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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Singapore1 site
  • Clinical Nutrition Reseach Centre

    Singapore, 117599

Other trials in Singapore

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.

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 groups in NCT03447080
Study groupRoleWhat they receive
Control 1OtherWhite bread
Receives: Other: Control
Control 2OtherWhite bread
Receives: Other: Control
Rice bran soybean milkExperimentalWhite Bread with 195ml of rice bran soybean mil
Receives: Other: Ricebran soybean milk
Soybean milkExperimentalWhite 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.

  1. Change in postprandial blood glucose over 180 minutes period

    Blood obtained through fingerprick, analysed using Hemocue analyser.

    Measured: 180 minutes

Secondary outcomes (1)
  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.

  1. First posted27 Feb 2018
  2. Study start2 Jun 2017
  3. Primary completion18 Jan 2019
  4. Study completion18 Jan 2019

Resources

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)
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

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.

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