Impact of Optimised Protein Intake on Household Work Limitations and Disability in Rheumatoid Arthritis
27 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
120
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Punjab
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Ludhiana, Punjab, India, 141003
- Satguru Partap Singh Hospitals
-
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Household Work Limitations measured by Household Work Limitations Questionnaire (HOWL-Q)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Manmeet Singh, MBBS, Satguru Partal Singh Hospitals
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- Linde L, Sorensen J, Ostergaard M, Horslev-Petersen K, Hetland ML. Health-related quality of life: validity, reliability, and responsiveness of SF-36, 15D, EQ-5D [corrected] RAQoL, and HAQ in patients with rheumatoid arthritis. J Rheumatol. 2008 Aug;35(8):1528-37. Epub 2008 May 15.
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- Nowson C, O'Connell S. Protein Requirements and Recommendations for Older People: A Review. Nutrients. 2015 Aug 14;7(8):6874-99. doi: 10.3390/nu7085311.
- Humayun MA, Elango R, Ball RO, Pencharz PB. Reevaluation of the protein requirement in young men with the indicator amino acid oxidation technique. Am J Clin Nutr. 2007 Oct;86(4):995-1002. doi: 10.1093/ajcn/86.4.995.
- Kianifard T, Chopra A. In the absence of specific advice, what do patients eat and avoid? Results from a community based diet study in patients suffering from rheumatoid arthritis (RA) with a focus on potassium. Clin Nutr ESPEN. 2018 Dec;28:214-221. doi: 10.1016/j.clnesp.2018.07.008. Epub 2018 Aug 14.
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de abril de 2024
Finalización primaria (Actual)
15 de septiembre de 2025
Finalización del estudio (Actual)
15 de septiembre de 2025
Fechas de registro del estudio
Enviado por primera vez
21 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de julio de 2026
Publicado por primera vez (Actual)
30 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Artritis
- Enfermedades Articulares
- Enfermedades reumáticas
- Enfermedades del tejido conectivo
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades de la piel y del tejido conectivo
- Artritis Reumatoide
- Alimento
- Dieta, alimentos y nutrición
- Fenómeno fisiológico
- Comida y bebidas
- Suplementos dietéticos
Otros números de identificación del estudio
- DMS/SPS-I/2024/96
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified participant-level data (PDF) with HAQ-DI, HOWL-Q, DAS28 category, protein intake, adherence.
Marco de tiempo para compartir IPD
21-07-2026 to 20-07-2031
Criterios de acceso compartido de IPD
Public via OSF under CC BY 4.0; citation required.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Datos del estudio/Documentos
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .