Effect of Dragon Fruit Consumption in Individuals at Risk of Type 2 Diabetes
Condition: Blood Pressure; Glucose Intolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      In this project, an edible product based on dragon fruit will be tested to determine its
      effect on blood glucose levels and blood pressure in individuals at risk of type 2 diabetes.
      The effect of a product from dragon fruit on fasting plasma glucose and blood pressure will
      be assessed by a parallel study design with two groups and 16 participants in each one.
      Secondary outcomes such as inflammation biomarkers, lipid profile and oxidative stress
      markers also will be determined in blood samples.
    

Detailed description: 
      This will be a parallel study in which two different treatments will be evaluated to
      determine their effect on glucose, blood pressure, and other outcomes including dietary
      assessment in individuals at risk of diabetes. The study will last 4 weeks and will involve 3
      testing sessions. The participants (N=32) will be randomly divided into two groups and asked
      either to consume daily a dragon fruit based beverage or to follow a general health
      guidelines for 4 weeks. The treatment will be taken once a day and a 24 hours dietary recall
      will be recorded three times during the intervention; the results provided will contribute to
      understanding the role of polyphenols from the edible products based on dragon fruit on
      glucose metabolism, blood pressure and linked biomarkers.

      Treatment for testing group 1, will include an advice that involve following general health
      guidelines based on Eatwell Guide and guidelines for type 2 diabetes prevention from the
      National Institute for Health and Care Excellence (NICE) for 4 weeks. Treatment for testing
      group 2, will involve drinking a dragon fruit based beverage daily for 4 weeks.

      The first visit will start by asking participants to take part in a 24 hours dietary recall
      and by recording anthropometric measurements. Blood pressure will be taken after 10 minutes
      of rest (three measurements at five minutes intervals). Venous blood sample will be taken by
      venepunture to determine fasting blood glucose and biomarkers. Then a standard glucose drink
      (75g of glucose in 250 ml of water) will be given to determine glucose tolerance, a further
      venous sample will be taken after 2 hours. Between the 2 hours, finger-prick blood samples
      will be taken at 0, 15, 30, 45, 60, 90 and 120 minutes intervals, to evaluate the glycaemic
      and insulin response profile. The treatment will be given to the participant to start the
      intervention.

      The second session will be held 2 weeks after the treatment begins and the protocol
      established above for the first session will be followed.

      After 4 weeks of treatment the third session will be conducted, as mentioned in first and
      second sessions. Anthropometric measurements will be recorded.
    

Intervention name(s): Dragon fruit product
Intervention type(s): Other
Intervention description(s): Frozen dragon fruit based beverage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention