Effect of Dragon Fruit Consumption in Individuals at Risk of Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Glucose Intolerance; Blood Pressure
• Intervention / Treatment: Other: Dragon fruit product

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom
    • Oxford Brookes Centre for Nutrition and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dragon fruit product; A dragon fruit beverage	Other: Dragon fruit product; Frozen dragon fruit based beverage
No Intervention: General health advice; Based on Eatwell guide and guidelines for type 2 diabetes prevention from the National Institute for Health and Care Excellence (NICE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose response	Blood glucose in venous blood sample	2 hours
Blood pressure	Systolic and diastolic blood pressure	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma insulin response	Insulin response in fingerprick blood sample	2 hours
C-reactive protein	C-reactive protein	5 minutes
HbA1C	Glycated hemoglobin	5 minutes

Collaborators and Investigators

• Sponsor: Oxford Brookes University
• Investigators: Principal Investigator: Sangeetha Thondre, PhD, Oxford Brookes University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: UREC 211527

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No