Blood PressureNCT05199636
Effect of Dragon Fruit Consumption in Individuals at Risk of Type 2 Diabetes
A study testing Dragon fruit product in people with Blood Pressure and Glucose Intolerance, run by Oxford Brookes University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Glucose Intolerance
- What is being tested?
- Dragon fruit product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jan 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Brookes Centre for Nutrition and Health
Oxford
About this study
Official title: Effect of Dragon Fruit Consumption on Glycaemic Response and Blood Pressure in Individuals at Risk of Type 2 Diabetes
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.
Read the 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.
- Conditions
- Blood Pressure, Glucose Intolerance
- Being tested
- Dragon fruit product
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dragon fruit productOther
Frozen dragon fruit based beverage
| Study group | Role | What they receive |
|---|---|---|
| Dragon fruit product | Experimental | A dragon fruit beverage Receives: Other: Dragon fruit product |
| General health advice | No intervention | Based on Eatwell guide and guidelines for type 2 diabetes prevention from the National Institute for Health and Care Excellence (NICE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose response
Blood glucose in venous blood sample
Measured: 2 hours
Blood pressure
Systolic and diastolic blood pressure
Measured: 15 minutes
Secondary outcomes (3)
Plasma insulin response
Insulin response in fingerprick blood sample
Measured: 2 hours
C-reactive protein
C-reactive protein
Measured: 5 minutes
HbA1C
Glycated hemoglobin
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start20 Jan 2022
- Primary completion31 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sangeetha Thondre, Oxford Brookes University
- Investigators
- Sangeetha Thondre, PhD, Principal investigator, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199636
- Sponsor's protocol ID
- UREC 211527
- Status last verified
- Sep 2023
- First submitted
- 6 Jan 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flores-Verastegui MIM, Coe S, Tammam J, Almahjoubi H, Bridle R, Bi S, Thondre PS. Effects of Frozen Red Dragon Fruit Consumption on Metabolic Markers in Healthy Subjects and Individuals at Risk of Type 2 Diabetes. Nutrients. 2025 Jan 25;17(3):441. doi: 10.3390/nu17030441.
PubMed 39940297
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dragon Fruit Consumption on Glycaemic Response and Blood Pressure in Individuals at Risk of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05199636
- Acronym / sponsor ID
- UREC 211527
- Conditions
- Blood Pressure, Glucose Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dragon fruit product | Experimental | Other: Dragon fruit productA dragon fruit beverage |
| General health advice | No intervention | –Based on Eatwell guide and guidelines for type 2 diabetes prevention from the National Institute for Health and Care Excellence (NICE) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-50 years who fulfil at least two of the following inclusion criteria:
Key exclusion criteria (5 listed)
- • Covid-19 related symptoms, during the last 7 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dragon fruit productFrozen dragon fruit based beverage | Other | Dragon fruit product |
Primary outcome
Blood glucose response
Time frame: 2 hours
Blood glucose in venous blood sample
Blood pressure
Time frame: 15 minutes
Systolic and diastolic blood pressure
3 secondary outcomes
Plasma insulin response
Time frame: 2 hours
C-reactive protein
Time frame: 5 minutes
HbA1C
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 39940297Flores-Verastegui MIM, Coe S, Tammam J, Almahjoubi H, Bridle R, Bi S, Thondre PS. Effects of Frozen Red Dragon Fruit Consumption on Metabolic Markers in Healthy Subjects and Individuals at Risk of Type 2 Diabetes. Nutrients. 2025 Jan 25;17(3):441. doi: 10.3390/nu17030441.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangeetha Thondre, PhD principal investigator
Oxford Brookes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dragon fruit product in people with Blood Pressure and Glucose Intolerance, run by Oxford Brookes University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose response (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05199636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.