Oxford Brookes Centre for Nutrition and Health
Oxford, United Kingdom
NCT Number: NCT05199636
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.
Looking for future studies?
Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Oxford, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Frozen dragon fruit based beverage
Time frame: 2 hours
Blood glucose in venous blood sample
Time frame: 15 minutes
Systolic and diastolic blood pressure
Time frame: 2 hours
Insulin response in fingerprick blood sample
Time frame: 5 minutes
C-reactive protein
Time frame: 5 minutes
Glycated hemoglobin
Oxford Brookes University
Other
Effect of Dragon Fruit Consumption on Glycaemic Response and Blood Pressure in Individuals at Risk of Type 2 Diabetes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03938389
Blood Pressure, Body Weight
Columbus, Ohio, United States
View Trial DetailsNCT04817137
Blood Pressure
Boston, Massachusetts, United States
View Trial DetailsNCT07713576
Blood Pressure
Chenzhou, Hunan, China
View Trial DetailsNCT06550297
Blood Pressure, Cardiovascular Diseases
New York, United States
View Trial Details