: 24 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: Immediately post meal 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
January 7, 2015
First Submitted That Met QC Criteria
January 15, 2015
First Posted (Estimate)
January 16, 2015
Study Record Updates
Last Update Posted (Estimate)
April 1, 2015
Last Update Submitted That Met QC Criteria
March 31, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/00266
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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