[1] 付佳, 杨月欣. 食物健康声称—欧洲PASSCLAIM的循证程序[J]. 中国食品卫生杂志, 2007, 3:280–283. [2] Woodside JV, Welch RW, Patterson CC, et al. Study design: intervention studies[M]//Lovegrove J A, Hodson L, Sharma S. Nutrition research methodologies. Hoboken: Wiley-Blackwell, 2015:28–47. [3] Martínez-López.E, Pérez-Guerrero. EE, Torres-Carrillo NM, et al. Methodological aspects in randomized clinical trials of nutritional interventions[J]. Nutrients, 2022, 14:1–19. [4] Petersen KS, Kris-Etherton PM, McCabe GP, et al. Perspective: planning and conducting statistical analyses for human nutrition randomized controlled trials: ensuring data quality and integrity[J]. Adv Nutr, 2021, 12:1610–1624. [5] Rigutto-Farebrother J, Ahles S, Cade J, et al. Perspectives on the application of consort guidelines to randomised controlled trials in nutrition[J]. Eur J Nutr, 2023, 62:2319–2332. [6] Anderson SF.Best (but oft forgotten) practices: sample size planning for powerful studies[J]. Am J Clin Nutr, 2019, 110:280–295. [7] Browner WS, Newman TB, Pletcher MJ.Getting ready to estimate sample size[M]//Cho J, Winter A S. Designing clinical research. Philadelphia: LWW, 2022:108–128. [8] Zhang W, Liu A, Zhang Z, et al. Best (but oft-forgotten) practices: sample size and power calculation for a dietary intervention trial with episodically consumed foods[J]. Am J Clin Nutr, 2020, 112:920–925. [9] Candel M, van Breukelen GJP. Best (but oft forgotten) practices: efficient sample sizes for commonly used trial designs[J]. Am J Clin Nutr, 2023, 117:1063–1085. [10] Welch RW, Antoine JM, Berta JL, et al. Guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods[J]. Br J Nutr, 2011, 106(Suppl 2):S3–S15. [11] Staudacher HM, Yao CK, Chey WD, et al. Optimal design of clinical trials of dietary interventions in disorders of gut-brain interaction[J]. Am J Gastroenterol, 2022, 117:973–984. [12] Frestedt J.Similarities and difference between clinical trials for foods and drugs[J]. Austin J Nutr Food Sci, 2017, 5:1086–1093. [13] Lichtenstein AH, Petersen K, Barger K, et al. Perspective: design and conduct of human nutrition randomized controlled trials[J].Adv Nutr, 2021, 12:4–20. [14] 国家卫生和计划生育委员会. 食品生产通用卫生规范[S]. 2013. [15] 赵晶晶, 龙泳, 刘学东. 2013临床试验方案规范指南(SPIRIT)及其解读[J].中国循证儿科杂志, 2014, 9:381–388. [16] 王波, 詹思延, 孙凤, 等. 营养干预的循证评价:对现有循证评价方法的系统综述与评价[J]. 中华流行病学杂志, 2010, 31:1062–1067. [17] 国家卫生健康委, 教育部, 科技部. 涉及人的生命科学和医学研究伦理审查办法[Z].2023. [18] 中华人民共和国科学技术部.人类遗传资源管理条例实施细则[Z].2023. [19] 中华人民共和国人类遗传资源管理条例[J]. 中华人民共和国国务院公报, 2019, 18:29–35. [20] Weaver CM, Miller JW.Challenges in conducting clinical nutrition research[J]. Nutr Rev, 2017, 75:491–499. [21] Laville M, Segrestin B, Alligier M, et al. Evidence-based practice within nutrition: what are the barriers for improving the evidence and how can they be dealt with?[J]. Trials, 2017, 18:425–433. [22] Mattes RD, Rowe SB, Ohlhorst SD, et al. Valuing the diversity of research methods to advance nutrition science[J]. Adv Nutr, 2022, 13:1324–1393.
