Potential pharmacological effect of Quercetin Phytosome™ in the management of hyperuricemia: results from real-life clinical studies.

IF 4 2区 农林科学 Q2 NUTRITION & DIETETICS Frontiers in Nutrition Pub Date : 2025-02-07 eCollection Date: 2025-01-01 DOI:10.3389/fnut.2025.1519459
Francesco Di Pierro, Fazle Rabbani, Meherullah Tareen, Roohi Nigar, Amjad Khan, Nicola Zerbinati, Maria L Tanda, Massimiliano Cazzaniga, Alexander Bertuccioli, Paolo Falasca, Gabriele Damiani, Nicola Villanova
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Abstract

Background: Hyperuricemia is associated with several metabolic and cardiovascular disorders, and traditional treatments, such as xanthine oxidase (XO) inhibitors, often have limitations, such as severe hypersensitivity reactions or ineffectiveness in achieving target serum urate levels in some patients. Quercetin, a naturally occurring flavonoid, has shown potential as a hypouricemic agent through XO inhibition.

Objective: This study aims to evaluate the potential hypouricemic effect of Quercetin Phytosome™ (QP) supplementation across three cohort studies involving healthy adults with various metabolic health profiles, exploring its potential as a safe, effective intervention for hyperuricemia.

Methods: Clinical data collected in various clinics in Italy between September 2021 and April 2024 under real-life clinical settings from three distinct cohort studies, were analyzed. Cohort 1 consisted of 164 healthy participants (87 QP-treated, 77 probiotic Streptococcus salivarius (S. salivarius) K12-treated) who were monitored for 90 days. Cohort 2 included 22 mildly hyperuricemic adults with metabolic disorders receiving QP, while Cohort 3 comprised 64 obese adults with hypercholesterolemia, further divided into moderately hyperuricemic QP-treated group (n = 20), a moderately hyperuricemic Berberine Phytosome™ and monacolins (BM)-treated group (n = 22), and a normouricemic BM-treated group (n = 22). QP was administered at 400 mg of quercetin daily in all cohorts. Primary endpoints were reductions in serum uric acid levels, while secondary outcomes included effects on lipid profile, glycemia, liver enzymes, and treatment tolerability.

Results: In Cohort 1, QP significantly reduced uric acid levels by 15.2% in males and 13.8% in females, with no significant changes observed in the probiotic group. Cohort 2 showed a significant 13.1% reduction in uric acid (p < 0.01) and a concurrent 10.2% reduction in triglycerides (p < 0.05). In Cohort 3, QP led to a 13.7% decrease in uric acid and a 20.8% reduction in triglycerides (p < 0.01), with no significant uric acid changes in the BM-treated group. QP was well tolerated across all cohorts, with minimal, transient side effects.

Conclusion: QP supplementation demonstrates a significant hypouricemic effect. Additionally, triglyceride-lowering benefits were evident, particularly in metabolically compromised individuals (Cohorts 2 and 3), where these effects were statistically significant. With high tolerability, these findings highlight Quercetin Phytosome™'s potential as a safe adjunctive therapy for hyperuricemia management, meriting further investigation in larger, randomized trials to confirm its efficacy and safety.

Clinical trial registration: clinicaltrials.gov, identifier NCT06652035.

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槲皮素光敏体™治疗高尿酸血症的潜在药理作用:来自现实临床研究的结果
背景:高尿酸血症与几种代谢和心血管疾病有关,传统的治疗方法,如黄嘌呤氧化酶(XO)抑制剂,通常有局限性,例如在一些患者中出现严重的超敏反应或无法达到目标血清尿酸水平。槲皮素是一种天然存在的类黄酮,通过XO抑制已显示出作为降尿酸剂的潜力。目的:本研究旨在评估槲皮素光敏体(QP)补充剂在三个队列研究中的潜在降糖作用,这些队列研究涉及具有不同代谢健康状况的健康成年人,探索其作为一种安全有效的高尿酸血症干预措施的潜力。方法:分析2021年9月至2024年4月在意大利不同诊所收集的临床数据,这些数据来自三个不同的队列研究的真实临床环境。队列1包括164名健康参与者(87名qp治疗,77名益生菌唾液链球菌k12治疗),他们被监测90天。队列2包括22名接受QP治疗的轻度高尿酸血症成人,而队列3包括64名患有高胆固醇血症的肥胖成人,进一步分为中度高尿酸血症QP治疗组(n = 20),中度高尿酸血症小檗碱植物体™和莫那可林(BM)治疗组(n = 22)和正常尿酸血症BM治疗组(n = 22)。QP在所有队列中每天给予400mg槲皮素。主要终点是血清尿酸水平的降低,次要终点包括对血脂、血糖、肝酶和治疗耐受性的影响。结果:在队列1中,QP显著降低了男性15.2%和女性13.8%的尿酸水平,而益生菌组没有观察到明显的变化。队列2显示尿酸显著降低13.1% (p < 0.01),甘油三酯同时降低10.2% (p < 0.05)。在队列3中,QP导致尿酸降低13.7%,甘油三酯降低20.8% (p < 0.01),而bm治疗组尿酸无明显变化。QP在所有队列中耐受性良好,具有最小的短暂副作用。结论:补充QP具有显著的降尿酸作用。此外,降低甘油三酯的好处是明显的,特别是在代谢受损的个体中(队列2和3),这些效果在统计学上是显著的。具有高耐受性,这些发现突出了槲皮素光敏体™作为高尿酸血症管理的安全辅助疗法的潜力,值得在更大规模的随机试验中进一步研究,以确认其有效性和安全性。临床试验注册:clinicaltrials.gov,编号NCT06652035。
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来源期刊
Frontiers in Nutrition
Frontiers in Nutrition Agricultural and Biological Sciences-Food Science
CiteScore
5.20
自引率
8.00%
发文量
2891
审稿时长
12 weeks
期刊介绍: No subject pertains more to human life than nutrition. The aim of Frontiers in Nutrition is to integrate major scientific disciplines in this vast field in order to address the most relevant and pertinent questions and developments. Our ambition is to create an integrated podium based on original research, clinical trials, and contemporary reviews to build a reputable knowledge forum in the domains of human health, dietary behaviors, agronomy & 21st century food science. Through the recognized open-access Frontiers platform we welcome manuscripts to our dedicated sections relating to different areas in the field of nutrition with a focus on human health. Specialty sections in Frontiers in Nutrition include, for example, Clinical Nutrition, Nutrition & Sustainable Diets, Nutrition and Food Science Technology, Nutrition Methodology, Sport & Exercise Nutrition, Food Chemistry, and Nutritional Immunology. Based on the publication of rigorous scientific research, we thrive to achieve a visible impact on the global nutrition agenda addressing the grand challenges of our time, including obesity, malnutrition, hunger, food waste, sustainability and consumer health.
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