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

按种族划分的饮食干预措施被评估为疼痛的补充治疗方法 (DIRECTPain)

• 批准号: 10512647
• 负责人: Burel R. Goodin
• 金额: $ 52.58万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-21 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10512647
• 关键词: Address; Adherence; Adoption; Adult; Analgesics; Arthritis; Behavior Therapy; Biological; Black Populations; Blood; Body Composition; Body Weight decreased; Carbohydrates; Clinical; Complementary therapies; Coupled; Degenerative polyarthritis; Diet; Dietary Intervention; Dual-Energy X-Ray Absorptiometry; Female; Fright; Future; Human Resources; Inflammation; Inflammatory; Intervention Studies; Knee Osteoarthritis; Knowledge; Leptin; Measurement; Measures; Mental Depression; Metabolic Diseases; Metabolism; Mission; Moods; National Institute on Minority Health and Health Disparities; Not Hispanic or Latino; Nutritional; Obesity; Opioid; Outcome; Oxidative Stress; Pain; Pain intensity; Pain interference; Pain management; Pain quality; Participant; Patient Self-Report; Phase; Physiological; Populations at Risk; Protocols documentation; Psychosocial Factor; Publishing; Quality of life; Race; Randomized; Reducing diet; Reporting; Risk; Risk Factors; Running; Scanning; Severities; Socioeconomic Status; Testing; Time; United States Department of Agriculture; Visceral fat; Weight; Work; alternative treatment; biopsychosocial factor; carbohydrate metabolism; chronic painful condition; daily pain; disability; efficacious treatment; efficacy evaluation; efficacy testing; experience; food insecurity; improved; insulin sensitivity; knee pain; male; non-opioid analgesic; osteoarthritis pain; pain reduction; pain relief; pain sensitivity; pain-related disability; racial difference; racial disparity; recruit; response; social

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.

按种族划分的饮食干预措施被评估为疼痛的补充治疗方法 (DIRECTPain) 项目概要 膝骨关节炎 (OA) 是最常见的关节炎形式，也是美国和世界残疾的重要原因。 种族是不良结果的一个风险因素。非西班牙裔黑人 (NHB) 报告称与 OA 相关的残疾较多 与非西班牙裔白人 (NHW) 同行相比，疼痛严重程度。这些差异进一步加剧 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。当前国家减少镇痛剂使用的努力凸显了迫切需要 为服务不足/高危人群提供安全有效的疼痛缓解替代方案。低碳水化合物饮食（LCD） 减少炎症和疼痛，与体重减轻无关，表明饮食干预提供了非 药物辅助治疗。然而，新陈代谢方面存在种族差异，这种差异很少见 在饮食干预中得到解决。 NHB 往往具有较低的胰岛素敏感性，并且患胰岛素敏感性较高的风险更大 代谢紊乱，表明碳水化合物反应改变。因此，液晶显示器可能有更大的痛苦- 减少 NHB 的影响并提供疼痛的补充（或替代）治疗。在这里，我们将招募 患有膝关节 OA 的男性和女性 NHB (n=100) 和 NHW (n=100) 成人来完成我们的两阶段方案。 第一阶段将包括为期 3 周的饮食准备，以量化疼痛指标、心理社会指标 变量（社会经济地位、营养知识、与杂货店的距离、粮食不安全）和饮食 质量提供比较基准。第 2 阶段将是为期 6 周的饮食干预（LCD 或 USDA 饮食） 将根据研究人员的指导和参与者的意见为两组提供所有膳食。 每 3 次评估一次诱发疼痛、疼痛失能、严重程度、灾难性和干扰的测量 除了 QOL 指标、情绪和抑郁症之外，还有几周的时间。生理变量将通过以下方式评估 抽血（炎症特征）和双能 X 射线吸收测定扫描（DXA；身体成分， 内脏脂肪）在第一阶段和第二阶段结束时。这将是第一项研究这些饮食对 减少膝关节骨关节炎疼痛，重点关注种族以及与生物心理社会变量的相互作用。全部变化 第 2 阶段之后的疼痛测量将根据已发布的具有临床意义的测量进行评估 疼痛和残疾的差异，以及统计显着性。中心假设是 LCD 将 改善膝关节 OA 参与者的疼痛和生活质量，NHB 的效果比 NHW 的效果更大。