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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06117007
Other study ID # HeartBeet Study
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 30, 2023
Est. completion date August 15, 2024

Study information

Verified date October 2023
Source King's College London
Contact Ana Rodriguez-Mateos, PhD
Phone +44 (0)20 7848 4349
Email ana.rodriguez-mateos@kcl.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Betalains
Betalains extracted from red beetroot (Beta vulgaris) encapsulated in edible capsules. (25 mg betalains per capsule)
Other:
Placebo
Placebo capsules containing rice hulls. (0 mg betalains per capsule)

Locations

Country Name City State
United Kingdom Metabolic Research Unit (King's College London) London

Sponsors (2)

Lead Sponsor Collaborator
King's College London VDF FutureCeuticals Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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