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Energy Flux and Fat Oxidation Using Low and High Glycaemic Index Foods

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ClinicalTrials.gov Identifier: NCT03031886
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obesity PreDiabetes Other: low glycaemic index intervention Other: high glycaemic index intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Double (Participant, Investigator)
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.
Primary Purpose: Other
Official Title: Energy Flux and Fat Oxidation Using Low and High Glycaemic Index Foods
Actual Study Start Date : January 20, 2016
Actual Primary Completion Date : July 21, 2017
Actual Study Completion Date : July 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: high GI
Cereal, milk, tea, cheese, steamed glutinous rice with chicken, carrots, bread, strawberry jam, margarine, high GI sweetener (sucrose).
Other: high glycaemic index intervention
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.

Experimental: Low GI
Cereal, milk, tea, steamed basmati rice with chicken, spinach, bread, strawberry jam, low GI sweetener (isomaltulose).
Other: low glycaemic index intervention
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.




Primary Outcome Measures :
  1. Glycaemic response [ Time Frame: 3 hours post consumption ]
    The blood glucose response to low and high GI test foods measured 2 hours post consumption using the Continuous Glucose Monitoring System (CGMS)

  2. Daily blood glucose profile [ 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 for breakfast, lunch, snack and dinner.

  3. substrate oxidation [ Time Frame: 3 hours post consumption ]
    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.

  4. energy expenditure [ Time Frame: 3 hours post consumption ]
    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.


Other Outcome Measures:
  1. Oxygen consumption [ Time Frame: 3 hours post consumption ]
    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.

  2. carbon dioxide production [ Time Frame: 3 hours post consumption ]
    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.

  3. Nitrogen production [ Time Frame: 10 hours ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   men only
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031886


Locations
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Singapore
Clinical Nutrition Research Centre
Singapore, Singapore, 117599
Sponsors and Collaborators
Clinical Nutrition Research Centre, Singapore
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Responsible Party: JeyaKumar Henry, Principal Investogator, Clinical Nutrition Research Centre, Singapore
ClinicalTrials.gov Identifier: NCT03031886    
Other Study ID Numbers: 2015/01085
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases