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Effects of Betalains on Cardiovascular Health and Quality of Life

Recruiting
40 - 65 years of age
Both
Phase N/A

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Overview

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

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)

Study details

Vascular Stiffness, Vasodilation, Sleep, Quality of Life

NCT06117007

King's College London

26 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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