Effects of the Combination of Beetroot and Pomegranate Extracts on Flow-Mediated Dilation and Fatigue in Adult Humans: A Randomized, Double-Blind, Placebo- Controlled, Dose-Ranging, Cross-Over Study

Introduction: Dietary supplements rich in nitrates and ellagic acid such as beetroot and pomegranate extracts respectively can enhance cardiorespiratory endurance and help in sustained performance, efficient recovery, reduced fatigue, increased metabolic efficiency, preventing injury, and improved health.In this study, a combination of hydro-alcoholic extracts of beetroot and pomegranate peel extract (BPE) is investigated for its effects on flow-mediated dilation in the brachial artery and fatigue reduction.Methods: This was a prospective, randomized (1:1:1=BPE 500mg: BPE 1000mg: Placebo), double-blind, placebo-controlled, three-treatment, three-period, dose-ranging, crossover clinical interventional study involving a population of 21 healthy individuals aged 20 to 35 years.The primary endpoint assessed the mean Flow-Mediated Dilation (FMD); secondary outcomes comprised brachial artery diameter, blood flow velocity, and Chalder Fatigue Scale (CFS).The efficacy endpoints included the change from baseline in BPE500 and BPE1000 relative to placebo, measured by FMD of the brachial artery, brachial artery diameter, and blood flow velocity at 1-and 2-hours post-dose on Day 1 and Day 7. CFS was evaluated at baseline and on Day 7 of each treatment period to measure changes in fatigue.Result: Twenty-one subjects completed three treatment periods.Both the doses of BPE showed significant improvements (p