Diabetes Mellitus, Type 2NCT03447080
Co-ingestion of Rice Bran Soymilk or Plain Soymilk With White Bread: Effects on the Glycaemic and Insulinaemic Response
A study testing Ricebran soybean milk and Soybean milk in people with Diabetes Mellitus, Type 2, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
bread and that rice-bran soymilk will have an additional beneficial effect on the glucose and insulin The proposed research project is important because it will provide, for the first time, evidence on the benefits of the addition of rice-bran to soymilk by measuring the acute effect on the glycaemic and insulinaemic… 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, Type 2
- What is being tested?
- Ricebran soybean milk and Soybean milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Jun 2017to 18 Jan 2019
- 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
- Age between 21-60 years
- Chinese Ethnicity
- Body mass index between 18.5 - 29 kg/m2
- Fasting blood glucose < 7 mmol/L
- Normal blood pressure (<140/90 mmHg)
Who cannot join
- have metabolic diseases (such as diabetes, hypertension etc.)
- have glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Currently on prescription medication that may affect metabolism
- Intentionally restrict food intake
- Allergic to wheat bread, rice bran and soya bean
Trial locations and contacts
1 site in 1 country.
About this study
bread and that rice-bran soymilk will have an additional beneficial effect on the glucose and insulin The proposed research project is important because it will provide, for the first time, evidence on the benefits of the addition of rice-bran to soymilk by measuring the acute effect on the glycaemic and insulinaemic response in co-consumption with a high GI meal in Asians. Investigators hypothesize that soymilk will lower the glycaemic and insulinaemic response of white response. This will have an important implication for public health as investigators will understand better how additional dietary fibre can improve the local diet which is typically of high GI values. Ultimately, results from this project will enable the development of dietary recommendations for better glycaemic control in Asian people.
Read the detailed description
The study will recruit 15-20 young healthy Asian men of Chinese descent. Volunteers will visit Clinical Nutrition Research Centre (CNRC) on 5 occasions: once for consenting and screening procedures (visit 1) and four additional times, interspaced by a minimum of 2 days, to follow a 3 hour test session (Visit 2-5). The study aims to compare the effects of four different test meals , White bread, White bread , Rice-bran soymilk with white bread, Soymilk with white bread, on the glycaemic and insulinaemic response. Visit 1 (screening): For screening, potential subjects will come in the morning after an overnight fast. After obtaining informed consent, a series of screening tests will be conducted, including questionnaires (general health, physical activity and eating behaviour), anthropometry (height, weight, waist and hip circumference), blood pressure, fasting blood glucose, HbA1c and body composition by bioelectrical impedance analysis. Visits 2 to 5 (four experimental trials, in random order): Each of the four study visits will last for approximately 3 hours in the morning, during which the following will take place:During each test session, the subject arrives at the centre between 8:00 and 9:00 in the morning after an overnight fast and has been instructed to avoid any physical activity/exercise and alcohol on the day prior to the test. The session will start by placing an indwelling catheter into a vein in the forearm by trained personnel in a sterile environment. The catheter will be kept patent at all times and left on the forearm until the end of the session. Blood samples will then be taken from the cannula and from a finger prick to measure baseline levels of metabolites. Finger pricks will be done using disposable individual lancets which can cause minimal discomfort. After obtaining baseline blood samples, the subject will be given the test meal to consume within 15 minutes. Following the consumption of the test meal, blood samples (from the cannula and finger pricks) will be collected at periodic intervals (every 15 minutes for the first 90 minutes and every 30 minutes for the remaining 90 minutes). At each time point, a maximum of 5mL of blood will be drawn. In addition, at the same time points, finger prick blood samples will be taken for glucose analysis. At the end of 3 hours of testing, the catheter will be removed and the subject will be free to leave the laboratory. During the entire test session, the subject will have to stay rested and in the laboratory. Television and a workspace will be provided to the subject. In total over the 4 sessions, a maximum of 200 mL of blood (approximately 40 teaspoons) will be collected as part of this study. The blood obtained will be used to measure parameters such as glucose and insulin. Any blood obtained during the course of this study will be stored and analysed for the purposes of this study for a period not exceeding 3 years upon completion of this study. All the study diets will be prepared in the CNRC food preparation kitchen and will use locally sourced ingredients and food purchased from local supermarkets and food distributors.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Control, Ricebran soybean milk, Soybean milk
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
White Bread containing 50g carbohydrate
ControlOther
White Bread containing 50g carbohydrate
Ricebran soybean milkOther
White Bread with rice bran soybean milk
Soybean milkOther
White Bread with soybean milk
| Study group | Role | What they receive |
|---|---|---|
| Control 1 | Other | White bread Receives: Other: Control |
| Control 2 | Other | White bread Receives: Other: Control |
| Rice bran soybean milk | Experimental | White Bread with 195ml of rice bran soybean mil Receives: Other: Ricebran soybean milk |
| Soybean milk | Experimental | White Bread with 195ml of soybean milk Receives: Other: Soybean milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial blood glucose over 180 minutes period
Blood obtained through fingerprick, analysed using Hemocue analyser.
Measured: 180 minutes
Secondary outcomes (1)
Change in postprandial plasma insulin over 180 minutes period
Venous blood obtain through cannula, analysed using Cobas analyser.
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start2 Jun 2017
- Primary completion18 Jan 2019
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 study
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT03447080
- Sponsor's protocol ID
- 2017/00286
- Other IDs
- 2017
- Status last verified
- May 2019
- First submitted
- 21 Feb 2018
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-ingestion of Rice Bran Soymilk or Plain Soymilk With White Bread: Effects on the Glycaemic and Insulinaemic Response
- ClinicalTrials.gov ID
- NCT03447080
- Acronym / sponsor ID
- 2017/00286
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 27 Feb 2018 (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.
bread and that rice-bran soymilk will have an additional beneficial effect on the glucose and insulin The proposed research project is important because it will provide, for the first time, evidence on the benefits of the addition of rice-bran to soymilk by measuring the acute effect on the glycaemic and insulinaemic response in co-consumption with a high GI meal in Asians. Investigators hypothesize that soymilk will lower the glycaemic and insulinaemic response of white response. This will have an important implication for public health as investigators will understand better how additional dietary fibre can improve the local diet which is typically of high GI values. Ultimately, results from this project will enable the development of dietary recommendations for better glycaemic control in Asian people.
Detailed description
The study will recruit 15-20 young healthy Asian men of Chinese descent. Volunteers will visit Clinical Nutrition Research Centre (CNRC) on 5 occasions: once for consenting and screening procedures (visit 1) and four additional times, interspaced by a minimum of 2 days, to follow a 3 hour test session (Visit 2-5). The study aims to compare the effects of four different test meals , White bread, White bread , Rice-bran soymilk with white bread, Soymilk with white bread, on the glycaemic and insulinaemic response. Visit 1 (screening): For screening, potential subjects will come in the morning after an overnight fast. After obtaining informed consent, a series of screening tests will be conducted, including questionnaires (general health, physical activity and eating behaviour), anthropometry (height, weight, waist and hip circumference), blood pressure, fasting blood glucose, HbA1c and body composition by bioelectrical impedance analysis. Visits 2 to 5 (four experimental trials, in random order): Each of the four study visits will last for approximately 3 hours in the morning, during which the following will take place:During each test session, the subject arrives at the centre between 8:00 and 9:00 in the morning after an overnight fast and has been instructed to avoid any physical activity/exercise and alcohol on the day prior to the test. The session will start by placing an indwelling catheter into a vein in the forearm by trained personnel in a sterile environment. The catheter will be kept patent at all times and left on the forearm until the end of the session. Blood samples will then be taken from the cannula and from a finger prick to measure baseline levels of metabolites. Finger pricks will be done using disposable individual lancets which can cause minimal discomfort. After obtaining baseline blood samples, the subject will be given the test meal to consume within 15 minutes. Following the consumption of the test meal, blood samples (from the cannula and finger pricks) will be collected at periodic intervals (every 15 minutes for the first 90 minutes and every 30 minutes for the remaining 90 minutes). At each time point, a maximum of 5mL of blood will be drawn. In addition, at the same time points, finger prick blood samples will be taken for glucose analysis. At the end of 3 hours of testing, the catheter will be removed and the subject will be free to leave the laboratory. During the entire test session, the subject will have to stay rested and in the laboratory. Television and a workspace will be provided to the subject. In total over the 4 sessions, a maximum of 200 mL of blood (approximately 40 teaspoons) will be collected as part of this study. The blood obtained will be used to measure parameters such as glucose and insulin. Any blood obtained during the course of this study will be stored and analysed for the purposes of this study for a period not exceeding 3 years upon completion of this study. All the study diets will be prepared in the CNRC food preparation kitchen and will use locally sourced ingredients and food purchased from local supermarkets and food distributors.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized crossover study
| Arm | Type | Receives |
|---|---|---|
| Control 1 | Other | Other: ControlWhite bread |
| Control 2 | Other | Other: ControlWhite bread |
| Rice bran soybean milk | Experimental | Other: Ricebran soybean milkWhite Bread with 195ml of rice bran soybean mil |
| Soybean milk | Experimental | Other: Soybean milkWhite Bread with 195ml of soybean milk |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- Age between 21-60 years
- Chinese Ethnicity
- Body mass index between 18.5 - 29 kg/m2
- Fasting blood glucose < 7 mmol/L
Key exclusion criteria (5 listed)
- have metabolic diseases (such as diabetes, hypertension etc.)
- have glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Currently on prescription medication that may affect metabolism
- Intentionally restrict food intake
- Allergic to wheat bread, rice bran and soya bean
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 |
|---|---|---|
| ControlWhite Bread containing 50g carbohydrate | Other | Control 1 |
| ControlWhite Bread containing 50g carbohydrate | Other | Control 2 |
| Ricebran soybean milkWhite Bread with rice bran soybean milk | Other | Rice bran soybean milk |
| Soybean milkWhite Bread with soybean milk | Other | Soybean milk |
Primary outcome
Change in postprandial blood glucose over 180 minutes period
Time frame: 180 minutes
Blood obtained through fingerprick, analysed using Hemocue analyser.
1 secondary outcome
Change in postprandial plasma insulin over 180 minutes period
Time frame: 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 13 May 2019.
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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 Ricebran soybean milk and Soybean milk in people with Diabetes Mellitus, Type 2, 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 6 inclusion and 5 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 13 May 2019. 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?
Change in postprandial blood glucose over 180 minutes period (time frame: 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 13 May 2019.