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
About this trial
This is an interventional other trial for Metabolic Diseases
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
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
NCT ID
NCT02380846
First Posted
January 28, 2015
Last Updated
May 14, 2019
Sponsor
Clinical Nutrition Research Centre, Singapore
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
Learn more about this trial
The Metabolic Effects of Consuming Carbohydrate With Different Protein Types
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