补充尿素A改善中年肥胖患者内皮和脑血管功能：一项双盲安慰剂对照随机研究的研究方案

Q3 Nursing

Clinical Nutrition Open Science Pub Date : 2025-04-22 DOI:10.1016/j.nutos.2025.04.004

Ana Clara da C. Pinaffi-Langley , Camila B. Pinto , Zsofia Szarvas , Anna Peterfi , Zalan Kaposzta , Peter Mukli , Mihaly Muranyi , Cameron D. Owens , Cheryl Adams , Ali Shahriari , Henry Kinnard Jr. , Bryan Ticer , Leah Anderson , Stefano Tarantini , Yan Daniel Zhao , Norman G. Hord , Andriy Yabluchanskiy

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引用次数: 0

摘要

背景,目的肥胖相关的线粒体功能障碍引发并加剧了内皮功能障碍，这反过来又促进了几种疾病的发展，如心血管疾病和认知障碍。尿素A （UroA）是一种多酚衍生的微生物代谢物，具有线粒体自噬激活剂活性。虽然在人类中已经研究了补充尿a对肌肉健康的安全性、药代动力学和影响，但其减轻肥胖成人内皮功能障碍的潜力仍不清楚。因此，本方案详细介绍了一项研究的程序，该研究旨在调查补充4周尿a对中年肥胖成年人内皮和脑血管功能的影响。方法本研究采用安慰剂对照、双盲、随机、平行介入试验。符合条件的参与者年龄在40-64岁之间，BMI≥30 kg/m2。入组的参与者随机接受主动（每天1000毫克尿路素）或对照（安慰剂）干预，为期4周。在干预前后，他们接受周围微血管和大血管内皮功能和脑血管功能评估。结果我们预计，与接受安慰剂的患者相比，接受UroA补充剂的患者内皮和脑血管功能将有显著改善。结论本试验的结果将为尿路乙酸对成人肥胖患者内皮功能障碍的影响提供重要的见解。试验注册本研究于2023年6月26日在ClinicalTrials.gov （NCT05921266）前瞻性注册。

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Urolithin A supplementation to improve endothelial and cerebrovascular function in middle-aged adults with obesity: Study protocol for a double-blind placebo-controlled randomized study

Background & Aims

Obesity-related mitochondrial dysfunction initiates and exacerbates endothelial dysfunction, which in turn contributes to the development of several diseases, such as cardiovascular disease and cognitive impairment. Urolithin A (UroA) is a polyphenol-derived microbial metabolite with mitophagy activator activity. Although the safety, pharmacokinetics, and effects of UroA supplementation on muscle health have been investigated in humans, its potential to mitigate endothelial dysfunction in obese adults remains unknown. Thus, this protocol details the procedures of a study designed to investigate the effect of 4 weeks of UroA supplementation on endothelial and cerebrovascular function in middle-aged adults with obesity.

Methods

This study is a placebo-controlled, double-blind, randomized, parallel interventional trial. Eligible participants are between 40–64 years old and have a BMI ≥30 kg/m². Enrolled participants are randomized to receive active (1,000 mg of UroA daily) or control (placebo) intervention for 4 weeks. Before and after the intervention, they undergo peripheral micro- and macrovascular endothelial function and cerebrovascular function assessments.

Results

We expect that those who receive UroA supplementation will have a significant improvement in endothelial and cerebrovascular function compared with those who receive placebo.