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出境医 / 临床实验 / The Effects of Dragon Fruit Consumption on Vascular Function.

The Effects of Dragon Fruit Consumption on Vascular Function.

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Men and Women Dietary Supplement: Dragon fruit juice drink Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : June 18, 2019
Actual Primary Completion Date : January 22, 2020
Actual Study Completion Date : January 22, 2020
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Locations
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United Kingdom
King's College London
London, England, United Kingdom, SE1 9NH
Sponsors and Collaborators
King's College London
Investigators
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Principal Investigator: Ana Rodriguez-Mateos, PhD King's College London
Tracking Information
First Submitted Date  ICMJE June 20, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date June 7, 2021
Actual Study Start Date  ICMJE June 18, 2019
Actual Primary Completion Date January 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 21, 2019) 		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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effects of Dragon Fruit Consumption on Vascular Function.
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Men and Women
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Dragon fruit first then placebo
    2 weeks of dragon fruit juice intake or placebo with crossover to the other
    Interventions:
    • Dietary Supplement: Dragon fruit juice drink
    • Dietary Supplement: Placebo
  • Experimental: Placebo first then dragon fruit
    2 weeks of dragon fruit juice intake or placebo with crossover to the other
    Interventions:
    • Dietary Supplement: Dragon fruit juice drink
    • Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 22, 2020
Actual Primary Completion Date January 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995602
Other Study ID Numbers  ICMJE DRAGON Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr Ana Rodriguez-Mateos, King's College London
Study Sponsor  ICMJE King's College London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ana Rodriguez-Mateos, PhD King's College London
PRS Account King's College London
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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