Quality of Life, Sleep, Vascular Stiffness, Vasodilation
Conditions
Keywords
betalains, beetroot, vascular health, sleep, quality of life
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.
Interventions
DIETARY_SUPPLEMENTBetalains
Betalains extracted from red beetroot (Beta vulgaris) encapsulated in edible capsules. (25 mg betalains per capsule)
OTHERPlacebo
Placebo capsules containing rice hulls. (0 mg betalains per capsule)
Sponsors
VDF FutureCeuticals Inc.
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma betalains and polyphenol metabolites | Baseline, 90 minutes and 4 weeks | Measured by liquid chromotography-mass spectrometry (LC/MS) post-consumption. |
| 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. |
Countries
United Kingdom
Outcome results
None listed