Co-ingestion of Rice Bran Soymilk or Plain Soymilk With White Bread: Effects on the Glycaemic and Insulinaemic Response
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): Control; Control; Ricebran soybean milk; Soybean milk
Intervention type(s): Other; Other; Other; Other
Intervention description(s): White Bread containing 50g carbohydrate; White Bread containing 50g carbohydrate; White Bread with rice bran soybean milk; White Bread with soybean milk
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized crossover study
Masking: None (Open Label)
Primary purpose: Other