Energy Flux and Fat Oxidation Using Low and High Glycaemic Index Foods
Primary Purpose
Type 2 Diabetes, Obesity, PreDiabetes
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
low glycaemic index intervention
high glycaemic index intervention
Sponsored by
About this trial
This is an interventional other trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
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
Sites / Locations
- Clinical Nutrition Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
high GI
Low GI
Arm Description
Cereal, milk, tea, cheese, steamed glutinous rice with chicken, carrots, bread, strawberry jam, margarine, high GI sweetener (sucrose).
Cereal, milk, tea, steamed basmati rice with chicken, spinach, bread, strawberry jam, low GI sweetener (isomaltulose).
Outcomes
Primary Outcome Measures
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)
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03031886
First Posted
January 19, 2017
Last Updated
August 1, 2017
Sponsor
Clinical Nutrition Research Centre, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03031886
Brief Title
Energy Flux and Fat Oxidation Using Low and High Glycaemic Index Foods
Official Title
Energy Flux and Fat Oxidation Using Low and High Glycaemic Index Foods
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 20, 2016 (Actual)
Primary Completion Date
July 21, 2017 (Actual)
Study Completion Date
July 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Nutrition Research Centre, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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. The research sets out to determine the effect of GI on 24 hour blood glucose profiles and energy regulation in Asians. Healthy, normal-weight and overweight, Chinese males will be recruited. There will be two sessions (consisting of three days for each session) where they will consume either a high or low glycaemic index dinner at home and a high or low GI breakfast, lunch and snack on the next day (in the whole body calorimeter). There will be at least five days in between the two sessions. Their glycaemic response will be measured using a Continuous Glucose Monitoring System (CGMS) throughout the period, while substrate oxidation will be measured over 10 hours in the calorimeter (from breakfast, lunch and snack). This study specifically attempts to see whether the inclusion of a low GI sweetener in a mixed meal sequence can impact blood glucose levels and energy regulation in Asians. The study is important in that it will enable us to compute the rate of fat oxidation and how it is influenced when subjects are fed a mixed meals modulated to be high GI (increased glucose excursions) or low GI (moderated glucose) over 24 hours in healthy Asians. Obesity and diabetes rates are increasing exponentially in Asian populations and Singapore is no exception. Devising ways and means to staunch the escalation is therefore a priority. The findings of the research will contribute towards the long-term objectives of developing dietary guidelines for weight and glycaemic control. The study data will also be important for the provision of practical food-based advocacy for better weight and glycaemic control in Asians.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Obesity, PreDiabetes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A randomized,crossover design with either a low or high GI diet with a 5 day washout period in between the 2 interventions..
Masking
ParticipantInvestigator
Masking Description
Double blinded, subjects was blinded from knowing if foods were low or high GI, researchers analyzing the data were blinded from food preparation.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high GI
Arm Type
Experimental
Arm Description
Cereal, milk, tea, cheese, steamed glutinous rice with chicken, carrots, bread, strawberry jam, margarine, high GI sweetener (sucrose).
Arm Title
Low GI
Arm Type
Experimental
Arm Description
Cereal, milk, tea, steamed basmati rice with chicken, spinach, bread, strawberry jam, low GI sweetener (isomaltulose).
Intervention Type
Other
Intervention Name(s)
low glycaemic index intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
high glycaemic index intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycaemic response
Description
The blood glucose response to low and high GI test foods measured 2 hours post consumption using the Continuous Glucose Monitoring System (CGMS)
Time Frame
3 hours post consumption
Title
Daily blood glucose profile
Description
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.
Time Frame
24 hours
Title
substrate oxidation
Description
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.
Time Frame
3 hours post consumption
Title
energy expenditure
Description
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.
Time Frame
3 hours post consumption
Other Pre-specified Outcome Measures:
Title
Oxygen consumption
Description
Oxygen consumption after consumption of low and high GI test foods measured 3 hours postprandial using indirect calorimetry in a whole body calorimeter. This is done over 10 hours in the whole body calorimeter measured for breakfast, lunch and snack only.
Time Frame
3 hours post consumption
Title
carbon dioxide production
Description
Carbon dioxide production after consumption of low and high GI test foods measured 3 hours postprandial using indirect calorimetry in a whole body calorimeter. This is done over 10 hours in the whole body calorimeter measured for breakfast, lunch and snack only.
Time Frame
3 hours post consumption
Title
Nitrogen production
Description
Nitrogen production during 10 hours in the whole body calorimeter is measured from all urine collected during the stay in the whole body calorimeter when consuming low and high GI test foods
Time Frame
10 hours
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
men only
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Facility Information:
Facility Name
Clinical Nutrition Research Centre
City
Singapore
ZIP/Postal Code
117599
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
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Energy Flux and Fat Oxidation Using Low and High Glycaemic Index Foods
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