慢性肾脏病的多元文化健康饮食
2026年7月17日 更新者：Montefiore Medical Center
多元文化健康饮食（抗炎饮食模式）在患有慢性肾脏病的少数民族中的可行性和可接受性
这是一项试点干预研究，旨在评估针对慢性肾病参与者进行文化定制的抗炎饮食干预的可行性和可接受性。
研究概览
详细说明
这是一项试验性事前事后比较干预研究，旨在评估针对文化定制的抗炎饮食干预的可行性和可接受性。
该研究将从布朗克斯的肾脏科诊所招募 20 名患有慢性肾病 (CKD) 的成年参与者。
饮食强调限制动物和高饱和脂肪食物，重点是针对参与者文化背景的抗炎食物/食物成分。
饮食也将根据 CKD 人群的需求量身定制，包括关注降低钠摄入量。
干预将由经验丰富的营养师提供，该营养师具有为 CKD 患者提供饮食咨询的专业知识。
研究小组将通过膳食摄入量评估、问卷调查和血清生物标志物评估该饮食对 CKD 患者是否可行、可接受和安全。
来自研究的信息将有助于为未来旨在改善 CKD 结果的大规模研究的研究设计和干预提供信息。
拟议研究的临床地点位于阿尔伯特爱因斯坦医学院和蒙蒂菲奥里医学中心。
研究类型
介入性
注册 (实际的)
18
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
New York
-
The Bronx、New York、美国、10461
- Montefiore Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 年龄≥18岁
- CKD 3 期（估计肾小球滤过率 (GFR) < 60 - >30 ml/min/1.73m2）
- 居住在布朗克斯区
- 说英语或西班牙语
- 提供书面知情同意书
排除标准：
- 高钾血症病史，或基线血清钾 > 4.6
- CKD 4 期或更高阶段（eGFR <30 ml/min/1.73 平方米）
- 不愿意改变饮食
- 肾移植史
- 糖尿病控制不佳 (HbA1c >9%) 或使用胰岛素
- 未控制的高血压（BP >150 /90 mmHg）
- 任何严重的慢性疾病、低识字率或其他无法改变饮食或完成学习活动的情况
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：所有参与者都将接受干预
|
基于食物的成分将类似于正在进行的 MHD 研究 (NCT03240406) 的抗炎饮食，该研究强调限制动物和高饱和脂肪食物，重点是针对参与者文化背景的抗炎食物/食物成分.
饮食也将根据 CKD 人群的需求量身定制，包括关注降低钠摄入量。
干预（饮食咨询）将由经验丰富的肾病营养师提供。
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility of Dietary Intervention
大体时间：From baseline (pre-intervention) to 2 months (post-intervention)
|
Feasibility will be assessed using the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool and the Energy-Adjusted Dietary Inflammatory Index (E-DII®). The ASA24® is a web-based tool that enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records (i.e., food diaries). The Energy Adjusted Dietary Inflammatory Index (E-DII®) quantifies the inflammatory potential of a person's diet while adjusting for total energy intake. Scores range from -8.87 (maximally anti-inflammatory) to +7.98 (maximally pro-inflammatory). Higher (positive) scores indicate greater adherence to a pro-inflammatory dietary pattern (e.g., highly processed or fried foods, sugary beverages) and are associated with poorer health outcomes, whereas lower (negative) scores indicate greater adherence to an anti-inflammatory dietary pattern (e.g., leafy greens, fruits, fish) and are associated with better health outcomes. |
From baseline (pre-intervention) to 2 months (post-intervention)
|
|
Acceptability of Dietary Intervention
大体时间：2 months post baseline
|
Acceptability of the dietary intervention will be assessed using the Acceptability of the Multicultural Healthy Diet (MHD) in CKD questionnaire.
Participants will be asked to rate acceptability based on five items regarding whether the dietary intervention met their approval; was appealing; whether they liked the diet, in general; liked using herbs/spices that they had not used before; and would recommend the diet to family/friends.
Responses to each item are rated on a 5-point ordinal scale: (Completely disagree, Disagree, Neither agree nor disagree, Agree or Completely agree).
The number/percentage of participants selecting each category will be tabulated.
|
2 months post baseline
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Potassium Level
大体时间：2-4 weeks after first session with nutritionist (onset of intervention)
|
A serum potassium will be assessed 2-4 weeks after starting the diet as an added safety measure.
Results are summarized in milliequivalents/liter (mEq/L).
|
2-4 weeks after first session with nutritionist (onset of intervention)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Tanya Johns, MD、Montefiore Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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- Vilaysane A, Chun J, Seamone ME, Wang W, Chin R, Hirota S, Li Y, Clark SA, Tschopp J, Trpkov K, Hemmelgarn BR, Beck PL, Muruve DA. The NLRP3 inflammasome promotes renal inflammation and contributes to CKD. J Am Soc Nephrol. 2010 Oct;21(10):1732-44. doi: 10.1681/ASN.2010020143. Epub 2010 Aug 5.
- Christ A, Gunther P, Lauterbach MAR, Duewell P, Biswas D, Pelka K, Scholz CJ, Oosting M, Haendler K, Bassler K, Klee K, Schulte-Schrepping J, Ulas T, Moorlag SJCFM, Kumar V, Park MH, Joosten LAB, Groh LA, Riksen NP, Espevik T, Schlitzer A, Li Y, Fitzgerald ML, Netea MG, Schultze JL, Latz E. Western Diet Triggers NLRP3-Dependent Innate Immune Reprogramming. Cell. 2018 Jan 11;172(1-2):162-175.e14. doi: 10.1016/j.cell.2017.12.013.
- Baer DJ, Judd JT, Clevidence BA, Tracy RP. Dietary fatty acids affect plasma markers of inflammation in healthy men fed controlled diets: a randomized crossover study. Am J Clin Nutr. 2004 Jun;79(6):969-73. doi: 10.1093/ajcn/79.6.969.
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- Farhadnejad H, Asghari G, Mirmiran P, Yuzbashian E, Azizi F. Micronutrient Intakes and Incidence of Chronic Kidney Disease in Adults: Tehran Lipid and Glucose Study. Nutrients. 2016 Apr 20;8(4):217. doi: 10.3390/nu8040217.
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- Kim H, Caulfield LE, Garcia-Larsen V, Steffen LM, Grams ME, Coresh J, Rebholz CM. Plant-Based Diets and Incident CKD and Kidney Function. Clin J Am Soc Nephrol. 2019 May 7;14(5):682-691. doi: 10.2215/CJN.12391018. Epub 2019 Apr 25.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年11月3日
初级完成 (实际的)
2024年12月31日
研究完成 (实际的)
2024年12月31日
研究注册日期
首次提交
2022年8月15日
首先提交符合 QC 标准的
2022年8月15日
首次发布 (实际的)
2022年8月17日
研究记录更新
最后更新发布 (实际的)
2026年8月11日
上次提交的符合 QC 标准的更新
2026年7月17日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2021-12753
- K23DK124644-01A1 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.