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Completed

NCT Number: NCT03995602

The Effects of Dragon Fruit Consumption on Vascular Function.

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College London

London, England, SE1 9NH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

  • Medical history of cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease.
  • Hypertensive, as defined as SBP superior or equal to 140 mmHg.
  • Obese participants, defined as BMI superior or equal to 30.
  • Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies.
  • Abnormal heart rhythm (lower or higher than 60-100 bpm).
  • Allergies to dragon fruit, cactus pear or other significant food allergy.
  • Subjects under medication that can affect the cardiovascular system or on vitamin/dietary supplements.
  • Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
  • Subjects who reported participant in another study within one month before the study start.
  • Subjects who smokes.
  • Pregnant women or planning to become pregnant in the next 6 months.
  • 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.

Treatment and study plan

Dragon fruit juice drink

Dietary Supplement

Dragon fruit drink containing 24 g of freeze-dried dragon fruit powder dissolved in low nitrate water.

Placebo

Dietary Supplement

Drink with macro- and micro-nutrient matched against the intervention drink.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2019
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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