Screening of Phytochemical Rich Ingredients as 'Functional Foods' to Improve Cardiometabolic Health
Condition: Metabolic Disease
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      To find out whether consumption of different kinds of plant based functional food
      ingredients, traditionally used in Asia, can improve post-meal response of indicators of
      heart and metabolic (cardiometabolic) function.
    

Detailed description: 
      The study will be a non-blinded, randomised crossover trial with each participants testing
      between 2 to 4 different test ingredients requiring 5 or 9 separate test sessions (depending
      on how many the participants opt in for) on 9 non-consecutive days. The number of test
      ingredients that each participant will consume will be determined by the researcher and
      communicated to the participant. One of the test sessions will be a control session
      consisting of plain white rice (50 g available carbohydrates), with 20 g green vegetables
      being consumed with 200 ml of plain water. On the other hand, the test meal ingredients will
      be added either to the same amount of rice during preparation or will be added to 200 ml of
      plain water. The participants will be required to finish the meals within 15 minutes of
      serving. Appropriate food safety guidelines will be adhered to during the preparation and
      administration of test meals. We will be testing 20 separate food based traditional
      ingredients at either one or two doses. 20 participants will be recruited for each test food.
      Assuming that a minimum 2 test ingredients are tested in each participant up to 200 Chinese
      male participants aged between 21 and 60 years will be recruited from the general public in
      Singapore with body mass index between18.5 to 25.0 kg/m2, normal blood pressure (<140/90
      mmHg), and fasting blood glucose (<7.0 mmol/L). The exclusion criteria are people who smoke,
      with any metabolic diseases (such as diabetes, hypertension etc), with glucose-6-phosphate
      dehydrogenase deficiency (G6PD deficiency), with medical conditions and/ or taking
      medications known to affect glycemia (glucocorticoids, thyroid hormones, thiazide diuretics),
      intolerances or allergies to any foods, partake in sports at the competitive and/or endurance
      levels and individual who intentionally restrict food intake. Interested participants will
      first attend a consent and screening visit following an overnight fast to go over the
      informed consent procedure and ascertain their suitability to take part in the study. During
      this visit, the researchers will discuss the study in more detail and go through the
      participant information sheet and address any queries that the potential participant may
      have. If participants are willing to proceed, they will then be asked to sign the informed
      consent form and complete the screening visit forms and questionnaires. If suitable to
      proceed, they will then undertake the screening visit measurements including height, weight,
      waist circumference, body impedance and blood pressure measurements. If suitable at this
      stage, a finger prick blood glucose measurement will be carried out using the HemoCue® device
      (Helsingborg, Sweden). The visit should last approximately 1.5 hours. During each of the test
      days, participants will receive test meals in a random order made with up to 4 different food
      based test ingredients or the control meal (without any test ingredients). Randomisation of
      test meals will be done using the =RAND() function in Excel. The ingredients will tested in
      various doses and/or forms of consumption. The participants will arrive at the study centre
      following an overnight fast. After a 15 minute rest period, they will have a cannula inserted
      in their arm to obtain blood samples at regular intervals. There will be 9 blood draws in
      total per test session: Baseline (0 h, before test meal) and 8 blood samples after test meals
      at 0.25 h, 0.5 h, 0.75 h, 1.0 h, 1.5 h, 2.0 h, 2.5 h and 3.0 h. At each time point, we will
      collect 3 ml (about half a teaspoon) of blood. Therefore, for each test day, up to 30 ml
      blood will be taken and for the entire 9 test sessions, around 270 ml of blood will be
      collected (around 18 tablespoons) or if the participants only opt in for 5 test sessions,
      they will donate approximately 150 ml of blood (around 10 tablespoons). The blood samples
      collected at each timepoint will be measured for glucose, insulin and markers related to the
      intake of the test meal ingredients. At 4 time points (0 h, 1 h, 2 h and 3 h), seated blood
      pressure measurements will also be undertaken for 3 times, using an automated
      sphygmomanometer (Omron, Japan) and the average of the final two blood pressure readings will
      be taken as that given timepoint. Each test day should take no longer than 4 hours to
      complete. Participants will be asked to refrain from alcohol and exercise the day before each
      test day. The study will last between 4 and 12 weeks to compete and each test session will be
      undertaken on non- consecutive days, dependent on the participants' availability. The
      participants will be asked to continue with their usual lifestyle during their study
      participation when they are not attending the test sessions.
    

Intervention name(s): Control; Cumin Rice; Cumin Drink; Cornsilk Rice (Low dose); Cornsilk Rice (High dose); Cornsilk Drink (Low dose); Cornsilk Drink (High dose); Tamarind Rice; Tamarind Drink
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Plain rice with plain water; Cumin rice with plain water; Cumin drink with plain rice; Low dose cornsilk rice with plain water; High dose cornsilk rice with plain water; Low dose cornsilk drink with plain rice; High dose cornsilk drink with plain rice; Tamarind rice with plain water; Tamarind drink with plain rice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other