Effects of Betalains on Cardiovascular Health and Quality of Life

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Vascular Stiffness, Vasodilation, Sleep, Quality of Life

Intervention / Treatment
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* Dietary Supplement: Betalains
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Betalains<br>Daily consumption of 1 betalain capsule (25 mg betalains) for 28 days. | Dietary Supplement: Betalains<br>* Betalains extracted from red beetroot (Beta vulgaris) encapsulated in edible capsules. (25 mg betalains per capsule)<br>|
| Placebo Comparator: Placebo<br>Daily consumption of 1 placebo capsule (0 mg betalains) for 28 days. | Other: Placebo<br>* Placebo capsules containing rice hulls. (0 mg betalains per capsule)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline & 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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 | 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. | 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. | 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 | Baseline, 90 minutes and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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betalains, beetroot, vascular health, sleep, quality of life