Effects of Betalains on Cardiovascular Health and Quality of Life

NCT06117007 | Completed

• 1 other identifier: HeartBeet Study
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vascular Stiffness; Vasodilation; Sleep; Quality of Life

Keywords

betalains; beetroot; vascular health; sleep; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Changes in flow mediated dilation (FMD) of the brachial artery

  Baseline & 90 minutes

• Changes in blood pressure

  Baseline, 90 minutes and 4 weeks

• Changes in arterial stiffness

  Baseline and 4 weeks

• Changes in heart rate

  Baseline, 90 minutes and 4 weeks

• Changes in sleep quality (sleep duration, percent of light, deep and REM sleep and etc.)

  Baseline and 4 weeks

Other Outcomes (3)

• Changes in plasma erythropoietin

  Baseline, 90 minutes and 4 weeks

• Changes in red blood cell deformability

  Baseline, 90 minutes and 4 weeks

• Plasma betalains and polyphenol metabolites

  Baseline, 90 minutes and 4 weeks

Study Arms (2)

Betalains then placebo

EXPERIMENTAL

Daily consumption of 1 betalain capsule (25 mg betalains) for 28 days, then crossing over to the placebo

Dietary Supplement: Betalains; Other: Placebo

Placebo then betalains

EXPERIMENTAL

Daily consumption of 1 placebo capsule (0 mg betalains) for 28 days, then crossing over to the betalains

Dietary Supplement: Betalains; Other: Placebo

Interventions

Betalains DIETARY_SUPPLEMENT

Betalains extracted from red beetroot (Beta vulgaris) encapsulated in edible capsules. (25 mg betalains per capsule)

Betalains then placebo; Placebo then betalains

Placebo OTHER

Placebo capsules containing rice hulls. (0 mg betalains per capsule)

Betalains then placebo; Placebo then betalains

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• King's College London: lead
• VDF FutureCeuticals Inc.: collaborator

Study Sites (1)

Metabolic Research Unit (King's College London)

London, London, SE1 9NH, United Kingdom

Location

MeSH Terms

Conditions

Aneurysm

Interventions

Betalains

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Alkaloids; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ana Rodriguez-Mateos, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: November 3, 2023
• Study Start: October 30, 2023
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: November 14, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)