The Effects of Dragon Fruit Consumption on Vascular Function.

June 4, 2021 updated by: Dr Ana Rodriguez-Mateos, King's College London

A Randomised, Placebo-controlled, Crossover Study of the Effects of Dragon Fruit Effects of Dragon Fruit (Pitaya) Consumption on Vascular Function in Healthy Males and Females

Native to South America and South East Asia, the dragon fruit (pitaya) has become increasingly popular world-wide due to their vivid hue and bizarre structure. More importantly, their high levels of bioactive phytochemical betalains has sparked considerable scientific interest. Recent findings from in vitro and in vivo animal studies tentatively suggest that betalains may have ameliorative effects on vascular function. This will be a first randomised controlled trial aimed to explore the impact of dragon fruit consumption on blood pressure and other vascular parameters in healthy individuals. The study will feature a randomised, double-blinded, placebo-controlled and crossover design with flow-mediated dilatation (FMD) as primary outcome along with blood pressure and arterial stiffness as secondary outcomes. Cardiovascular biomarkers as well as relevant metabolites will also be determined from blood and urine samples collected from participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, SE1 9NH
        • King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy men and women aged 18-40 years old

  2. Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body.

    weight over the duration of the study.

  3. Are able to understand the nature of the study.
  4. Able to give signed written informed consent.
  5. Signed informed consent form.

Exclusion Criteria:

  1. Medical history of cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease.
  2. Hypertensive, as defined as SBP superior or equal to 140 mmHg.
  3. Obese participants, defined as BMI superior or equal to 30.
  4. Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies.
  5. Abnormal heart rhythm (lower or higher than 60-100 bpm).
  6. Allergies to dragon fruit, cactus pear or other significant food allergy.
  7. Subjects under medication that can affect the cardiovascular system or on vitamin/dietary supplements.
  8. Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
  9. Subjects who reported participant in another study within one month before the study start.
  10. Subjects who smokes.
  11. Pregnant women or planning to become pregnant in the next 6 months.
  12. Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dragon fruit first then placebo
2 weeks of dragon fruit juice intake or placebo with crossover to the other
Dietary supplement: Dragon fruit juice drink
Dragon fruit drink containing 24 g of freeze-dried dragon fruit powder dissolved in low nitrate water.
Dietary supplement: Placebo
Drink with macro- and micro-nutrient matched against the intervention drink.
Experimental: Placebo first then dragon fruit
2 weeks of dragon fruit juice intake or placebo with crossover to the other
Dietary supplement: Dragon fruit juice drink
Dragon fruit drink containing 24 g of freeze-dried dragon fruit powder dissolved in low nitrate water.
Dietary supplement: Placebo
Drink with macro- and micro-nutrient matched against the intervention drink.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in flow mediated dilation (FMD) of the brachial artery
Time Frame: Baseline & 2 weeks
Determine changes in flow mediated dilation (FMD) of the brachial artery after 2 weeks consumption of 24 g freeze-dried dragon fruit.
Baseline & 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in flow mediated dilation (FMD) of the brachial artery
Time Frame: Baseline & 2, 3 and 4 hour post-consumption
Determine changes in flow mediated dilation (FMD) of the brachial artery at 2, 3, and 4 hour post consumption of 24 g freeze-dried dragon fruit.
Baseline & 2, 3 and 4 hour post-consumption
Changes in blood pressure
Time Frame: Baseline & 2, 3 and 4 hour post-consumption
Determine changes in systolic and diastolic blood pressure at 2, 3, and 4 hour post consumption of 24 g freeze-dried dragon fruit.
Baseline & 2, 3 and 4 hour post-consumption
Changes in blood pressure
Time Frame: Baseline & 2 weeks
Determine changes in systolic and diastolic blood pressure after 2 weeks post consumption of 24 g freeze-dried dragon fruit.
Baseline & 2 weeks
Changes in heart rate
Time Frame: Baseline & 2, 3 and 4 hour and 2 weeks post-consumption
Determine changes in heart rate post consumption of 24 g freeze-dried dragon fruit.
Baseline & 2, 3 and 4 hour and 2 weeks post-consumption
Changes blood flow velocity
Time Frame: Baseline & 2, 3 and 4 hour and 2 weeks post-consumption
Determine changes in blood flow velocity post consumption of 24 g freeze-dried dragon fruit.
Baseline & 2, 3 and 4 hour and 2 weeks post-consumption
Changes in pulse wave velocity (PWV)
Time Frame: Baseline & 3 hour and 2 weeks post-consumption.
Determine changes in pulse wave velocity post consumption of 24 g freeze-dried dragon fruit.
Baseline & 3 hour and 2 weeks post-consumption.
Changes augmentation Index (AIx)
Time Frame: Baseline & 3 hour and 2 weeks post-consumption.
Determine changes in augmentation index post consumption of 24 g freeze-dried dragon fruit.
Baseline & 3 hour and 2 weeks post-consumption.
Number of volunteers with treatment-related adverse events
Time Frame: Baseline & 12 weeks
The number of volunteers with treatment-related adverse events will be assessed by questionnaires and interviews.
Baseline & 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma and urine betalains and (poly)phenol metabolites
Time Frame: Baseline and 3 hours and 2 weeks post consumption
Measured by liquid chromotography- mass spectrometry (LC/MS) post consumption.
Baseline and 3 hours and 2 weeks post consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2019

Primary Completion (Actual)

January 22, 2020

Study Completion (Actual)

January 22, 2020

Study Registration Dates

First Submitted

June 20, 2019

First Submitted That Met QC Criteria

June 21, 2019

First Posted (Actual)

June 24, 2019

Study Record Updates

Last Update Posted (Actual)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DRAGON Study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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