Chakraborty Hrishikesh, Sun Qi, Bhupathiraju Shilpa N, Schenk Jeannette M, Mishchuk Darya O, Bain James R, He Xuan, Sun Jianghao, Harnly James, Simmons William, Raftery Daniel, Liang Liming, Newman John W, Fiehn Oliver, Clish Clary B, Lampe Johanna W, Bennett Brian J, Navarro Sandi L, Wang Ying, Zheng Cheng, Mossavar-Rahmani Yasmin, McCullough Marjorie L, Huang Ying, Shojaie Ali, Zhu Wentao, Djukovic Danijel, Sacks Frank, Williams Jonathan, Steinberg Francene M, Adams Sean H, Hu Frank B, Neuhouser Marian L, Slupsky Carolyn M, Maruvada Padma
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, United States.
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, United States.
Curr Dev Nutr. 2025 Apr 5;9(5):107435. doi: 10.1016/j.cdnut.2025.107435. eCollection 2025 May.
Diet is a complex exposure that affects health across the lifespan. Objective biomarkers that can reliably reflect intake of nutrients, foods, and dietary patterns with sufficient accuracy are an important tool for assessing associations of diet with health outcomes. Advances in metabolomics, coupled with feeding trials and high-dimensional bioinformatics analyses, pave the way for discovering compounds that can serve as sensitive and specific biomarkers of dietary exposures. The Dietary Biomarkers Development Consortium (DBDC) is leading the first major effort to improve dietary assessment through the discovery and validation of biomarkers for foods commonly consumed in the United States diet. To achieve this goal, a 3-phase approach will be implemented to identify, evaluate, and validate food biomarkers. In phase 1, 3 controlled feeding trial designs will be implemented by administering test foods in prespecified amounts to healthy participants, followed by metabolomic profiling of blood and urine specimens collected during the feeding trials to identify candidate compounds. Data from these studies will characterize the pharmacokinetic parameters of candidate biomarkers associated with specific foods. In phase 2, the ability of candidate biomarkers to identify individuals eating the biomarker-associated foods will be evaluated using controlled feeding studies of various dietary patterns. In phase 3, the validity of candidate biomarkers to predict recent and habitual consumption of specific test foods will be evaluated in independent observational settings. Data generated during all study phases will be archived in a publicly accessible database as a resource for the research community. The DBDC aims to significantly expand the list of validated biomarkers of intake for foods consumed in the United States diet, which can help advance understanding of how diet influences human health. This manuscript discusses the DBDC's organizational infrastructure, study design, laboratory methods, and strategies for dietary biomarker discovery and validation.
This trial was registered at Phase 1 Seattle Dietary Biomarkers Development Center (P1-SDBDC) as NCT05580653, at Fruit and Vegetable Biomarker Discovery (UCD-DBDC) as NCT05621863, and at Dietary Biomarkers Intervention Core as NCT05616585.
饮食是一种复杂的暴露因素，会在整个生命周期中影响健康。能够以足够的准确性可靠地反映营养素、食物和饮食模式摄入量的客观生物标志物，是评估饮食与健康结果之间关联的重要工具。代谢组学的进展，再加上喂养试验和高维生物信息学分析，为发现可作为饮食暴露敏感且特异生物标志物的化合物铺平了道路。饮食生物标志物开发联盟（DBDC）正在牵头开展首次重大努力，通过发现和验证美国饮食中常见食物的生物标志物来改进饮食评估。为实现这一目标，将实施一个三阶段方法来识别、评估和验证食物生物标志物。在第一阶段，将实施三种对照喂养试验设计，向健康参与者给予预先规定量的测试食物，随后对喂养试验期间采集的血液和尿液样本进行代谢组学分析，以识别候选化合物。这些研究的数据将表征与特定食物相关的候选生物标志物的药代动力学参数。在第二阶段，将使用各种饮食模式的对照喂养研究来评估候选生物标志物识别食用与生物标志物相关食物个体的能力。在第三阶段，将在独立的观察环境中评估候选生物标志物预测特定测试食物近期和习惯性消费的有效性。所有研究阶段产生的数据将存档于一个可公开访问的数据库中，作为研究界的资源。DBDC旨在大幅扩充美国饮食中消费食物摄入量的已验证生物标志物清单，这有助于推动对饮食如何影响人类健康的理解。本手稿讨论了DBDC的组织架构、研究设计、实验室方法以及饮食生物标志物发现和验证的策略。
本试验在第一阶段西雅图饮食生物标志物开发中心（P1 - SDBDC）注册为NCT05580653，在水果和蔬菜生物标志物发现（UCD - DBDC）注册为NCT05621863，在饮食生物标志物干预核心注册为NCT05616585。
