Common Limitations and Challenges of Dietary Clinical Trials for Translation into Clinical Practices.

IF 2.1 Q3 ENDOCRINOLOGY & METABOLISM International Journal of Endocrinology and Metabolism Pub Date : 2021-05-01 eCollection Date: 2021-07-01 DOI:10.5812/ijem.108170
Parvin Mirmiran, Zahra Bahadoran, Zahra Gaeini
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引用次数: 27

Abstract

The progressive development of clinical and public health nutrition has long relied on dietary clinical trials (DCTs), investigating the causal relationship between diet and multiple risk factors of non-communicable and chronic diseases. DCTs are also hallmarks for establishing dietary requirements and promoting overall nutritional health among the population. Despite their critical importance in translation into public health strategies and practices, DCTs have several limitations and challenges for study design, implementation and finding interpretation. The complex nature of nutrition interventions, collinearity between diet components, multi-target effects of the interventions, diverse dietary behaviors, and food culture are the most challenging issues. Furthermore, baseline exposure and dietary status, appropriate control groups, blinding, randomization, and poor adherence undermine the effectiveness of DCTs in translation into practices. Disruptive factors will be minimized if researchers are committed to following good clinical practice (GCP) standards available for common designs of clinical trials. Planning DCTs, however, needs careful considerations for hypothesis generation, study design development, the definition of primary and secondary outcome measures, and target population.

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饮食临床试验转化为临床实践的常见限制和挑战。
长期以来,临床和公共卫生营养学的逐步发展一直依赖于膳食临床试验(dct),研究饮食与非传染性疾病和慢性疾病的多种危险因素之间的因果关系。dct也是确定膳食需求和促进人口整体营养健康的标志。尽管dct在转化为公共卫生战略和实践方面至关重要,但在研究设计、实施和寻找解释方面存在一些限制和挑战。营养干预的复杂性、饮食成分之间的共线性、干预的多目标效应、多样化的饮食行为和饮食文化是最具挑战性的问题。此外,基线暴露和饮食状况、适当的对照组、盲法、随机化和依从性差都会破坏dct转化为实践的有效性。如果研究人员致力于遵循临床试验通用设计的良好临床实践(GCP)标准,破坏性因素将被最小化。然而,规划dct需要仔细考虑假设的产生、研究设计的发展、主要和次要结果测量的定义以及目标人群。
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来源期刊
CiteScore
3.10
自引率
4.80%
发文量
0
期刊介绍: The aim of the International Journal of Endocrinology and Metabolism (IJEM) is to increase knowledge, stimulate research in the field of endocrinology, and promote better management of patients with endocrinological disorders. To achieve this goal, the journal publishes original research papers on human, animal and cell culture studies relevant to endocrinology.
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