Diet Interventions, by Race, Evaluated as Complementary Treatments for Pain (DIRECTPain)

饮食干预，按种族划分，作为疼痛的补充治疗（DIRECTPain） 项目摘要 膝关节骨关节炎（OA）是关节炎的最普遍形式，并且是美国残疾的重要原因， 种族是不良结果的一个风险因素。非西班牙裔黑人个体（NHB）报告更大的OA相关残疾 与非西班牙裔白色（NHW）患者相比，这些差距进一步扩大 通过社会和生物机制，最终导致疼痛体验的巨大种族差异 以及相关的生活质量。目前国家减少止痛药使用的努力突出了以下方面的迫切需要： 为服务不足/高危人群提供安全有效的止痛替代品。低碳水化合物饮食（LCD） 减少炎症和疼痛，而不依赖于体重减轻，这表明饮食干预提供了一个非 药物辅助治疗。然而，在新陈代谢方面存在种族差异， 在饮食干预中得到解决。NHB倾向于具有低胰岛素敏感性， 代谢紊乱，表明碳水化合物反应改变。因此，LCD可能会有更大的痛苦- 减少对NHB的影响，并为疼痛提供补充（或替代）治疗。在这里，我们将招募 男性和女性NHB（n=100）和NHW（n=100）膝关节OA成人完成我们的两阶段方案。 第1阶段将包括为期3周的饮食准备，这将允许量化疼痛测量、心理社会测量和心理社会测量。 变量（社会经济地位、营养知识、离杂货店的距离、粮食不安全）和饮食 质量，以提供比较的基线。第2阶段将是为期6周的饮食干预（LCD或USDA饮食）， 在研究人员的指导和参与者的意见下，为两组提供所有膳食。 将每3个月评估一次诱发疼痛、疼痛残疾、严重程度、灾难性和干扰的指标 除了QOL指标，情绪和抑郁症。将通过以下方式评估生理变量： 抽血（炎症特征）和双能X射线吸收测定扫描（DXA;身体组成， 内脏脂肪）在阶段1和2结束时。这将是第一个研究这些饮食的功效， 减少膝关节OA疼痛，强调种族和与生物心理社会变量的相互作用。修订所有 将根据已发表的具有临床意义的疼痛指标评估第2阶段后的疼痛指标。 疼痛和残疾的差异，以及统计学意义。核心假设是，LCD将 改善膝关节OA受试者的疼痛和QOL，对NHB的影响大于NHW。

Diet Interventions, by Race, Evaluated as Complementary Treatments for Pain (DIRECTPain) Project Summary Knee osteoarthritis (OA) is the most prevalent form of arthritis and a significant cause of disability in the U.S. and race is a risk factor for poor outcomes. Non-Hispanic Black individuals (NHB) report greater OA-related disability and pain severity compared to their Non-Hispanic White (NHW) counterparts. These disparities are reinforced through social and biological mechanisms, ultimately resulting in dramatic racial disparities in pain experience and associated quality of life. Current national efforts to reduce analgesic utilization highlight the critical need for safe and effective alternatives for pain relief for underserved/at-risk populations. Low-carbohydrate diets (LCDs) reduce inflammation and pain independent of weight loss, indicating that diet interventions offer a non- pharmacological complementary treatment. However, racial differences exist in metabolism that are rarely addressed in diet interventions. NHBs tend to have low insulin sensitivity and are at greater risk for developing metabolic disorders, suggesting altered carbohydrate responses. Therefore, a LCD may have greater pain- reducing effects in NHBs and provide a complementary (or alternative) treatment for pain. Here, we will recruit male and female NHB (n=100) and NHW (n=100) adults with knee OA to complete our two-phase protocol. Phase 1 will involve a 3-week diet run-up that will allow for quantification of pain measures, psychosocial variables (socioeconomic status, nutritional knowledge, proximity to grocery stores, food insecurity), and diet quality to provide a baseline for comparison. Phase 2 will be a 6-week diet intervention (LCD or USDA diet) in which both groups will be provided with all meals at the direction of study personnel and input from participants. Evoked pain, measures of pain disability, severity, catastrophizing, and interference will be assessed every 3 weeks in addition to QOL measures, mood, and depression. Physiological variables will be assessed through blood draws (inflammatory profile) and dual-energy X-ray absorptiometry scans (DXA; body composition, visceral fat) at the end of Phases 1 and 2. This will be the first study to examine the efficacy of these diets to reduce knee OA pain with an emphasis on race and interactions with biopsychosocial variables. Changes in all pain measures following Phase 2 will be assessed with respect to published measures of clinically-meaningful differences in pain and disability, as well as for statistical significance. The central hypothesis is that the LCD will improve pain and QOL in participants with knee OA with a greater effect in NHBs than NHWs.