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The Metabolic Effects of Consuming Carbohydrate With Different Protein Types

Primary Purpose

Metabolic Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
White rice
Rice with chicken breast
Rice with fish
Rice with egg white
Rice with beancurd
Sponsored by
Clinical Nutrition Research Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metabolic Diseases

Eligibility Criteria

21 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Chinese ethnicity
  • Male
  • Age between 21-40 years
  • Do not have any metabolic diseases (diabetes, hypertension etc)
  • Do not have G6PD deficiency
  • Not on prescription medication known to affect glucose related metabolism
  • Not allergic/intolerant to any of the test foods
  • Do not partake in sports at the competitive and/or endurance levels
  • Weight of at least 45kg
  • Body mass index between 18.0 to 24.9 kg/m2
  • Normal blood pressure (120/80 mmHg)
  • Fasting blood glucose <6.0 mmol/L

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Other

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Rice

    Rice with chicken

    Rice with fish

    Rice with egg white

    Rice with beancurd

    Arm Description

    Control session - white rice (equivalent to 50g available carbohydrates)

    Treatment 1 - White rice and steamed chicken breast (25g protein)

    Treatment 2 - White rice and steamed fish (25g protein)

    Treatment 3 - White rice and egg white (25g protein)

    Treatment 4 - White rice and steamed beancurd (25g protein)

    Outcomes

    Primary Outcome Measures

    Blood glucose response (incremental area under the curve) measured using the hemocue
    Blood glucose response (incremental area under the curve) measured using the hemocue
    Insulin (incremental area under the curve) is determined using the COBAS
    Insulin (incremental area under the curve) is determined using the COBAS
    Glucagon determined using the ELISA
    Glucagon is determined using the ELISA

    Secondary Outcome Measures

    Effects of physical activity
    Self-reported evaluation of physical activity according to a qualitative scale: light, medium or strenuous exercise done the day before the study visit.
    Satiety: Hunger and fullness measured using the Visual analogue scale
    Hunger and fullness measured using the Visual Analogue Scale

    Full Information

    First Posted
    January 28, 2015
    Last Updated
    May 14, 2019
    Sponsor
    Clinical Nutrition Research Centre, Singapore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02380846
    Brief Title
    The Metabolic Effects of Consuming Carbohydrate With Different Protein Types
    Official Title
    The Metabolic Effects of Consuming Carbohydrate With Different Protein Types
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    October 8, 2018 (Actual)
    Study Completion Date
    October 8, 2018 (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
    This study aims to find out how consuming different proteins with rice affect metabolism. Most meals the investigators eat predominantly consist of a carbohydrate and protein (i.e. rice, noodles, bread etc with meats or seafood). However, it is still unknown how consuming different proteins with commonly eaten carbohydrates affect metabolism. Previous studies have shown that proteins stimulate hormones such as insulin, glucagon and gut hormones. However, the extent of the response depends on protein type. The metabolic responses to carbohydrates have also been shown to be greatly affected when they are eaten with proteins. However, most of the previous studies have used glucose as the carbohydrate and it is still unknown how eating proteins with carbohydrate foods such as rice affect metabolism. Therefore, this study has been initiated to determine the metabolic effects of eating different protein types with rice. Using the most common carbohydrate eaten in Asia (rice) and four commonly eaten protein foods (egg, chicken, fish and beancurd), this study aims to observe the metabolic effects of co-ingesting proteins and carbohydrate. The resulting data will provide valuable insights into the metabolic effects of protein-carbohydrate meals and will be useful in the development of practical advice and dietary guidelines for those with chronic diseases (such as diabetes and obesity).
    Detailed Description
    The study will recruit 20 healthy Chinese male subjects from the general public over a period of one year. The test foods will be rice, rice with egg, rice with fish, rice with chicken and rice with beancurd.Potential participants will have to come on one morning in an overnight fasted state for consenting and screening procedures. Only those fulfilling the inclusion and exclusion criteria will be admitted into the study. Each participant will be required to come on 5 non-consecutive days, with each session lasting approximately 4 hours. On each day, participants will arrive at the laboratory between 8-9 am following an overnight fast. An indwelling catheter will be inserted into a vein in their forearm or antecubital fossa and kept patent. Baseline blood samples will be obtained after which they will be given the test food to consume. Further blood samples will be taken at periodic intervals for the subsequent 3.5 hours. Blood samples will be taken every 15 minutes in the first 60 minutes and every 30 minutes for the remaining 150 minutes. At every time point blood samples will be extracted from a finger prick (for measuring glucose) and from the cannula (for measuring all other metabolites). At the same time points subjects will have to fill in visual analogue scales on feelings of hunger and satiety.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Diseases

    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
    Rice
    Arm Type
    Other
    Arm Description
    Control session - white rice (equivalent to 50g available carbohydrates)
    Arm Title
    Rice with chicken
    Arm Type
    Active Comparator
    Arm Description
    Treatment 1 - White rice and steamed chicken breast (25g protein)
    Arm Title
    Rice with fish
    Arm Type
    Active Comparator
    Arm Description
    Treatment 2 - White rice and steamed fish (25g protein)
    Arm Title
    Rice with egg white
    Arm Type
    Active Comparator
    Arm Description
    Treatment 3 - White rice and egg white (25g protein)
    Arm Title
    Rice with beancurd
    Arm Type
    Active Comparator
    Arm Description
    Treatment 4 - White rice and steamed beancurd (25g protein)
    Intervention Type
    Other
    Intervention Name(s)
    White rice
    Intervention Description
    Control - white rice
    Intervention Type
    Other
    Intervention Name(s)
    Rice with chicken breast
    Intervention Description
    Treatment 1 - steamed white rice with steamed chicken breast
    Intervention Type
    Other
    Intervention Name(s)
    Rice with fish
    Intervention Description
    Treatment 2 - steamed white rice with steamed fish
    Intervention Type
    Other
    Intervention Name(s)
    Rice with egg white
    Intervention Description
    Treatment 3 - steamed white rice with egg white
    Intervention Type
    Other
    Intervention Name(s)
    Rice with beancurd
    Intervention Description
    Treatment 4 - steamed white rice with steamed beancurd
    Primary Outcome Measure Information:
    Title
    Blood glucose response (incremental area under the curve) measured using the hemocue
    Description
    Blood glucose response (incremental area under the curve) measured using the hemocue
    Time Frame
    3.5 hours post consumption
    Title
    Insulin (incremental area under the curve) is determined using the COBAS
    Description
    Insulin (incremental area under the curve) is determined using the COBAS
    Time Frame
    3.5 hours post consumption
    Title
    Glucagon determined using the ELISA
    Description
    Glucagon is determined using the ELISA
    Time Frame
    3.5 hours post consumption
    Secondary Outcome Measure Information:
    Title
    Effects of physical activity
    Description
    Self-reported evaluation of physical activity according to a qualitative scale: light, medium or strenuous exercise done the day before the study visit.
    Time Frame
    Assessed at the start of every test session 1-2 weekly and up to 8 weeks in total per subject.
    Title
    Satiety: Hunger and fullness measured using the Visual analogue scale
    Description
    Hunger and fullness measured using the Visual Analogue Scale
    Time Frame
    Assessed at the start of every test session 1-2 weekly and up to 8 weeks in total per subject.

    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 ethnicity Male Age between 21-40 years Do not have any metabolic diseases (diabetes, hypertension etc) Do not have G6PD deficiency Not on prescription medication known to affect glucose related metabolism Not allergic/intolerant to any of the test foods Do not partake in sports at the competitive and/or endurance levels Weight of at least 45kg Body mass index between 18.0 to 24.9 kg/m2 Normal blood pressure (120/80 mmHg) Fasting blood glucose <6.0 mmol/L

    12. IPD Sharing Statement

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    The Metabolic Effects of Consuming Carbohydrate With Different Protein Types

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