King's College London
London, England, SE1 9NH, United Kingdom
NCT Number: NCT03995602
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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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
London, England, SE1 9NH, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
weight over the duration of the study.
Exclusion criteria
Dragon fruit drink containing 24 g of freeze-dried dragon fruit powder dissolved in low nitrate water.
Drink with macro- and micro-nutrient matched against the intervention drink.
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.
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.
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.
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.
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.
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.
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.
Time frame: Baseline & 3 hour and 2 weeks post-consumption.
Determine changes in augmentation index post consumption of 24 g freeze-dried dragon fruit.
Time frame: Baseline & 12 weeks
The number of volunteers with treatment-related adverse events will be assessed by questionnaires and interviews.
Time frame: Baseline and 3 hours and 2 weeks post consumption
Measured by liquid chromotography- mass spectrometry (LC/MS) post consumption.
King's College London
Other
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
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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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