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.
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
This is an open-label, unmasked study. Participants were aware they were receiving dietary counselling and protein supplementation. Care providers administered the intervention openly. Investigators and outcomes assessors were not blinded to group assignment. No blinding was possible due to the nature of the dietary intervention.
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.
Ludhiana, Punjab 141003, India
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