Quality of Life Clinical Trial
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? 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.
Status | Recruiting |
Enrollment | 42 |
Est. completion date | August 15, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 65 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Metabolic Research Unit (King's College London) | London |
Lead Sponsor | Collaborator |
---|---|
King's College London | VDF FutureCeuticals Inc. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in plasma erythropoietin | Determine changes in plasma erythropoietin at 90 minutes and 4 weeks after consumption of 25 mg betalains | Baseline, 90 minutes and 4 weeks | |
Other | Changes in red blood cell deformability | Determine changes in red blood cell deformability at 90 minutes and 4 weeks after consumption of 25 mg betalains measured via osmotic gradient ektacytometry. | Baseline, 90 minutes and 4 weeks | |
Other | Plasma betalains and polyphenol metabolites | Measured by liquid chromotography-mass spectrometry (LC/MS) post-consumption. | Baseline, 90 minutes and 4 weeks | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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