Impact of Optimised Protein Intake on Household Work Limitations and Disability in Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Satguru Partap Singh Hospitals

Ludhiana, Punjab, 141003, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein Optimisation through Dietary Counselling and Supplementation

Dietary Supplement

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.

Other names: Dietary Protein Optimisation

Primary outcomes

Change in Household Work Limitations measured by Household Work Limitations Questionnaire (HOWL-Q)

Time frame: 12 weeks

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.
Change in Overall Functional Disability measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Satguru Partap Singh Hospitals

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 30, 2026
Registry last updated: Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed