The Influence of Glucose Flux on Fat Synthesis in a Whole Body Calorimeter
Primary Purpose
Type 2 Diabetes, Obesity, Prediabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Breakfast, lunch, snack and dinner
Sponsored by
About this trial
This is an interventional other trial for Type 2 Diabetes, Obesity, Prediabetes
Eligibility Criteria
Inclusion Criteria:
- Chinese, male
- Age between 21-40 years
- Body mass index between 17 to 25 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)
- On prescription medication
- Having glucose 6-phosphate dehydrogenase deficiency (G6PD)
- 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Breakfast, lunch, snack and dinner (high GI)
Breakfast, lunch, snack and dinner (low GI)
Arm Description
Subjects will consume meals which are high glycemic index for breakfast (Honey stars cereal), lunch (glutinous rice meal) and snack (white bread and jam) in the whole body calorimeter. A take-away high glycemic index dinner will be provided.
Subjects will consume meals which are low glycemic index for breakfast (All bran cereal), lunch (basmati rice meal) and snack (multigrain bread and sugar-free jam) in the whole body calorimeter. A take-away low glycemic index dinner will be provided.
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)
The blood glucose response to low and high GI test foods measured 2 hours post consumption using the Continuous Glucose Monitoring System (CGMS)
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
The carbohydrate and fat oxidation (i.e Respiratory Quotient) after consumption of low and high GI test foods measured 2 hours post consumption 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
Secondary Outcome Measures
Full Information
NCT ID
NCT02631083
First Posted
December 11, 2015
Last Updated
August 1, 2017
Sponsor
Clinical Nutrition Research Centre, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT02631083
Brief Title
The Influence of Glucose Flux on Fat Synthesis in a Whole Body Calorimeter
Official Title
The Impact of a Low Glycaemic Index (GI) Diet on Daily Blood Glucose Profiles and Energy Flux in Male Chinese Adults.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 14, 2014 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Nutrition Research Centre, Singapore
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is carried out to find out the inclusion of high and low glycaemic index foods to daily meals and how they impact 24 hour blood glucose fluctuations and energy regulation.
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, 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, lunch, snack (in the whole body calorimeter), and a high or low glycaemic index dinner at home. They will take part in two test sessions (each spanning over 3 days) with 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 how having high and low GI meals impact on blood glucose levels and energy regulation in Asians. The study is important in that it will be the first of its kind in the whole body calorimeter and enable us to compute the rate of fat synthesis and how it is modulated when subjects are fed a high GI diet (increased glucose excursions) and a low GI diet ( blunted 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 Asian specific 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 Singaporeans.
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breakfast, lunch, snack and dinner (high GI)
Arm Type
Experimental
Arm Description
Subjects will consume meals which are high glycemic index for breakfast (Honey stars cereal), lunch (glutinous rice meal) and snack (white bread and jam) in the whole body calorimeter. A take-away high glycemic index dinner will be provided.
Arm Title
Breakfast, lunch, snack and dinner (low GI)
Arm Type
Experimental
Arm Description
Subjects will consume meals which are low glycemic index for breakfast (All bran cereal), lunch (basmati rice meal) and snack (multigrain bread and sugar-free jam) in the whole body calorimeter. A take-away low glycemic index dinner will be provided.
Intervention Type
Other
Intervention Name(s)
Breakfast, lunch, snack and dinner
Intervention Description
These meals (cereal, rice and bread meals) will be tested in subjects for their glycaemic response (CGMS) and substrate utilization (calorimeter)
Primary Outcome Measure Information:
Title
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)
Description
The blood glucose response to low and high GI test foods measured 2 hours post consumption using the Continuous Glucose Monitoring System (CGMS)
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
2 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
The carbohydrate and fat oxidation (i.e Respiratory Quotient) after consumption of low and high GI test foods measured 2 hours post consumption 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
2 hours post consumption
10. Eligibility
Sex
Male
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 25 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)
On prescription medication
Having glucose 6-phosphate dehydrogenase deficiency (G6PD)
Partaking in sports at the competitive and/or endurance levels
Allergic/intolerant to any of the test foods
Intentionally restricting food intake
Smoking
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data
Citations:
PubMed Identifier
28701162
Citation
Camps SG, Kaur B, Quek RYC, Henry CJ. Does the ingestion of a 24 hour low glycaemic index Asian mixed meal diet improve glycaemic response and promote fat oxidation? A controlled, randomized cross-over study. Nutr J. 2017 Jul 12;16(1):43. doi: 10.1186/s12937-017-0258-1.
Results Reference
derived
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The Influence of Glucose Flux on Fat Synthesis in a Whole Body Calorimeter
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