Effects of Betalains on Cardiovascular Health and Quality of Life
Study Details
Study Description
Brief 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:
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Do betalains improve vascular function?
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Do betalains improve sleep?
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Do betalains improve quality of life?
Participants will be involved with the following:
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Consuming a daily betalain-rich or placebo capsule for a month
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Non-invasive cardiovascular measurements
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Wearing a fitness tracker for tracking physical activity and sleep
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Betalains Daily consumption of 1 betalain capsule (25 mg betalains) for 28 days. |
Dietary Supplement: Betalains
Betalains extracted from red beetroot (Beta vulgaris) encapsulated in edible capsules.
(25 mg betalains per capsule)
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| Placebo Comparator: Placebo Daily consumption of 1 placebo capsule (0 mg betalains) for 28 days. |
Other: Placebo
Placebo capsules containing rice hulls. (0 mg betalains per capsule)
|
Outcome Measures
Primary Outcome Measures
- Changes in flow mediated dilation (FMD) of the brachial artery [Baseline & 4 weeks]
Determine changes in flow-mediated dilation (FMD) of the brachial artery after 4 weeks consumption of 25 mg betalains
Secondary Outcome Measures
- Changes in flow mediated dilation (FMD) of the brachial artery [Baseline & 90 minutes]
Determine changes in flow-mediated dilation (FMD) of the brachial artery at 90 minutes after consumption of 25 mg betalains
- Changes in blood pressure [Baseline, 90 minutes and 4 weeks]
Determine changes in systolic and diastolic blood pressure at 90 minutes and 4 weeks after consumption of 25 mg betalains
- Changes in arterial stiffness [Baseline and 4 weeks]
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.
- Changes in heart rate [Baseline, 90 minutes and 4 weeks]
Determine changes in heart rate at 90 minutes and 4 weeks after consumption of 25 mg betalains
- Changes in sleep quality (sleep duration, percent of light, deep and REM sleep and etc.) [Baseline and 4 weeks]
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.
- Changes in quality of life (quality of life scores and physical activity) [Baseline and 4 weeks]
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.
- Changes in blood flow velocity [Baseline, 90 minutes and 4 weeks]
Determine changes in blood flow velocity at 90 minutes and 4 weeks after consumption of 25 mg betalains
Other Outcome Measures
- Changes in plasma erythropoietin [Baseline, 90 minutes and 4 weeks]
Determine changes in plasma erythropoietin at 90 minutes and 4 weeks after consumption of 25 mg betalains
- Changes in red blood cell deformability [Baseline, 90 minutes and 4 weeks]
Determine changes in red blood cell deformability at 90 minutes and 4 weeks after consumption of 25 mg betalains measured via osmotic gradient ektacytometry.
- Plasma betalains and polyphenol metabolites [Baseline, 90 minutes and 4 weeks]
Measured by liquid chromotography-mass spectrometry (LC/MS) post-consumption.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged between 40 and 65 years
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BMI between 25-29.9 kg/m2
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Own a smartphone.
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Able to understand the nature of the study and give informed consent
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Have not gained or lost more than 10% of body weight (within the past 3 months)
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Not currently involved or have participated in another biomedical study (within the last 3 months)
Exclusion Criteria:
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Smoking or vaping (within the last 2 years)
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Vegetarian or vegan (due to capsule material)
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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]
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Grade II hypertension (blood pressure: >160/100 mmHg)
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Under medication that can affect the cardiovascular system (within the last 2 months)
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Taking supplements (except vitamin D and iron) (within the last month)
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Intolerances or allergies toward beetroots, dragon fruit or rice hulls
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History of excess alcohol intake or substance abuse.
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Pregnant or planning to become pregnant in the next 6 months
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Under hormonal replacement therapy (contraceptives are allowed)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Metabolic Research Unit (King's College London) | London | United Kingdom | SE1 9NH |
Sponsors and Collaborators
- King's College London
- VDF FutureCeuticals Inc.
Investigators
- Principal Investigator: Ana Rodriguez-Mateos, PhD, King's College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HeartBeet Study