Metabolic DiseasesNCT02455765
Glycemic Response of Co-ingesting Carbohydrate and Amino Acids
A study testing Rice and Amino Acid mixtures in people with Metabolic Diseases, run by Singapore Institute of Food and Biotechnology Innovation.
Trial summary
The study will investigate if consumption of amino acid mixtures results a change in glycemic response of carbohydrate (white rice) and insulinemic response at different doses and timing (before consumption of carbohydrate). Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Diseases
- What is being tested?
- Rice and Amino Acid mixtures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Oct 2015
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Chinese ethnicity
- Age between 21-50 years
- Body mass index (BMI) between 18-24.9 kg/m2
- Waist circumference ≤ 90 cm for men
- Normal blood pressure (<120/80 mmHg)
- Fasting blood glucose < 6 mmol/L
Who cannot join
- dislike the consumption of Essence of Chicken
- participating in competitive sports
- allergic to amino acids and rice
- metabolic diseases (such as diabetes, hypertension and the metabolic syndromes)
- Glucose-6-Phosphate-Dehydrogenase (G6PD) Deficiency
- on prescription medication
- smokers
About this study
The study will investigate if consumption of amino acid mixtures results a change in glycemic response of carbohydrate (white rice) and insulinemic response at different doses and timing (before consumption of carbohydrate).
Read the detailed description
Healthy male subjects will be served with amino acid mixtures in combinations of two doses and three time points along with white rice as control. The combinations were either low or high levels of amino acid mixtures. This was consumed together or 15 min, 30 min before consumption of white rice. Postprandial blood glucose and plasma insulin concentrations were measured at fasting and every 15 min after consumption of treatment meal until 60 min after the consumption of white rice. Subsequent blood sample were taken at 30 min interval until 210min. The glucose and insulin in the blood will be analysed.
- Conditions
- Metabolic Diseases
- Being tested
- Rice and Amino Acid mixtures
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rice and Amino Acid mixturesOther
Rice and amino acid mixture
| Study group | Role | What they receive |
|---|---|---|
| White rice control | Experimental | Subjects will consume white rice as control (50g carbohydrate) Receives: Other: Rice and Amino Acid mixtures |
| co-ingest low dose of amino acid | Experimental | Subjects will receive 68 ml of amino acid mixture together with white rice Receives: Other: Rice and Amino Acid mixtures |
| co-ingest high dose of amino acid | Experimental | Subjects will receive 136 ml of amino acid mixture together with white rice Receives: Other: Rice and Amino Acid mixtures |
| pre-load low dose15 min | Experimental | Subjects will receive 68 ml of amino acid mixture 15 min before consumption of white rice Receives: Other: Rice and Amino Acid mixtures |
| pre-load low dose 30 min | Experimental | Subjects will receive 68 ml of amino acid mixture 30 min before consumption of white rice Receives: Other: Rice and Amino Acid mixtures |
| pre-load high dose 15 min | Experimental | Subjects will receive 136 ml of amino acid mixture 15 min before consumption of white rice Receives: Other: Rice and Amino Acid mixtures |
| pre-load high dose 30 min | Experimental | Subjects will receive 136 ml of amino acid mixture 30 min before consumption of white rice Receives: Other: Rice and Amino Acid mixtures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic response
Blood glucose will be assessed via finger prick during fasting and every 15 minutes for the first 60 min after the consumption white rice and subsequently every 30 min interval until 210 min
Measured: 210 minutes post consumption of carbohydrate
Insulinemic response
Plasma insulin will be assessed via finger prick during fasting and every 15 minutes for the first 60 min after the consumption white rice and subsequently every 30 min interval until 210 min
Measured: 210 minutes post consumption of carbohydrate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJun 2014
- Primary completionOct 2015
- Study completionOct 2015
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Collaborators
- Cerebos Asia Pacific Pte Ltd
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455765
- Sponsor's protocol ID
- 2014/00366
- Other IDs
- 2014
- Status last verified
- Jan 2016
- First submitted
- 21 May 2015
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Response of Co-ingesting Carbohydrate and Amino Acids
- ClinicalTrials.gov ID
- NCT02455765
- Acronym / sponsor ID
- 2014/00366
- Conditions
- Metabolic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Collaborators
- Cerebos Asia Pacific Pte Ltd
- Study start
- Jun 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 May 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.
The study will investigate if consumption of amino acid mixtures results a change in glycemic response of carbohydrate (white rice) and insulinemic response at different doses and timing (before consumption of carbohydrate).
Detailed description
Healthy male subjects will be served with amino acid mixtures in combinations of two doses and three time points along with white rice as control. The combinations were either low or high levels of amino acid mixtures. This was consumed together or 15 min, 30 min before consumption of white rice. Postprandial blood glucose and plasma insulin concentrations were measured at fasting and every 15 min after consumption of treatment meal until 60 min after the consumption of white rice. Subsequent blood sample were taken at 30 min interval until 210min. The glucose and insulin in the blood will be analysed.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| White rice control | Experimental | Other: Rice and Amino Acid mixturesSubjects will consume white rice as control (50g carbohydrate) |
| co-ingest low dose of amino acid | Experimental | Other: Rice and Amino Acid mixturesSubjects will receive 68 ml of amino acid mixture together with white rice |
| co-ingest high dose of amino acid | Experimental | Other: Rice and Amino Acid mixturesSubjects will receive 136 ml of amino acid mixture together with white rice |
| pre-load low dose15 min | Experimental | Other: Rice and Amino Acid mixturesSubjects will receive 68 ml of amino acid mixture 15 min before consumption of white rice |
| pre-load low dose 30 min | Experimental | Other: Rice and Amino Acid mixturesSubjects will receive 68 ml of amino acid mixture 30 min before consumption of white rice |
| pre-load high dose 15 min | Experimental | Other: Rice and Amino Acid mixturesSubjects will receive 136 ml of amino acid mixture 15 min before consumption of white rice |
| pre-load high dose 30 min | Experimental | Other: Rice and Amino Acid mixturesSubjects will receive 136 ml of amino acid mixture 30 min before consumption of white rice |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male
- Chinese ethnicity
- Age between 21-50 years
- Body mass index (BMI) between 18-24.9 kg/m2
- Waist circumference ≤ 90 cm for men
Key exclusion criteria (7 listed)
- dislike the consumption of Essence of Chicken
- participating in competitive sports
- allergic to amino acids and rice
- metabolic diseases (such as diabetes, hypertension and the metabolic syndromes)
- Glucose-6-Phosphate-Dehydrogenase (G6PD) Deficiency
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 |
|---|---|---|
| Rice and Amino Acid mixturesRice and amino acid mixture | Other | White rice control, co-ingest high dose of amino acid, co-ingest low dose of amino acid, pre-load high dose 15 min, pre-load high dose 30 min, pre-load low dose 30 min, pre-load low dose15 min |
Primary outcome
Glycemic response
Time frame: 210 minutes post consumption of carbohydrate
Blood glucose will be assessed via finger prick during fasting and every 15 minutes for the first 60 min after the consumption white rice and subsequently every 30 min interval until 210 min
Insulinemic response
Time frame: 210 minutes post consumption of carbohydrate
Plasma insulin will be assessed via finger prick during fasting and every 15 minutes for the first 60 min after the consumption white rice and subsequently every 30 min interval until 210 min
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 28 Jan 2016.
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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 Rice and Amino Acid mixtures 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 7 inclusion and 7 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 28 Jan 2016. 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?
Glycemic response (time frame: 210 minutes post consumption of carbohydrate). The study lists 2 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 28 Jan 2016.