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OpenTrials
Completed

NCT Number: NCT06117007

Effects of Betalains on Cardiovascular Health and Quality of Life

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.

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Key information

Conditions

Vascular Stiffness Aneurysm Cardiovascular Diseases Quality of Life Sleep Vascular Diseases Vasodilation

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metabolic Research Unit (King's College London)

London, SE1 9NH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Betalains

Dietary Supplement

Betalains extracted from red beetroot (Beta vulgaris) encapsulated in edible capsules.

(25 mg betalains per capsule)

Placebo

Other

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

Primary outcomes

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

    Time frame: Baseline & 4 weeks

    Determine changes in flow-mediated dilation (FMD) of the brachial artery after 4 weeks consumption of 25 mg betalains

Secondary outcomes

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

    Time frame: Baseline & 90 minutes

    Determine changes in flow-mediated dilation (FMD) of the brachial artery at 90 minutes after consumption of 25 mg betalains

  2. Changes in blood pressure

    Time frame: Baseline, 90 minutes and 4 weeks

    Determine changes in systolic and diastolic blood pressure at 90 minutes and 4 weeks after consumption of 25 mg betalains

  3. Changes in arterial stiffness

    Time frame: Baseline and 4 weeks

    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.

  4. Changes in heart rate

    Time frame: Baseline, 90 minutes and 4 weeks

    Determine changes in heart rate at 90 minutes and 4 weeks after consumption of 25 mg betalains

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

    Time frame: Baseline and 4 weeks

    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.

  6. Changes in quality of life (quality of life scores and physical activity)

    Time frame: Baseline and 4 weeks

    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.

  7. Changes in blood flow velocity

    Time frame: Baseline, 90 minutes and 4 weeks

    Determine changes in blood flow velocity at 90 minutes and 4 weeks after consumption of 25 mg betalains

Other outcomes

  1. Changes in plasma erythropoietin

    Time frame: Baseline, 90 minutes and 4 weeks

    Determine changes in plasma erythropoietin at 90 minutes and 4 weeks after consumption of 25 mg betalains

  2. Changes in red blood cell deformability

    Time frame: Baseline, 90 minutes and 4 weeks

    Determine changes in red blood cell deformability at 90 minutes and 4 weeks after consumption of 25 mg betalains measured via osmotic gradient ektacytometry.

  3. Plasma betalains and polyphenol metabolites

    Time frame: Baseline, 90 minutes and 4 weeks

    Measured by liquid chromotography-mass spectrometry (LC/MS) post-consumption.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • VDF FutureCeuticals Inc.

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 3, 2023
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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