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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
Clinical Nutrition Research Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes, Obesity, Prediabetes

Eligibility Criteria

21 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

    First Posted
    December 11, 2015
    Last Updated
    August 1, 2017
    Sponsor
    Clinical Nutrition Research Centre, Singapore
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    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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