The Dose Effects of Isomaltulose and Sucrose on Glycaemic and Insulinemic Response
Condition: Type 2 Diabetes; Obesity; Pre Diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State
Study type: Interventional

Summary: 
      This study will determine the glycaemic and insulinaemic response and sensory profile of the
      drinks with various ratios sucrose:isomaltulose. The information will be useful for
      manufacturers of beverages to produce blood glucose friendlier drinks. The information will
      also be useful for dieticians and clinicians in recommending foods and drinks for people with
      diabetes. The information will also be useful to the public for making better food choices.
      The data will also provide insights on how the different ratios of sweeteners may affect
      glycaemic and insulinaemic indices (GI and II).
    

Detailed description: 
      The aim of the study is to determine the optimal mixture of sucrose with isomaltulose that
      will produce optimal reduction in glycaemia and an acceptable sensory profile. These will be
      assessed among three different ethnicities.The study will recruit a maximum of 60 healthy
      young (21-60 years old) males from three ethnicities (Malay, Indian, and Chinese). Each
      participant will take part in 9 separate test sessions on nonconsecutive days, and consume 3
      reference control drinks and 6 different test drinks. On each of the test days, participants
      will consume either the reference drink (50g of anhydrous glucose dissolved in 300 ml of
      water) or one of the test drinks which consists of 50g of sucrose and/or isomaltulose
      dissolved in 300 ml of water in the following ratios: 0:100, 100:0, 50:50, 80:20, 70:30,
      60:40 sucrose:isomaltulose. Study population: The study will recruit a maximum of 65 healthy
      young (21-60 years old) males. At least 10 participants will be selected from the three
      ethnicities (Malay, Indian, and Chinese). Males will be selected in order to avoid effects of
      the menstrual cycle. Participants will be recruited from the general public in Singapore and
      will be between 21 and 60 years, with a body mass index between 22 and 27 kg/m2.Design: The
      experimental protocol adopted is a pre-validated method used repeatedly for measuring the GI
      of foods. The testing follows a randomised, single-blinded, between-subjects, crossover
      design with participants returning on 9 non-consecutive days. Reference food testing
      (standard glucose solution) will precede test food testing. On each test day, participant
      will consume either the reference drink or one of the test drinks. The test sessions will be
      made up of 3 identical reference drinks and 6 test drinks. The number sessions each
      participant will complete will be determined by the researcher and communicated to the
      participant. For the 9 test sessions, participants arrive at the laboratory between 8:30-9 am
      following a 10 hour overnight fast. They are instructed not to partake in intense level
      sports and avoid alcohol consumption on the evening prior to a test session. Following a 10
      minute rest two blood samples are obtained five minutes apart for determining baseline blood
      glucose levels. They are then given either the standard or test drink to consume. They are
      instructed to consume the food at a comfortable pace within 12 minutes. After consumption of
      the test drink, subjects will complete a liking questionnaire. Further blood samples are
      obtained at 15, 30, 45, 60, 90, 120, 150 and 180 minutes for blood glucose measurements and
      insulin (at every half hour intervals).Reference/Test foods: The reference drink will be
      anhydrous glucose (50 g) (standard) dissolved in 300 ml of water) and will be consumed on 3
      occasions. The test drinks will consist of 50g of sucrose and/or isomaltulose dissolved in
      300 ml of water in the following ratios: 0:100, 100:0, 50:50, 80:20, 70:30, 60:40
      sucrose:isomaltulose. A total of 6 test drinks will be tested. The participant will be
      requested to finish both reference and test drink within 12min.Blood collection: Participants
      will be asked to attend the testing sessions after an overnight fast of ten to twelve hours.
      Two fasting blood samples will be collected by finger prick for glucose measurement and not
      more than 0.5ml finger prick blood sample will also be collected to measure baseline insulin.
      A drop of blood will be collected into a HemoCue® cuvette (Helsingborg, Sweden) for blood
      glucose analysis. In addition, not more than 0.5ml of finger prick blood will be collected
      for the analyses of plasma insulin concentrations. Participants will then consume the test
      meal within 12 minutes. Following this, approximately 5µl of blood samples will be collected
      at 15, 30, 45, 60, 90, 120, 150 and 180min for glucose measurements and not more than 0.5ml
      of blood samples will be collected at 30, 60, 90, 120, 150 and 180min for insulin
      measurements.'Liking' questionnaire: On the testing session days, participants will be asked
      to rate their 'liking' for the test meal. Participants will be rate their 'overall liking'
      for the test meal on a 100 mm Visual Analog Scale anchored with 'dislike extremely' (0 mm),
      'neither like nor dislike' (50 mm) and 'like extremely' (100 mm) immediately after they
      consume the test meal.Screening: Potential participants will first attend a screening session
      for consenting and eligibility procedures. Participants will arrive in the morning following
      an overnight fast. During the screening, a questionnaire will have to be completed and
      anthropometry and blood pressure will be assessed. Screening questionnaire: The screening
      questionnaire will include contact information, demographic, general health details, and
      physical activity level. This information will be used to determine whether the participant
      is eligible for the study, as well as to check for any possible confounders that may
      influence the study outcomes. Anthropometric measurements: Body weight and body composition
      will be measured using bioelectrical impedance analysis. Height will be measured using a
      stadiometer in order to calculate participants' BMI. Waist circumference will be measured at
      the minimum circumference between the iliac crest and the rib cage. Hip circumference will be
      measured at the maximum protuberance of the buttocks. Blood pressure will also be measured.
      Blood pressure: Blood pressure will be measured using an Omron blood pressure monitor (Model
      HEM-907) at baseline. Participants will be seated for five minutes before blood pressure is
      measured. Measurements will be taken in duplicate and the averaged results will be recorded.
    

Intervention name(s): Glucose Solution 1; Glucose Solution 2; Glucose Solution 3; Sucrose/Isomaltulose 100:0; Sucrose/Isomaltulose 0:100; Sucrose/Isomaltulose 50:50; Sucrose/Isomaltulose 60:40; Sucrose/Isomaltulose 70:30; Sucrose/Isomaltulose 80:20
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): 50g glucose dissolve in 300ml of water; 50g glucose dissolve in 300ml of water; 50g glucose dissolve in 300ml of water; 50g sucrose dissolve in 300ml of water; 50g isomaltulose dissolve in 300ml of water; 25g sucrose and 25g isomaltulose dissolve in 300ml of water; 30g sucrose and 20g isomaltulose dissolve in 300ml of water; 35g sucrose and 15g isomaltulose dissolve in 300ml of water; 40g sucrose and 10g isomaltulose dissolve in 300ml of water
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized crossover study
Masking: None (Open Label)
Primary purpose: Other