Metabolic Response Evaluation of Low-sugar Snack Bars
Condition: Pre Diabetes; Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Prediabetic State
Study type: Interventional

Summary: 
      To determine the post-prandial metabolic response and biomarker response, following the
      consumption of newly developed low glycaemic index (GI) snack bars. The snack bars are
      formulated with different combinations and ratios of ingredients and food structures. The low
      sugar products maintaining glucose homeostasis and preventing metabolic problems may have
      commercial potential as a novel functional ingredient in a variety of fields, including
      nutrition, medicine, and agriculture.
    

Detailed description: 
      In this study we will study and compare the postprandial metabolic response of 5 snack bar
      variants, 1 control product and 2 glucose (25g) reference drinks. The study will have a total
      of 8 test sessions in a non-blinded, crossover design. Online computer software will be used
      for simple randomization of the sequence of the 8 treatments (http://www.randomizer.org/).The
      5 snack bars variants will be similar in macronutrient composition but will differ in the
      source of carbohydrate, fibre and protein (rice, bamboo, inulin, soy, promitor). They will be
      compared to a visually similar control product (crokao) that is higher in sugar. The
      reference drink will be anhydrous glucose (25g) dissolved in 250 ml of water.Study
      population: 15-20 participants will be recruited from each of the following ethnicities:
      Chinese, Indian and Caucasian. During the screening session, participants will receive an
      informed consent form and given ample time to go through it and rectify any queries they have
      with the researcher. The number of test sessions will be discussed between the researcher and
      the participants, depending on the volunteer's schedule. If they decide to take part in the
      study, they will be asked to sign the informed consent form. They will then be asked to
      complete a screening questionnaire and subsequently baseline measurements including
      anthropometric measurements, blood pressure, and fasting blood glucose will be collected from
      each participant in order to determine their eligibility. The screening questionnaire will
      include 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 (Tanita scale). 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 and hip circumference will be measured at the maximum
      protuberance of the buttocks. 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.

      Study protocol: The day before a test day, participants will be encouraged to consume their
      usual diet and avoid alcohol consumption and participating in vigorous exercise. On test
      days, participants will arrive at the laboratory after an overnight fast of 10 h. Upon
      arrival, participants will be asked to void, and have their weight and body fat assessed with
      a Tanita scale. After that, participants will enter the clinical suit and rest for 15 min
      before a blood catheter is inserted in the antecubital vein of the arm. After the blood
      catheter is inserted, participants will rest for 15 min, before two baseline blood sample (6
      mL) are taken 10 minutes apart (-10 min and 0 min). Immediately after the second sample,
      participants will be served a test food that has to be consumed within 15 min. Subsequently
      blood samples (6mL) are obtained at 15, 30, 45, 60, 90,120, 180 and 240min. Appetite
      sensations (e.g. hunger, fullness, desire-to-eat etc.) will also be measured using
      questionnaires at similar time points when blood samples are taken. Subjects will be asked to
      rate their appetite sensations on a 100 mm visual analogue scale (VAS). After each session,
      the blood catheter will be removed. The participants will leave the laboratory and they will
      be asked to keep a food diary of what they eat for the remaining day. Participants will
      return until all test foods are consumed. 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.Blood samples will be will analysed for METABOLIC RESPONSE (glucose, insulin,
      Triglycerides, NEFA, GLP-1 and ghrelin). A 100 uL aliquot of blood during the first blood
      sample collection (T = -10min) will be obtained from each participant on the first day of
      treatment (thus only once) for baseline metabolomics profiling.A stool sample from each
      participant will be obtained to perform the following on the microbiome: DNA extraction,
      library prep, 16S and shotgun (whole genome) sequencing, and demultiplexing of genomic data.
      The stool sample will be collected between the screening session and the last test session
      (time of collection will not influence the sample analysis). The participant will be
      encouraged to collect the stool sample during one of the sessions at the research centre to
      eliminate transport of the sample.
    

Intervention name(s): Control 1; Control 2; Standard Crokao; Low sugar variant 1; Low sugar variant 2; Low sugar variant 3; Low sugar variant 4; Low sugar variant 5
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): 25g glucose dissolve in 250ml of water; 25g glucose dissolve in 250ml of water; Standard Crokao containing 25g of available carbohydrate; Low sugar variant 1 containing 25g of available carbohydrate; Low sugar variant 2 containing 25g of available carbohydrate; Low sugar variant 3 containing 25g of available carbohydrate; Low sugar variant 4 containing 25g of available carbohydrate; Low sugar variant 5 containing 25g of available carbohydrate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized crossover study
Masking: Single (Participant)
Primary purpose: Other