Human studies carried out with pomegranate-based products (juice and extract).

Background The consumption of pomegranate juices and extracts has long been linked to many health benefits beyond nutrition, described mainly by innumerable preclinical studies. However, the European Food Safety Authority (EFSA) concluded in 2010 that a cause and effect relationship could not be established between the consumption of pomegranate-derived products and all the health claims presented. There are no additional EFSA opinions on health claims specifically addressed to pomegranate in the last decade. Scope and approach This review comprehensively compiles all human studies conducted on pomegranate. The aim is to discuss these studies critically to identify possible flaws and propose guidelines that might help establish a cause and effect relationship between pomegranate-derived product consumption and health. Key findings and conclusions To date, 86 human studies have evaluated the health benefits of pomegranate juices and extracts. The most promising, albeit scarce, evidence is related to blood pressure improvement. Less evidence deals with inflammation, cancer, cognitive function, physical activity, and gut microbiota modulation (prebiotic effects). After a decade since EFSA's opinion, human evidence remains inconsistent, making it difficult to support most claimed health effects. The lack of effects and(or) data discrepancy might be attributable to design limitations, including insufficient product characterization and interindividual variability that influence pomegranate polyphenols' bioefficacy. New coordinated strategies between policy makers, research/academic institutions, and industry are needed to move forward. Therefore, this review presents a roadmap to conduct well-designed trials and cover existing gaps, which could establish a cause-effect relation between pomegranate consumption and health benefits beyond nutrition.背景 长期以来，石榴汁及其提取物的摄入被认为具备诸多超出营养范畴的健康益处，相关结论主要来自海量临床前研究。然而，欧洲食品安全局（European Food Safety Authority，EFSA）2010年发布的结论指出，无法确立石榴衍生产品摄入与所提出的全部健康声称之间的因果关系。近十年来，EFSA未再发布针对石榴的健康声称相关专项意见。 范围与研究方法 本综述全面梳理了所有已开展的石榴相关人体研究，旨在批判性评析这些研究以识别潜在缺陷，并提出有助于确立石榴衍生产品摄入与健康之间因果关系的指导原则。 主要研究结果与结论 截至目前，已有86项人体研究对石榴汁及提取物的健康益处进行了评估。其中最具潜力（尽管相关证据仍较为匮乏）的关联为血压改善；针对炎症、癌症、认知功能、体力活动以及肠道菌群调控（益生元效应）的研究证据则相对有限。自EFSA发布上述意见已过去十年，当前人体研究证据仍存在不一致性，难以支持绝大多数已声称的健康效应。效应缺失或（及）数据不一致的原因可能包括研究设计局限，例如产品表征不足以及个体间差异影响石榴多酚的生物功效。未来需推动政策制定者、科研/学术机构与产业界之间的协同策略，以推进相关研究进展。因此，本综述提出了开展高质量试验的路线图，并填补现有研究空白，从而有望确立石榴摄入与超出营养范畴的健康益处之间的因果关系。