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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in flow mediated dilation (FMD) of the brachial artery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women aged 18-40 years old
- •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.
- •Are able to understand the nature of the study.
- •Able to give signed written informed consent.
- •Signed informed consent form.
排除标准
- •Medical history of cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease.
- •Hypertensive, as defined as SBP superior or equal to 140 mmHg.
- •Obese participants, defined as BMI superior or equal to
- •Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies.
- •Abnormal heart rhythm (lower or higher than 60-100 bpm).
- •Allergies to dragon fruit, cactus pear or other significant food allergy.
- •Subjects under medication that can affect the cardiovascular system or on vitamin/dietary supplements.
- •Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
- •Subjects who reported participant in another study within one month before the study start.
- •Subjects who smokes.
- •Pregnant women or planning to become pregnant in the next 6 months.
- •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.
研究组 & 干预措施
Dragon fruit first then placebo
2 weeks of dragon fruit juice intake or placebo with crossover to the other
干预措施: Dragon fruit juice drink (Dietary Supplement)
Dragon fruit first then placebo
2 weeks of dragon fruit juice intake or placebo with crossover to the other
干预措施: Placebo (Dietary Supplement)
Placebo first then dragon fruit
2 weeks of dragon fruit juice intake or placebo with crossover to the other
干预措施: Dragon fruit juice drink (Dietary Supplement)
Placebo first then dragon fruit
2 weeks of dragon fruit juice intake or placebo with crossover to the other
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in flow mediated dilation (FMD) of the brachial artery
时间窗: 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.
次要结局
- Number of volunteers with treatment-related adverse events(Baseline & 12 weeks)
- Changes augmentation Index (AIx)(Baseline & 3 hour and 2 weeks post-consumption.)
- Changes in heart rate(Baseline & 2, 3 and 4 hour and 2 weeks post-consumption)
- Changes in flow mediated dilation (FMD) of the brachial artery(Baseline & 2, 3 and 4 hour post-consumption)
- Changes in blood pressure(Baseline & 2 weeks)
- Changes blood flow velocity(Baseline & 2, 3 and 4 hour and 2 weeks post-consumption)
- Changes in pulse wave velocity (PWV)(Baseline & 3 hour and 2 weeks post-consumption.)
- Changes in blood pressure(Baseline & 2, 3 and 4 hour post-consumption)
研究者
Dr Ana Rodriguez-Mateos
Lecturer in Nutritional Sciences
King's College London