Effects of Betalains on Cardiovascular Health and Quality of Life (NCT06117007) | Clinical Trial Compass
CompletedNot Applicable
Effects of Betalains on Cardiovascular Health and Quality of Life
United Kingdom42 participantsStarted 2023-10-30
Plain-language summary
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.
Who can participate
Age range
40 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in flow mediated dilation (FMD) of the brachial artery