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.

饮食干预措施，通过种族评估为疼痛的补充治疗（直接措施） 项目摘要 膝关节骨关节炎（OA）是美国最普遍的关节炎形式，是美国和残疾的重要原因 种族是不良结果的危险因素。非西班牙裔黑人（NHB）报告了与OA相关的更大的残疾 与非西班牙裔白人（NHW）同行相比，疼痛的严重程度。这些差异得到了加强 通过社会和生物学机制，最终导致痛苦经历中的种族差异 和相关的生活质量。当前的国家减少镇痛利用的努力突出了至关重要的需求 可缓解服务不足/处于处于危险中的人群的安全有效替代方案。低碳水化合物饮食（LCD） 减轻炎症和疼痛与体重减轻无关，表明饮食干预提供了非 - 药理互补治疗。但是，种族差异在代谢中存在很少 在饮食干预中解决。 NHB的胰岛素敏感性较低，并且有更大的风险 代谢性疾病，表明碳水化合物反应改变。因此，LCD可能具有更大的疼痛 - 减少NHB的效果，并为疼痛提供互补（或替代性）治疗。在这里，我们将招募 男性和女性NHB（n = 100）和NHW（n = 100）具有膝关节OA的成年人，以完成我们的两相方案。 第1阶段将涉及3周的饮食效果 变量（社会经济状况，营养知识，靠近杂货店，粮食不安全）和饮食 提供比较基线的质量。第2阶段将是6周的饮食干预（LCD或USDA饮食） 这两组将在研究人员的方向和参与者的意见方向上提供所有餐点。 诱发疼痛，疼痛障碍，严重程度，灾难性和干扰的度量将每3次评估 除了QOL措施，情绪和抑郁症外，几周。生理变量将通过 血液抽血（炎症谱）和双能X射线吸收仪扫描（DXA；身体成分， 在第1阶段和第2阶段结束时，内脏脂肪）。这将是首次研究这些饮食功效的研究 减轻膝盖疼痛，重点是种族和与生物心理社会变量的相互作用。全部变化 第2阶段之后的疼痛度量将根据公开的临床措施评估 疼痛和残疾的差异以及统计意义。中心假设是LCD将 改善膝关节OA参与者的疼痛和QOL，在NHB中比NHWS更大。