The Effects of Dragon Fruit Consumption on Vascular Function.

Healthy Men and Women Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995602
• Other study ID #: DRAGON Study
• Status: Completed
• Phase: N/A
• Start date: June 18, 2019
• Est. completion date: January 22, 2020

Study information

• Verified date: June 2021
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 22, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Men and Women

Intervention

Dietary Supplement:
• Dragon fruit juice drink
Dragon fruit drink containing 24 g of freeze-dried dragon fruit powder dissolved in low nitrate water.
• Placebo
Drink with macro- and micro-nutrient matched against the intervention drink.

Locations

Country	Name	City	State
United Kingdom	King's College London	London	England

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma and urine betalains and (poly)phenol metabolites	Measured by liquid chromotography- mass spectrometry (LC/MS) post consumption.	Baseline and 3 hours and 2 weeks post consumption
Primary	Changes in flow mediated dilation (FMD) of the brachial artery	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	Changes in flow mediated dilation (FMD) of the brachial artery	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
Secondary	Changes in blood pressure	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
Secondary	Changes in blood pressure	Determine changes in systolic and diastolic blood pressure after 2 weeks post consumption of 24 g freeze-dried dragon fruit.	Baseline & 2 weeks
Secondary	Changes in heart rate	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
Secondary	Changes blood flow velocity	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
Secondary	Changes in pulse wave velocity (PWV)	Determine changes in pulse wave velocity post consumption of 24 g freeze-dried dragon fruit.	Baseline & 3 hour and 2 weeks post-consumption.
Secondary	Changes augmentation Index (AIx)	Determine changes in augmentation index post consumption of 24 g freeze-dried dragon fruit.	Baseline & 3 hour and 2 weeks post-consumption.
Secondary	Number of volunteers with treatment-related adverse events	The number of volunteers with treatment-related adverse events will be assessed by questionnaires and interviews.	Baseline & 12 weeks