Effects of Betalains on Cardiovascular Health and Quality of Life

King's College London

Status: Enrolling

Conditions: Quality of Life; Vasodilation; Vascular Stiffness; Sleep

Treatments: Dietary Supplement: Betalains; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06117007

HeartBeet Study

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

Betalains

Active Comparator group

Description:

Daily consumption of 1 betalain capsule (25 mg betalains) for 28 days.

Treatment:

Dietary Supplement: Betalains

Placebo

Placebo Comparator group

Description:

Daily consumption of 1 placebo capsule (0 mg betalains) for 28 days.

Treatment:

Other: Placebo