Metabolic DiseasesNCT02380846
The Metabolic Effects of Consuming Carbohydrate With Different Protein Types
A study testing White rice, Rice with chicken breast and Rice with fish in people with Metabolic Diseases, run by Singapore Institute of Food and Biotechnology Innovation.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Diseases
- What is being tested?
- White rice, Rice with chicken breast and Rice with fish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to 8 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
About this study
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).
Read the 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.
- Conditions
- Metabolic Diseases
- Being tested
- White rice, Rice with chicken breast, Rice with fish, Rice with egg white, Rice with beancurd
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White riceOther
Control - white rice
Rice with chicken breastOther
Treatment 1 - steamed white rice with steamed chicken breast
Rice with fishOther
Treatment 2 - steamed white rice with steamed fish
Rice with egg whiteOther
Treatment 3 - steamed white rice with egg white
Rice with beancurdOther
Treatment 4 - steamed white rice with steamed beancurd
| Study group | Role | What they receive |
|---|---|---|
| Rice | Other | Control session - white rice (equivalent to 50g available carbohydrates) Receives: Other: White rice |
| Rice with chicken | Active comparator | Treatment 1 - White rice and steamed chicken breast (25g protein) Receives: Other: Rice with chicken breast |
| Rice with fish | Active comparator | Treatment 2 - White rice and steamed fish (25g protein) Receives: Other: Rice with fish |
| Rice with egg white | Active comparator | Treatment 3 - White rice and egg white (25g protein) Receives: Other: Rice with egg white |
| Rice with beancurd | Active comparator | Treatment 4 - White rice and steamed beancurd (25g protein) Receives: Other: Rice with beancurd |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose response (incremental area under the curve) measured using the hemocue
Blood glucose response (incremental area under the curve) measured using the hemocue
Measured: 3.5 hours post consumption
Insulin (incremental area under the curve) is determined using the COBAS
Insulin (incremental area under the curve) is determined using the COBAS
Measured: 3.5 hours post consumption
Glucagon determined using the ELISA
Glucagon is determined using the ELISA
Measured: 3.5 hours post consumption
Secondary outcomes (2)
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.
Measured: 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
Hunger and fullness measured using the Visual Analogue Scale
Measured: Assessed at the start of every test session 1-2 weekly and up to 8 weeks in total per subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startSep 2013
- Primary completion8 Oct 2018
- Study completion8 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Melvin Leow, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380846
- Sponsor's protocol ID
- 2013/00589
- Status last verified
- May 2019
- First submitted
- 28 Jan 2015
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Effects of Consuming Carbohydrate With Different Protein Types
- ClinicalTrials.gov ID
- NCT02380846
- Acronym / sponsor ID
- 2013/00589
- Conditions
- Metabolic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- Sep 2013
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Rice | Other | Other: White riceControl session - white rice (equivalent to 50g available carbohydrates) |
| Rice with chicken | Active comparator | Other: Rice with chicken breastTreatment 1 - White rice and steamed chicken breast (25g protein) |
| Rice with fish | Active comparator | Other: Rice with fishTreatment 2 - White rice and steamed fish (25g protein) |
| Rice with egg white | Active comparator | Other: Rice with egg whiteTreatment 3 - White rice and egg white (25g protein) |
| Rice with beancurd | Active comparator | Other: Rice with beancurdTreatment 4 - White rice and steamed beancurd (25g protein) |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Chinese ethnicity
- Male
- Age between 21-40 years
- Do not have any metabolic diseases (diabetes, hypertension etc)
- Do not have G6PD deficiency
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White riceControl - white rice | Other | Rice |
| Rice with chicken breastTreatment 1 - steamed white rice with steamed chicken breast | Other | Rice with chicken |
| Rice with fishTreatment 2 - steamed white rice with steamed fish | Other | Rice with fish |
| Rice with egg whiteTreatment 3 - steamed white rice with egg white | Other | Rice with egg white |
| Rice with beancurdTreatment 4 - steamed white rice with steamed beancurd | Other | Rice with beancurd |
Primary outcome
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
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
Glucagon determined using the ELISA
Time frame: 3.5 hours post consumption
Glucagon is determined using the ELISA
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
Related trials for Metabolic Diseases
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing White rice, Rice with chicken breast and Rice with fish in people with Metabolic Diseases, run by Singapore Institute of Food and Biotechnology Innovation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose response (incremental area under the curve) measured using the hemocue (time frame: 3.5 hours post consumption). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.