An interventional study of Dragon fruit product in Blood Pressure and Glucose Intolerance, sponsored by Oxford Brookes University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by Oxford Brookes University · Not applicable, Interventional, and Prevention
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.
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.
778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 645 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →Oxford Brookes University is the lead sponsor of 32 studies on the registry; 5 are open to participants now.
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Aged 18-50 years who fulfil at least two of the following inclusion criteria:
Exclusion Criteria:
Covid-19 related symptoms, during the last 7 days.
A dragon fruit beverage
Other: Dragon fruit product
Based on Eatwell guide and guidelines for type 2 diabetes prevention from the National Institute for Health and Care Excellence (NICE)
Frozen dragon fruit based beverage
Blood glucose response
Blood glucose in venous blood sample
Time frame: 2 hours
Blood pressure
Systolic and diastolic blood pressure
Time frame: 15 minutes
Plasma insulin response
Insulin response in fingerprick blood sample
Time frame: 2 hours
C-reactive protein
C-reactive protein
Time frame: 5 minutes
HbA1C
Glycated hemoglobin
Time frame: 5 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Oxford Brookes University