Effects of Betalains on Cardiovascular Health and Quality of Life

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117007
• Other study ID #: HeartBeet Study
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Quality of Life
• Sleep
• Vascular Stiffness
• Vasodilation

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