The Effects of Dragon Fruit Consumption on Vascular Function.

King's College London

Status: Completed

Conditions: Healthy Men and Women

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Dragon fruit juice drink

Study type: Interventional

Funder types: Other

Identifiers

NCT03995602

DRAGON Study

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Dragon fruit first then placebo

Experimental group

Description:

2 weeks of dragon fruit juice intake or placebo with crossover to the other

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Dragon fruit juice drink

Placebo first then dragon fruit

Experimental group

Description:

2 weeks of dragon fruit juice intake or placebo with crossover to the other

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Dragon fruit juice drink