Effects of Betalains on Cardiovascular Health and Quality of Life

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Sleep; Vascular Stiffness; Vasodilation
• Intervention / Treatment: Dietary supplement: Betalains; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London
    • London, London, United Kingdom, SE1 9NH
      • Metabolic Research Unit (King's College London)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Betalains then placebo; Daily consumption of 1 betalain capsule (25 mg betalains) for 28 days, then crossing over to the placebo	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)
Experimental: Placebo then betalains; Daily consumption of 1 placebo capsule (0 mg betalains) for 28 days, then crossing over to the betalains	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)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Plasma betalains and polyphenol metabolites	Measured by liquid chromotography-mass spectrometry (LC/MS) post-consumption.	Baseline, 90 minutes and 4 weeks

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: VDF FutureCeuticals Inc.
• Investigators: Principal Investigator: Ana Rodriguez-Mateos, PhD, King's College London

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Actual): December 19, 2024
• Study Completion (Actual): December 19, 2024

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: sleep; quality of life; beetroot; vascular health; betalains
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aneurysm; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Alkaloids; Amines; Piperidines; Amino Acids; Quaternary Ammonium Compounds; Onium Compounds; Amino Acids, Aromatic; Amino Acids, Cyclic; Tyrosine; Betalains
• Other Study ID Numbers: HeartBeet Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No