Effect of Dragon Fruit Consumption in Individuals at Risk of Type 2 Diabetes
Primary Purpose
Blood Pressure, Glucose Intolerance
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dragon fruit product
Sponsored by
About this trial
This is an interventional prevention trial for Blood Pressure
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.
Sites / Locations
- Oxford Brookes Centre for Nutrition and Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dragon fruit product
General health advice
Arm Description
A dragon fruit beverage
Based on Eatwell guide and guidelines for type 2 diabetes prevention from the National Institute for Health and Care Excellence (NICE)
Outcomes
Primary Outcome Measures
Blood glucose response
Blood glucose in venous blood sample
Blood pressure
Systolic and diastolic blood pressure
Secondary Outcome Measures
Plasma insulin response
Insulin response in fingerprick blood sample
C-reactive protein
C-reactive protein
HbA1C
Glycated hemoglobin
Full Information
NCT ID
NCT05199636
First Posted
January 6, 2022
Last Updated
September 4, 2023
Sponsor
Oxford Brookes University
1. Study Identification
Unique Protocol Identification Number
NCT05199636
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford Brookes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Glucose Intolerance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dragon fruit product
Arm Type
Experimental
Arm Description
A dragon fruit beverage
Arm Title
General health advice
Arm Type
No Intervention
Arm Description
Based on Eatwell guide and guidelines for type 2 diabetes prevention from the National Institute for Health and Care Excellence (NICE)
Intervention Type
Other
Intervention Name(s)
Dragon fruit product
Intervention Description
Frozen dragon fruit based beverage
Primary Outcome Measure Information:
Title
Blood glucose response
Description
Blood glucose in venous blood sample
Time Frame
2 hours
Title
Blood pressure
Description
Systolic and diastolic blood pressure
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Plasma insulin response
Description
Insulin response in fingerprick blood sample
Time Frame
2 hours
Title
C-reactive protein
Description
C-reactive protein
Time Frame
5 minutes
Title
HbA1C
Description
Glycated hemoglobin
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangeetha Thondre, PhD
Organizational Affiliation
Oxford Brookes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford Brookes Centre for Nutrition and Health
City
Oxford
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Dragon Fruit Consumption in Individuals at Risk of Type 2 Diabetes
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