Diabetes MellitusNCT04228341
The Effect of Degree of Rice-polishing on Glycaemic Response
A study testing Glucose Reference 1, Glucose Reference 2 and Glucose Reference 3 in people with Diabetes Mellitus and Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
To investigate the effects of rice polishing on glycaemic and insulinaemic response in healthy Chinese male volunteers. Read more about this study
- Who is it for?
- Ages 21 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Obesity
- What is being tested?
- Glucose Reference 1, Glucose Reference 2 and Glucose Reference 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Feb 2019to 18 Jun 2020
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Chinese ethnicity
- Age ≥21 and ≤ 60 years
- Body mass index between 18.5 to 25 kg/m2
- Normal blood pressure =<140/90 mmHg
- Fasting blood glucose <6.0 mmol/L
- In general good health
Who cannot join
- Current smoker
- Have any metabolic diseases (such as diabetes, hypertension etc)
- Do not have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
- Have intolerances or allergies to any foods
- Currently partake in sports at the competitive and/or endurance levels
- Intentionally restrict food intake
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effects of rice polishing on glycaemic and insulinaemic response in healthy Chinese male volunteers.
Read the detailed description
There will be a total of 8 test session. Each session will last for 3.5 hours. At each test session, volunteers will be served with test meal and blood will be collected. After an overnight fast, subjects will visit the research center. Two fasting capillary blood samples will be collected via fingerprick. Following the fasting samples, subject will consume the test meals. Further blood samples will be collected at 15, 30, 45, 60, 90, 120, 150, 180 minutes after the ingestion of test meal. These samples will be used to analyses for whole capillary blood glucose. At every 30 minute interval, samples will be collected for analysis of capillary plasma insulin.
- Conditions
- Diabetes Mellitus, Obesity
- Being tested
- Glucose Reference 1, Glucose Reference 2, Glucose Reference 3, Brown Rice, 3 % polished rice
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose Reference 1Other
50 g of glucose dissolved in 250 ml of water (First glucose control visit)
Glucose Reference 2Other
50 g of glucose dissolved in 250 ml of water (Second glucose control visit)
Glucose Reference 3Other
50 g of glucose dissolved in 250 ml of water (Third glucose control visit)
Brown RiceOther
Unpolished brown rice containing 50 g of available carbohydrate was cooked using a rice cooker (Toyomi) at a ratio of rice to water of 1: 2
3 % polished riceOther
3% polished rice, containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2
6 % polished riceOther
6% polished rice, containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2
9 % polished riceOther
9 % polished rice, containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2
20 % Polished riceOther
White rice (20% polished rice), containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2.
| Study group | Role | What they receive |
|---|---|---|
| Glucose Reference 1 | Other | Glucose solution 1 Receives: Other: Glucose Reference 1 |
| Glucose Reference 2 | Other | Glucose solution 2 Receives: Other: Glucose Reference 2 |
| Glucose Reference 3 | Other | Glucose solution 3 Receives: Other: Glucose Reference 3 |
| Brown Rice | Experimental | Cooked brown rice Receives: Other: Brown Rice |
| 3 % polished rice | Experimental | Cooked 3 % polished rice Receives: Other: 3 % polished rice |
| 6 % polished rice | Experimental | Cooked 6 % polished rice Receives: Other: 6 % polished rice |
| 9 % polished rice | Experimental | 9 % polished rice Receives: Other: 9 % polished rice |
| 20 % Polished rice | Experimental | Cooked 20 % Polished rice (White Rice) Receives: Other: 20 % Polished rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Whole capillary blood glucose will be measure using Hemocue analyser
Measured: Up to 180 minutes
Secondary outcomes (1)
Insulin
Capillary plasma will be measure using Cobas analyser
Measured: Up to 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start13 Feb 2019
- Primary completion26 Jul 2019
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Model description
- Randomized crossover design
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228341
- Sponsor's protocol ID
- 2018/01079
- Other IDs
- 2018
- Status last verified
- Aug 2021
- First submitted
- 11 Jan 2020
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Degree of Rice-polishing on Glycaemic Response
- ClinicalTrials.gov ID
- NCT04228341
- Acronym / sponsor ID
- 2018/01079
- Conditions
- Diabetes Mellitus, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 26 Jul 2019 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 14 Jan 2020 (actual)
- 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.
To investigate the effects of rice polishing on glycaemic and insulinaemic response in healthy Chinese male volunteers.
Detailed description
There will be a total of 8 test session. Each session will last for 3.5 hours. At each test session, volunteers will be served with test meal and blood will be collected. After an overnight fast, subjects will visit the research center. Two fasting capillary blood samples will be collected via fingerprick. Following the fasting samples, subject will consume the test meals. Further blood samples will be collected at 15, 30, 45, 60, 90, 120, 150, 180 minutes after the ingestion of test meal. These samples will be used to analyses for whole capillary blood glucose. At every 30 minute interval, samples will be collected for analysis of capillary plasma insulin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Randomized crossover design
| Arm | Type | Receives |
|---|---|---|
| Glucose Reference 1 | Other | Other: Glucose Reference 1Glucose solution 1 |
| Glucose Reference 2 | Other | Other: Glucose Reference 2Glucose solution 2 |
| Glucose Reference 3 | Other | Other: Glucose Reference 3Glucose solution 3 |
| Brown Rice | Experimental | Other: Brown RiceCooked brown rice |
| 3 % polished rice | Experimental | Other: 3 % polished riceCooked 3 % polished rice |
| 6 % polished rice | Experimental | Other: 6 % polished riceCooked 6 % polished rice |
| 9 % polished rice | Experimental | Other: 9 % polished rice9 % polished rice |
| 20 % Polished rice | Experimental | Other: 20 % Polished riceCooked 20 % Polished rice (White Rice) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male
- Chinese ethnicity
- Age ≥21 and ≤ 60 years
- Body mass index between 18.5 to 25 kg/m2
- Normal blood pressure =<140/90 mmHg
Key exclusion criteria (7 listed)
- Current smoker
- Have any metabolic diseases (such as diabetes, hypertension etc)
- Do not have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
- Have intolerances or allergies to any foods
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 |
|---|---|---|
| Glucose Reference 150 g of glucose dissolved in 250 ml of water (First glucose control visit) | Other | Glucose Reference 1 |
| Glucose Reference 250 g of glucose dissolved in 250 ml of water (Second glucose control visit) | Other | Glucose Reference 2 |
| Glucose Reference 350 g of glucose dissolved in 250 ml of water (Third glucose control visit) | Other | Glucose Reference 3 |
| Brown RiceUnpolished brown rice containing 50 g of available carbohydrate was cooked using a rice cooker (Toyomi) at a ratio of rice to water of 1: 2 | Other | Brown Rice |
| 3 % polished rice3% polished rice, containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2 | Other | 3 % polished rice |
| 6 % polished rice6% polished rice, containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2 | Other | 6 % polished rice |
| 9 % polished rice9 % polished rice, containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2 | Other | 9 % polished rice |
| 20 % Polished riceWhite rice (20% polished rice), containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2. | Other | 20 % Polished rice |
Primary outcome
Glucose
Time frame: Up to 180 minutes
Whole capillary blood glucose will be measure using Hemocue analyser
1 secondary outcome
Insulin
Time frame: Up to 180 minutes
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 20 Aug 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose Reference 1, Glucose Reference 2 and Glucose Reference 3 in people with Diabetes Mellitus and Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
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 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Glucose (time frame: Up to 180 minutes). 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 20 Aug 2021.