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.研究背景 长期以来，石榴汁与提取物的摄入被认为具有诸多超越基础营养的健康益处，此类结论主要得到了海量临床前研究的佐证。然而，欧洲食品安全局（European Food Safety Authority, EFSA）于2010年得出结论：无法证实石榴衍生制品摄入与所有已提出的健康声称之间存在因果关联。近十年来，EFSA未再发布针对石榴相关健康声称的专项意见。 研究范围与方法 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制品摄入与健康之间因果关联的指导框架。 主要研究结果与结论 截至目前，已有86项人体研究评估了石榴汁与提取物的健康益处。尽管相关证据较为匮乏，但最具潜力的发现与血压改善相关；针对炎症、癌症、认知功能、身体活动及肠道菌群调控（益生元效应）的研究证据则相对不足。自EFSA发布意见至今已过去十年，人体研究证据仍存在不一致性，难以支撑绝大多数已宣称的健康益处。效应缺失或数据矛盾的问题，可能源于研究设计的局限性，包括产品表征不足以及个体间差异对石榴多酚生物效能的影响。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合作，以推进相关研究进展。据此，本综述提出了开展设计严谨的临床试验的路线图，旨在填补现有研究空白，为确立石榴摄入与超越基础营养的健康益处之间的因果关联提供支撑。