Clinical trial NCT06117007: Effects of Betalains on Cardiovascular Health and Quality of Life
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vascular Stiffness
Vasodilation
Sleep
Quality of Life
Keywords: betalains
beetroot
vascular health
sleep
quality of life
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: VDF FutureCeuticals Inc.
First posted: 2023-11-03
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Changes in flow mediated dilation (FMD) of the brachial artery
timeFrame: Baseline & 4 weeks
Secondary outcomes:
measure: Changes in flow mediated dilation (FMD) of the brachial artery
timeFrame: Baseline & 90 minutes
measure: Changes in blood pressure
timeFrame: Baseline, 90 minutes and 4 weeks
measure: Changes in arterial stiffness
timeFrame: Baseline and 4 weeks
measure: Changes in heart rate
timeFrame: Baseline, 90 minutes and 4 weeks
measure: Changes in sleep quality (sleep duration, percent of light, deep and REM sleep and etc.)
timeFrame: Baseline and 4 weeks
measure: Changes in quality of life (quality of life scores and physical activity)
timeFrame: Baseline and 4 weeks
measure: Changes in blood flow velocity
timeFrame: Baseline, 90 minutes and 4 weeks
Other outcomes:
measure: Changes in plasma erythropoietin
timeFrame: Baseline, 90 minutes and 4 weeks
measure: Changes in red blood cell deformability
timeFrame: Baseline, 90 minutes and 4 weeks
measure: Plasma betalains and polyphenol metabolites
timeFrame: Baseline, 90 minutes and 4 weeks
Locations:
city: London
country: United Kingdom
facility: Metabolic Research Unit (King's College London)
Study officials:
affiliation: King's College London
name: Ana Rodriguez-Mateos, PhD
role: PRINCIPAL_INVESTIGATOR
References: