Effects of Betalains on Cardiovascular Health and Quality of Life

Not Applicable

Recruiting

• Conditions: Vasodilation; Quality of Life; Vascular Stiffness; Sleep
• Interventions: Other: Placebo; Dietary Supplement: Betalains

• Registration Number: NCT06117007
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-11
• Study Start: 2023-10-30
• Study First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Study First Posted: 2023-11-03
• Last Update Posted: 2023-11-03
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Daily consumption of 1 placebo capsule (0 mg betalains) for 28 days.
Betalains	Betalains	Daily consumption of 1 betalain capsule (25 mg betalains) for 28 days.

Primary Outcome Measures

Name	Time	Method
Changes in flow mediated dilation (FMD) of the brachial artery	Baseline & 4 weeks	Determine changes in flow-mediated dilation (FMD) of the brachial artery after 4 weeks consumption of 25 mg betalains

Secondary Outcome Measures

Name	Time	Method
Changes in flow mediated dilation (FMD) of the brachial artery	Baseline & 90 minutes	Determine changes in flow-mediated dilation (FMD) of the brachial artery at 90 minutes after consumption of 25 mg betalains
Changes in blood pressure	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
Changes in heart rate	Baseline, 90 minutes and 4 weeks	Determine changes in heart rate at 90 minutes and 4 weeks after consumption of 25 mg betalains
Changes in quality of life (quality of life scores and physical activity)	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.
Changes in arterial stiffness	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.
Changes in sleep quality (sleep duration, percent of light, deep and REM sleep and etc.)	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.
Changes in blood flow velocity	Baseline, 90 minutes and 4 weeks	Determine changes in blood flow velocity at 90 minutes and 4 weeks after consumption of 25 mg betalains

Trial Locations

Locations (1)

Metabolic Research Unit (King's College London); 🇬🇧 London, United Kingdom