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COMPLETED
NCT07737119
NA

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

Sponsor: Satguru Partap Singh Hospitals

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-04-01

Completion Date

2025-09-15

Last Updated

2026-07-30

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Protein Optimisation through Dietary Counselling and Supplementation

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.

Locations (1)

Satguru Partap Singh Hospitals

Ludhiana, Punjab, India