Investigating the effects of beetroot-derived betalains on heart health and quality of life
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
This study is testing if taking beetroot capsules can improve heart health, sleep quality, and overall well-being in healthy middle-aged people.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06117007 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled, cross-over trial aims to explore the impact of betalains, derived from beetroot, on cardiovascular health, sleep quality, and overall quality of life in healthy middle-aged individuals. Participants will consume either a betalain-rich capsule or a placebo daily for one month, while their cardiovascular function will be assessed through non-invasive measurements. Additionally, they will track their physical activity and sleep using fitness trackers and complete questionnaires regarding their quality of life. The study will compare outcomes between the two groups to determine any significant differences.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 40 to 65 years with a BMI between 25-29.9 kg/m2.
Not a fit: Patients with chronic diseases or those on medications affecting cardiovascular health may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new dietary recommendations for improving cardiovascular health and enhancing quality of life.
How similar studies have performed: While the specific effects of betalains on cardiovascular health are less explored, similar studies on dietary interventions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
London
- Metabolic Research Unit (King's College London) — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Ana Rodriguez-Mateos, PhD — King's College London
- Study coordinator: Ana Rodriguez-Mateos, PhD
- Email: ana.rodriguez-mateos@kcl.ac.uk
- Phone: +44 (0)20 7848 4349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.