Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05199636 |
| Other study ID # |
UREC 211527 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2022 |
| Est. completion date |
September 1, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Oxford Brookes University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
