Vascular StiffnessNCT06117007
Effects of Betalains on Cardiovascular Health and Quality of Life
A study testing Betalains in people with Vascular Stiffness and Vasodilation, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Stiffness, Vasodilation, Sleep
- What is being tested?
- Betalains
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2023to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Metabolic Research Unit (King's College London)
London, London, SE1 9NH
About this study
Official title: 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
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?
Read more
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.
- Conditions
- Vascular Stiffness, Vasodilation, Sleep, Quality of Life
- Being tested
- Betalains, Placebo
- Keywords
- betalains, beetroot, vascular health, sleep, quality of life
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetalainsDietary supplement
Betalains extracted from red beetroot (Beta vulgaris) encapsulated in edible capsules.
(25 mg betalains per capsule)
PlaceboOther
Placebo capsules containing rice hulls. (0 mg betalains per capsule)
| Study group | Role | What they receive |
|---|---|---|
| Betalains then placebo | Experimental | Daily consumption of 1 betalain capsule (25 mg betalains) for 28 days, then crossing over to the placebo Receives: Dietary Supplement: Betalains; Other: Placebo |
| Placebo then betalains | Experimental | Daily consumption of 1 placebo capsule (0 mg betalains) for 28 days, then crossing over to the betalains Receives: Dietary Supplement: Betalains; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in flow mediated dilation (FMD) of the brachial artery
Determine changes in flow-mediated dilation (FMD) of the brachial artery after 4 weeks consumption of 25 mg betalains
Measured: Baseline & 4 weeks
Secondary outcomes (7)
Changes in flow mediated dilation (FMD) of the brachial artery
Determine changes in flow-mediated dilation (FMD) of the brachial artery at 90 minutes after consumption of 25 mg betalains
Measured: Baseline & 90 minutes
Changes in blood pressure
Determine changes in systolic and diastolic blood pressure at 90 minutes and 4 weeks after consumption of 25 mg betalains
Measured: Baseline, 90 minutes and 4 weeks
Changes in arterial stiffness
Determine changes in pulse-wave velocity and pulse-wave analysis after 4 weeks of consumption of 25 mg betalains using applanation tonometry on SphygmoCor system.
Measured: Baseline and 4 weeks
Changes in heart rate
Determine changes in heart rate at 90 minutes and 4 weeks after consumption of 25 mg betalains
Measured: Baseline, 90 minutes and 4 weeks
Changes in sleep quality (sleep duration, percent of light, deep and REM sleep and etc.)
Determine changes in sleep quality (sleep duration, percent of light, deep and REM sleep etc.) after 4 weeks of consumption of 25 mg betalains using wearable activity tracker.
Measured: Baseline and 4 weeks
Changes in quality of life (quality of life scores and physical activity)
Determine changes in quality of life after 4 weeks consumption of 25 mg betalains via WHOQoL-100 questionnaire, Short Form-36 (SF-36) survey, and physical activity on wearable activity tracker.
Measured: Baseline and 4 weeks
Changes in blood flow velocity
Determine changes in blood flow velocity at 90 minutes and 4 weeks after consumption of 25 mg betalains
Measured: Baseline, 90 minutes and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start30 Oct 2023
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular StiffnessStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- VDF FutureCeuticals Inc.
- Responsible party
- Sponsor
- Investigators
- Ana Rodriguez-Mateos, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117007
- Sponsor's protocol ID
- HeartBeet Study
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06117007
- Acronym / sponsor ID
- HeartBeet Study
- Conditions
- Vascular Stiffness, Vasodilation, Sleep, Quality of Life
- Keywords
- betalains, beetroot, vascular health, sleep, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- VDF FutureCeuticals Inc.
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betalains then placebo | Experimental | Dietary Supplement: Betalains, Other: PlaceboDaily consumption of 1 betalain capsule (25 mg betalains) for 28 days, then crossing over to the placebo |
| Placebo then betalains | Experimental | Dietary Supplement: Betalains, Other: PlaceboDaily consumption of 1 placebo capsule (0 mg betalains) for 28 days, then crossing over to the betalains |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetalainsBetalains extracted from red beetroot (Beta vulgaris) encapsulated in edible capsules. (25 mg betalains per capsule) | Dietary supplement | Betalains then placebo, Placebo then betalains |
| PlaceboPlacebo capsules containing rice hulls. (0 mg betalains per capsule) | Other | Betalains then placebo, Placebo then betalains |
Primary outcome
Changes in flow mediated dilation (FMD) of the brachial artery
Time frame: Baseline & 4 weeks
Determine changes in flow-mediated dilation (FMD) of the brachial artery after 4 weeks consumption of 25 mg betalains
7 secondary outcomes
Changes in flow mediated dilation (FMD) of the brachial artery
Time frame: Baseline & 90 minutes
Changes in blood pressure
Time frame: Baseline, 90 minutes and 4 weeks
Changes in arterial stiffness
Time frame: Baseline and 4 weeks
Changes in heart rate
Time frame: Baseline, 90 minutes and 4 weeks
Changes in sleep quality (sleep duration, percent of light, deep and REM sleep and etc.)
Time frame: Baseline and 4 weeks
Changes in quality of life (quality of life scores and physical activity)
Time frame: Baseline and 4 weeks
Changes in blood flow velocity
Time frame: Baseline, 90 minutes and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Vascular Stiffness
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Rodriguez-Mateos, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betalains in people with Vascular Stiffness and Vasodilation, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in flow mediated dilation (FMD) of the brachial artery (time frame: Baseline & 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.