The Effects of Dragon Fruit Consumption on Vascular Function.

Not Applicable

Completed

• Conditions: Healthy Men and Women
• Interventions: Dietary Supplement: Dragon fruit juice drink; Dietary Supplement: Placebo

• Registration Number: NCT03995602
• Lead Sponsor: King's College London

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 available

Study Timeline

• Study Start: 2019-06-18
• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-24
• Primary Completion: 2020-01-22
• Study Completion: 2020-01-22
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-04
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo first then dragon fruit	Placebo	2 weeks of dragon fruit juice intake or placebo with crossover to the other
Dragon fruit first then placebo	Dragon fruit juice drink	2 weeks of dragon fruit juice intake or placebo with crossover to the other
Dragon fruit first then placebo	Placebo	2 weeks of dragon fruit juice intake or placebo with crossover to the other
Placebo first then dragon fruit	Dragon fruit juice drink	2 weeks of dragon fruit juice intake or placebo with crossover to the other

Primary Outcome Measures

Name	Time	Method
Changes in flow mediated dilation (FMD) of the brachial artery	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

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

Trial Locations

Locations (1)

King's College London; 🇬🇧 London, England, United Kingdom