NCT06117007

Effects of Betalains on Cardiovascular Health and Quality of Life

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vascular Stiffness
• Vasodilation
• Sleep
• Quality of Life

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Betalains	Betalains extracted from red beetroot (Beta vulgaris) encapsulated in edible capsules. (25 mg betalains per capsule)
OTHER	Placebo	Placebo capsules containing rice hulls. (0 mg betalains per capsule)

Timeline

• Start date: 2023-10-30
• Primary completion: 2024-12-19
• Completion: 2024-12-19
• First posted: 2023-11-03
• Last updated: 2025-11-14

Locations

1 site across 1 country: United Kingdom