Effects of Betalains on Cardiovascular Health and Quality of Life

Phase

N/A

Condition

Aneurysm

Low Blood Pressure (Hypotension)

Treatment

Placebo

Betalains

Clinical Study ID

NCT06117007

HeartBeet Study

Ages 40-65
All Genders
Accepts Healthy Volunteers

Study 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

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 thelast 3 months)

Exclusion

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 myocardialinfarction (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 2months)
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 Design