Effects of Betalains on Cardiovascular Health and Quality of Life
NCT ID: NCT06117007
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
42 participants
INTERVENTIONAL
2023-10-30
2024-12-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Betalains then placebo
Daily consumption of 1 betalain capsule (25 mg betalains) for 28 days, then crossing over to the placebo
Betalains
Betalains extracted from red beetroot (Beta vulgaris) encapsulated in edible capsules.
(25 mg betalains per capsule)
Placebo
Placebo capsules containing rice hulls. (0 mg betalains per capsule)
Placebo then betalains
Daily consumption of 1 placebo capsule (0 mg betalains) for 28 days, then crossing over to the betalains
Betalains
Betalains extracted from red beetroot (Beta vulgaris) encapsulated in edible capsules.
(25 mg betalains per capsule)
Placebo
Placebo capsules containing rice hulls. (0 mg betalains per capsule)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Betalains
Betalains extracted from red beetroot (Beta vulgaris) encapsulated in edible capsules.
(25 mg betalains per capsule)
Placebo
Placebo capsules containing rice hulls. (0 mg betalains per capsule)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
40 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
VDF FutureCeuticals Inc.
INDUSTRY
King's College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ana Rodriguez-Mateos, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Metabolic Research Unit (King's College London)
London, London, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HeartBeet Study
Identifier Type: -
Identifier Source: org_study_id