Clinical trial NCT05199636: Effect of Dragon Fruit Consumption in Individuals at Risk of Type 2 Diabetes
Official title: Effect of Dragon Fruit Consumption on Glycaemic Response and Blood Pressure in Individuals at Risk of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Glucose Intolerance
Lead sponsor: Oxford Brookes University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Aged 18-50 years who fulfil at least two of the following inclusion criteria:

  * Have a first grade relative with diabetes (parent, brother, or sister)
  * Have a BMI ≥ 25.0.
  * Have a sedentary lifestyle.

Exclusion Criteria:

* • Covid-19 related symptoms, during the last 7 days.

  * Allergies to dragon fruit.
  * Diabetes, hypertension, or renal disease.
  * Medication that requires prescription.
  * Pregnant or breastfeeding.

Primary outcomes:
measure: Blood glucose response
timeFrame: 2 hours
measure: Blood pressure
timeFrame: 15 minutes
Secondary outcomes:
measure: Plasma insulin response
timeFrame: 2 hours
measure: C-reactive protein
timeFrame: 5 minutes
measure: HbA1C
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Brookes Centre for Nutrition and Health
Study officials:
affiliation: Oxford Brookes University
name: Sangeetha Thondre, PhD
role: PRINCIPAL_INVESTIGATOR
References: