NCT05199636

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

1.6 years

First QC Date

January 6, 2022

Last Update Submit

September 4, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Blood glucose response

    Blood glucose in venous blood sample

    2 hours

  • Blood pressure

    Systolic and diastolic blood pressure

    15 minutes

Secondary Outcomes (3)

  • Plasma insulin response

    2 hours

  • C-reactive protein

    5 minutes

  • HbA1C

    5 minutes

Study Arms (2)

Dragon fruit product

EXPERIMENTAL

A dragon fruit beverage

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)

Interventions

Frozen dragon fruit based beverage

Dragon fruit product

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Brookes Centre for Nutrition and Health

Oxford, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sangeetha Thondre, PhD

    Oxford Brookes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

January 6, 2022

First Posted

January 20, 2022

Study Start

January 20, 2022

Primary Completion

August 31, 2023

Study Completion

September 1, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations