Abstract

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<0.05) in mean FMD change compared to placebo as early as 1-hour post dose (BPE500- increase by 36% on Day 1 and 40% on Day 7; BPE1000-increase by 39% on Day 1 and 44% on Day 7) and lasting over 2-hour post dose (BPE500-increase by 44% on Day 1 and 43% on Day 7; BPE1000- increase by 43% on Day 1 and 48% on Day 7). There were no significant differences between BPE500 and BPE1000. Further, BPE1000 showed significant increase in blood flow velocity 2-hour post dose on Day 7. In addition, both BPE500 and BPE1000 showed significant decrease in fatigue score on Day 7. No safety issues were observed throughout the study.
Conclusion: Both BPE500 and BPE1000 showed significant efficacy in improving the flow mediated dilation, and fatigue without causing any adverse effects. The product was found to be safe and well tolerated. Further, long-term studies are required to establish the effects of BPE for energy and exercise performance.

Keywords:Beetroot; Pomegranate; Flow Mediated Dilation (FMD); Physical endurance; Athlete; Fatigue

Abbreviations: AE: Adverse Event; BMI: Body Mass Index; BPE: Beetroot and Pomegranate Extract; BPE500: Beetroot and Pomegranate Extract 500mg; BPE1000: Beetroot and Pomegranate Extract 1000mg; CFQ/CFS: Chalder Fatigue Questionnaire/Chalder Fatigue Scale; CRP: C-Reactive Protein; CTRI: Clinical Trials Registry of India; FMD: Flow-Mediated Dilation; HPLC: High-Performance Liquid Chromatography; ICAM-1: Intercellular Adhesion Molecule-1; ICMR: Indian Council of Medical Research; NF-κB: Nuclear Factor Kappa-B; NO: Nitric Oxide; NO₃⁻: Nitrate; SAE: Serious Adverse Event; SD: Standard Deviation; SE: Standard Error; TNF-α: Tumor Necrosis Factor-Alpha; UPT: Urine Pregnancy Test; VCAM-1: Vascular Cell Adhesion Molecule-1; VO₂ max: Maximal Oxygen Uptake