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:
-
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.
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)
|
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:
-
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)
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