Co-ingestion of Rice Bran Soymilk or Plain Soymilk With White Bread: Effects on the Glycaemic and Insulinaemic Response
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Control
Control
Ricebran soybean milk
Soybean milk
Sponsored by

About this trial
This is an interventional other trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Clinical Nutrition Reseach Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Experimental
Experimental
Arm Label
Control 1
Control 2
Rice bran soybean milk
Soybean milk
Arm Description
White bread
White bread
White Bread with 195ml of rice bran soybean mil
White Bread with 195ml of soybean milk
Outcomes
Primary Outcome Measures
Change in postprandial blood glucose over 180 minutes period
Blood obtained through fingerprick, analysed using Hemocue analyser.
Secondary Outcome Measures
Change in postprandial plasma insulin over 180 minutes period
Venous blood obtain through cannula, analysed using Cobas analyser.
Full Information
NCT ID
NCT03447080
First Posted
February 21, 2018
Last Updated
May 10, 2019
Sponsor
Clinical Nutrition Research Centre, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03447080
Brief Title
Co-ingestion of Rice Bran Soymilk or Plain Soymilk With White Bread: Effects on the Glycaemic and Insulinaemic Response
Official Title
Co-ingestion of Rice Bran Soymilk or Plain Soymilk With White Bread: Effects on the Glycaemic and Insulinaemic Response
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
January 18, 2019 (Actual)
Study Completion Date
January 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Nutrition Research Centre, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized crossover study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control 1
Arm Type
Other
Arm Description
White bread
Arm Title
Control 2
Arm Type
Other
Arm Description
White bread
Arm Title
Rice bran soybean milk
Arm Type
Experimental
Arm Description
White Bread with 195ml of rice bran soybean mil
Arm Title
Soybean milk
Arm Type
Experimental
Arm Description
White Bread with 195ml of soybean milk
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
White Bread containing 50g carbohydrate
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
White Bread containing 50g carbohydrate
Intervention Type
Other
Intervention Name(s)
Ricebran soybean milk
Intervention Description
White Bread with rice bran soybean milk
Intervention Type
Other
Intervention Name(s)
Soybean milk
Intervention Description
White Bread with soybean milk
Primary Outcome Measure Information:
Title
Change in postprandial blood glucose over 180 minutes period
Description
Blood obtained through fingerprick, analysed using Hemocue analyser.
Time Frame
180 minutes
Secondary Outcome Measure Information:
Title
Change in postprandial plasma insulin over 180 minutes period
Description
Venous blood obtain through cannula, analysed using Cobas analyser.
Time Frame
180 minutes
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
All healthy male subjects
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Facility Information:
Facility Name
Clinical Nutrition Reseach Centre
City
Singapore
ZIP/Postal Code
117599
Country
Singapore
12. IPD Sharing Statement
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Co-ingestion of Rice Bran Soymilk or Plain Soymilk With White Bread: Effects on the Glycaemic and Insulinaemic Response
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