- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02380846
The Metabolic Effects of Consuming Carbohydrate With Different Protein Types
May 14, 2019 updated by: Melvin Leow, Clinical Nutrition Research Centre, Singapore
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).
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Rice
Control session - white rice (equivalent to 50g available carbohydrates)
|
Control - white rice
|
Active Comparator: Rice with chicken
Treatment 1 - White rice and steamed chicken breast (25g protein)
|
Treatment 1 - steamed white rice with steamed chicken breast
|
Active Comparator: Rice with fish
Treatment 2 - White rice and steamed fish (25g protein)
|
Treatment 2 - steamed white rice with steamed fish
|
Active Comparator: Rice with egg white
Treatment 3 - White rice and egg white (25g protein)
|
Treatment 3 - steamed white rice with egg white
|
Active Comparator: Rice with beancurd
Treatment 4 - White rice and steamed beancurd (25g protein)
|
Treatment 4 - steamed white rice with steamed beancurd
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood glucose response (incremental area under the curve) measured using the hemocue
Time Frame: 3.5 hours post consumption
|
Blood glucose response (incremental area under the curve) measured using the hemocue
|
3.5 hours post consumption
|
Insulin (incremental area under the curve) is determined using the COBAS
Time Frame: 3.5 hours post consumption
|
Insulin (incremental area under the curve) is determined using the COBAS
|
3.5 hours post consumption
|
Glucagon determined using the ELISA
Time Frame: 3.5 hours post consumption
|
Glucagon is determined using the ELISA
|
3.5 hours post consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of physical activity
Time Frame: Assessed at the start of every test session 1-2 weekly and up to 8 weeks in total per subject.
|
Self-reported evaluation of physical activity according to a qualitative scale: light, medium or strenuous exercise done the day before the study visit.
|
Assessed at the start of every test session 1-2 weekly and up to 8 weeks in total per subject.
|
Satiety: 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.
|
Hunger and fullness measured using the Visual Analogue Scale
|
Assessed at the start of every test session 1-2 weekly and up to 8 weeks in total per subject.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
October 8, 2018
Study Completion (Actual)
October 8, 2018
Study Registration Dates
First Submitted
January 28, 2015
First Submitted That Met QC Criteria
March 2, 2015
First Posted (Estimate)
March 5, 2015
Study Record Updates
Last Update Posted (Actual)
May 15, 2019
Last Update Submitted That Met QC Criteria
May 14, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/00589
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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