Impact of Optimised Protein Intake on Household Work Limitations and Disability in Rheumatoid Arthritis
2026年7月27日 更新者：Satguru Partap Singh Hospitals
The goal of this clinical trial is to learn if optimised protein intake improves household work capacity and overall functional status in women with rheumatoid arthritis. It will also assess the safety and tolerability of dietary protein supplementation. The main questions it aims to answer are:
Does optimised protein intake reduce household work limitations measured by the Household Work Limitations Questionnaire (HOWL-Q)?
Does optimised protein intake improve overall functional disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)?
What side effects or tolerability issues do participants experience with dietary protein modification and supplementation?
Researchers compared participants receiving structured dietary counselling and protein supplementation (targeting 1.0 g/kg/day) to their baseline protein intake to determine if the intervention improves functional outcomes in women with stable rheumatoid arthritis on disease-modifying antirheumatic drugs.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
120
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
-
-
Punjab
-
Ludhiana、Punjab、印度、141003
- Satguru Partap Singh Hospitals
-
-
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
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
Women aged equal to or more than 18 years with rheumatoid arthritis diagnosed according to American College of Rheumatology/European League Against Rheumatism 2010 criteria
Exclusion Criteria:
Males
Unstable disease requiring DMARD modification during the study period
Overlap connective tissue disease
Chronic kidney disease stage 3 or above
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：支持治疗
- 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 |
|---|---|
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实验性的：Protein Optimisation Improves Household Work and Functional Status in RA
Participants received a 12-week dietary intervention comprising two components: (1) Individualised dietary counselling in preferred language (Hindi, Punjabi, or English) promoting increased protein-rich foods including plant-based sources (legumes, soybean, nuts, seeds) and animal-based sources (eggs, milk, yogurt, paneer, meat, fish) within cultural dietary preferences; (2) Commercial protein supplementation (whey protein isolate 20-25g per serving or fortified nutritional beverages ≥15g protein per serving) for participants demonstrating resistance to dietary modification alone.
Intervention targeted 1.0 g/kg/day protein intake.
All participants maintained unchanged disease-modifying antirheumatic drug regimens throughout.
Assessments performed at baseline and 12 weeks.
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Dietary Protein Optimisation Intervention targeting 1.0 g/kg/day.
Two components: (1) Individualised dietary counselling promoting increased protein-rich foods including legumes, soybean, nuts, seeds, eggs, milk, yogurt, paneer, and fish, tailored to cultural dietary preferences and delivered in Hindi, Punjabi, or English; (2) Commercial protein supplementation (whey protein isolate 20-25g/serving or fortified nutritional beverages ≥15g protein/serving) for participants with dietary modification resistance.
Administered over 12 weeks.
All participants maintained stable disease-modifying antirheumatic drug regimens throughout.
Dietary assessment via 3-day recall at baseline and 7-day recall at 12 weeks.
其他名称：
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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 |
|---|---|---|
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Change in Household Work Limitations measured by Household Work Limitations Questionnaire (HOWL-Q)
大体时间：12 weeks
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Household Work Limitations measured using Household Work Limitations Questionnaire (HOWL-Q).
A 41-item instrument assessing functional limitations across five domains: housekeeping, object interaction, care for others, personal motion and transportation, and manual dexterity.
Each item scored 0-3; domain scores calculated as highest item score per domain; global HOWL-Q score transformed to 0-10 scale (0=best, 10=worst).
Primary outcome: change from baseline to 12 weeks.
HOWL-Q captures household-specific functional limitations not measured by generic disability scales (HAQ-DI), directly relevant to women's household responsibilities and quality of life.
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12 weeks
|
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Change in Overall Functional Disability measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)
大体时间：12 weeks
|
Overall Functional Disability measured using Health Assessment Questionnaire-Disability Index (HAQ-DI).
An 8-domain self-report instrument measuring disability across dressing, arising, eating, walking, hygiene, reach, grip, and activities of daily living.
Each domain scored 0-3; final score calculated as mean of eight domains (range 0-3), with lower scores indicating better function.
Minimally clinically important difference 0.22 points.
Primary outcome: change from baseline to 12 weeks.
HAQ-DI demonstrates excellent test-retest reliability (intraclass correlation >0.95) and internal consistency (Cronbach's alpha >0.90), established as standard functional disability measure in rheumatoid arthritis research.
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12 weeks
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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：Manmeet Singh, MBBS、Satguru Partal Singh Hospitals
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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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)
2024年4月1日
初级完成 (实际的)
2025年9月15日
研究完成 (实际的)
2025年9月15日
研究注册日期
首次提交
2026年7月21日
首先提交符合 QC 标准的
2026年7月27日
首次发布 (实际的)
2026年7月30日
研究记录更新
最后更新发布 (实际的)
2026年7月30日
上次提交的符合 QC 标准的更新
2026年7月27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
- DMS/SPS-I/2024/96
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
De-identified participant-level data (PDF) with HAQ-DI, HOWL-Q, DAS28 category, protein intake, adherence.
IPD 共享时间框架
21-07-2026 to 20-07-2031
IPD 共享访问标准
Public via OSF under CC BY 4.0; citation required.
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
研究数据/文件
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.