Liquid or Solid State of Food on Glycaemia, Lipaemia and Insulinaemia
Condition: Diabetes; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study examines the metabolic effects of 3 possible test meals (Oleogel) and/or 3
      possible test meals (Grass Jelly). The participants will have the option to voluntarily
      choose which study part(s) to participate. This study will be evaluated on 40 healthy Chinese
      male subjects from the general public over a period of one year.
    

Detailed description: 
      This study examines the metabolic effects of 3 possible test meals (Oleogel) and/or 3
      possible test meals (Grass Jelly). The participants will have the option to voluntarily
      choose which study part(s) to participate. This study will be evaluated on 40 healthy Chinese
      male subjects from the general public over a period of one year.

      Treatments will be randomized to receive 3 different test meals (Oleogel) and/or 3 different
      test meals. Randomization means assigning the participants to the test meals by chance, like
      tossing a coin or rolling a dice.

      If the participants take part in this study, the participants will be required to come on 3
      non-consecutive days and/or 5 non-consecutive days to evaluate the 3 different test meals
      (Oleogel) and/or 3 different test meal (Grass jelly) respectively, in random order with a
      minimum of 1 week between the test sessions. For each session, the participants are required
      to come between 8:00-9:00am, with each session lasting approximately 3.5 hours to 6.5 hours.
      The participants would have to come following a 10-12 hour overnight fast. An indwelling
      catheter will be inserted into a vein in the participants' forearm for the remainder of the
      test session. The investigators will then take a blood sample from the cannula to measure
      baseline values. The investigators will also take the participant's capillary blood via
      finger prick to measure blood glucose concentration. After obtaining the baseline blood
      samples, the investigator will give the participants the test meal to eat within 10 minutes
      and fill up a 'liking' questionnaire. Following the meal the investigators will take further
      blood samples (from the cannula and finger pricks) for the next 10, 20, 30, 45, 60, 90, 120,
      150, 180, (treatment 4, 5, 6), 210, 240, 270, 300, 330, 360 minutes (Treatment 1, 2, 3).

      The amount of blood that will be collected at every time point will be about 5µL droplet from
      fingerprick and approximately 5mL of blood from cannulation, the accumulative amount per test
      session will approximately 50 to 80 ml, and the accumulative amount for the entire study
      duration will be approximately 240 mL of blood by cannula and finger pricks (Part A) and 150
      ml (Part B). The investigators will also ask the participants to answer a questionnaire about
      measurement of hunger and fullness at the same times the blood samples are taken. The
      appetite-rating questionnaire consists of 100mm continuous lines anchored at each end with
      opposing statements for a question asked. The specific questions asked will be: 'How hungry
      do you feel?', 'How full do you feel?', How strong is your desire to eat?', 'How much food do
      you think you can eat?' and 'Do you have any preoccupation with thoughts of food right now?'.
      Using a pen, you would have to make a mark on the line corresponding to how you feel.

      In addition to the VAS scales, the current trial will collect information on the prospective
      portion that participants would like to consume for a range of different foods at different
      time points; at every 30 minutes interval from baseline till the end of each test session.
      This computer based task presents a range of foods to participants and asks "how much of this
      food would you like to consume right now?", allowing the participants to move between a
      series of different portions of each food and select the one that the participants would like
      to consume at that time based on the participants' feeling of hunger, fullness and desire to
      eat. The foods will be deliberately chosen to represent common Singaporean meals, desserts
      and snack foods that are regularly eaten to relieve hunger in different situations and the
      range of portions available is the same across all foods (20-1200 kcals in 20 kcal steps).

      On the evenings before the test sessions, the participants will be expected to come and
      collect a standard dinner meal. The participants will be advised not to take part in any
      strenuous physical activities for at least 3 days and avoid caffeine and alcohol consumption
      the day before the test sessions.

      Subjects participation in the study will last a maximum of 20.5 hours (Part A) and 11.5 hours
      (Part B), include one screening visit lasting around 1 hour.
    

Intervention name(s): Glucose with grass jelly solution; Glucose with grass jelly (solid); Porridge and juice with coconut oil; Porridge and juice with coconut oil gel
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 50 g glucose and 3.12 g grass jelly dissolve in water (top up to 200g); 50 g glucose and 3.12 g grass jelly and 3.12g starch dissolve in hot water (top up to 200g); Add instant porridge with hot water with oil. Consume with commercially available orange juice; Add instant porridge with hot water with oleogel. Consume with commercially available orange juice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other