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A healthier approach to clinical trials evaluating resveratrol for primary prevention of age-related diseases in healthy populations

机译:评价白藜芦醇对健康人群中与年龄有关的疾病的一级预防的更健康的临床试验方法

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摘要

In recent years, the wealth of basic science research supporting resveratrol's potential to treat, delay, and even prevent age-related chronic diseases has led to a number of human clinical trials. While such translational research has yielded promising results in clinical populations, recently published conflicting results from studies evaluating resveratrol's potential for primary prevention of chronic disease in healthy / asymptomatic individuals have generated considerable controversy and do not initially appear consistent with findings from animal models. We argue that trials targeting healthy humans are often fundamentally flawed owing to inappropriate use of paradigms only applicable to populations with overt clinical disease and the consequent misleading (typically negative) results can severely retard advancement of drug development. To appropriately perform translational research centered on resveratrol as a primary prevention agent in non-clinical populations, it is critical to utilize study designs which can provide adequate information on clinically relevant outcome measures, avoid paradigms and assumptions from interventions which are specific to clinical populations, and maintain realistic expectations compared to interventions which provide the theoretical maximal response (e.g., caloric restriction and aerobic exercise training).
机译:近年来,大量支持白藜芦醇治疗,延缓甚至预防与年龄有关的慢性病的潜力的基础科学研究已经导致了许多人体临床试验。尽管此类转化研究在临床人群中产生了可喜的结果,但最近发表的有关评估白藜芦醇在健康/无症状个体中初步预防慢性疾病的潜力的研究得出的相互矛盾的结果引起了很大争议,并且最初与动物模型的发现不一致。我们认为,针对健康人的试验通常存在根本性缺陷,因为不适当地使用仅适用于具有明显临床疾病的人群的范例,因此产生的误导性(通常为阴性)结果会严重阻碍药物开发的进展。为了在非临床人群中适当开展以白藜芦醇为主要预防剂的转化研究,至关重要的是,利用能够提供有关临床相关结果指标的足够信息,避免针对临床人群的干预措施的范例和假设的研究设计,与提供理论上最大反应的干预措施(例如,热量限制和有氧运动训练)相比,并保持切合实际的期望。

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