A Randomised, Placebo-controlled, Crossover Study of the Effects of a Betalain-rich Extract on Vascular Function, Sleep and Quality of Life in Middle-Aged Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 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
The goal of this randomized, double-blind, placebo-controlled, cross-over trial is to investigate the effects of beetroot-derived betalains on cardiovascular health, sleep and quality of life in healthy middle-aged individuals. The main question[s] it aims to answer are:
- Do betalains improve vascular function?
- Do betalains improve sleep?
- Do betalains improve quality of life?
Participants will be involved with the following:
- Consuming a daily betalain-rich or placebo capsule for a month
- Non-invasive cardiovascular measurements
- Wearing a fitness tracker for tracking physical activity and sleep
- Answering questionnaires regarding quality of life
Researchers will compare results between the intervention versus the placebo group to see if any of the study outcomes are significantly different.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 40 and 65 years
- •BMI between 25-29.9 kg/m2
- •Own a smartphone.
- •Able to understand the nature of the study and give informed consent
- •Have not gained or lost more than 10% of body weight (within the past 3 months)
- •Not currently involved or have participated in another biomedical study (within the last 3 months)
排除标准
- •Smoking or vaping (within the last 2 years)
- •Vegetarian or vegan (due to capsule material)
- •Medical history of chronic disease [coronary artery disease, previous myocardial infarction (heart attack), stroke, peripheral artery disease, diabetes mellitus, chronic kidney disease, metabolic syndrome, malignancies, etc]
- •Grade II hypertension (blood pressure: >160/100 mmHg)
- •Under medication that can affect the cardiovascular system (within the last 2 months)
- •Taking supplements (except vitamin D and iron) (within the last month)
- •Intolerances or allergies toward beetroots, dragon fruit or rice hulls
- •History of excess alcohol intake or substance abuse.
- •Pregnant or planning to become pregnant in the next 6 months
- •Under hormonal replacement therapy (contraceptives are allowed)
研究组 & 干预措施
Betalains then placebo
Daily consumption of 1 betalain capsule (25 mg betalains) for 28 days, then crossing over to the placebo
干预措施: Betalains (Dietary Supplement)
Betalains then placebo
Daily consumption of 1 betalain capsule (25 mg betalains) for 28 days, then crossing over to the placebo
干预措施: Placebo (Other)
Placebo then betalains
Daily consumption of 1 placebo capsule (0 mg betalains) for 28 days, then crossing over to the betalains
干预措施: Betalains (Dietary Supplement)
Placebo then betalains
Daily consumption of 1 placebo capsule (0 mg betalains) for 28 days, then crossing over to the betalains
干预措施: Placebo (Other)
结局指标
主要结局
Changes in flow mediated dilation (FMD) of the brachial artery
时间窗: Baseline & 4 weeks
Determine changes in flow-mediated dilation (FMD) of the brachial artery after 4 weeks consumption of 25 mg betalains
次要结局
- Changes in quality of life (quality of life scores and physical activity)(Baseline and 4 weeks)
- Changes in flow mediated dilation (FMD) of the brachial artery(Baseline & 90 minutes)
- Changes in blood pressure(Baseline, 90 minutes and 4 weeks)
- Changes in heart rate(Baseline, 90 minutes and 4 weeks)
- Changes in arterial stiffness(Baseline and 4 weeks)
- Changes in sleep quality (sleep duration, percent of light, deep and REM sleep and etc.)(Baseline and 4 weeks)
- Changes in blood flow velocity(Baseline, 90 minutes and 4 weeks)