Rheumatoid Arthritis (RA)NCT07737119
Impact of Optimised Protein Intake on Household Work Limitations and Disability in Rheumatoid Arthritis
A study testing Protein Optimisation through Dietary Counselling and Supplementation in people with Rheumatoid Arthritis (RA), run by Satguru Partap Singh Hospitals at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Protein Optimisation through Dietary Counselling and Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2024to 15 Sep 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Males
- Unstable disease requiring DMARD modification during the study period
- Overlap connective tissue disease
- Chronic kidney disease stage 3 or above
Trial locations and contacts
1 site in 1 country.
About this study
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)?
Read more
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.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Protein Optimisation through Dietary Counselling and Supplementation
- Keywords
- Indian patients, RA India, Protein Intake in Punjab, Household work limitiations
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein Optimisation through Dietary Counselling and SupplementationDietary supplement
Also called Dietary Protein Optimisation
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.
| Study group | Role | What they receive |
|---|---|---|
| Protein Optimisation Improves Household Work and Functional Status in RA | Experimental | 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. Receives: Dietary Supplement: Protein Optimisation through Dietary Counselling and Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Household Work Limitations measured by Household Work Limitations Questionnaire (HOWL-Q)
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.
Measured: 12 weeks
Change in Overall Functional Disability measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Apr 2024
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm prospective intervention study. All 120 women with rheumatoid arthritis received 12-week dietary counselling and protein supplementation targeting 1.0 g/kg/day. Assessments performed at baseline and 12 weeks. Primary outcomes measured using Health Assessment Questionnaire-Disability Index (HAQ-DI) and Household Work Limitations Questionnaire (HOWL-Q). No control group. All participants maintained stable disease-modifying antirheumatic drug regimens throughout.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satguru Partap Singh Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manmeet Singh, MBBS, Principal investigator, Satguru Partal Singh Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737119
- Sponsor's protocol ID
- DMS/SPS-I/2024/96
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data (PDF) with HAQ-DI, HOWL-Q, DAS28 category, protein intake, adherence.
Publications
Zhao T, Wei Y, Zhu Y, Xie Z, Hai Q, Li Z, Qin D. Gut microbiota and rheumatoid arthritis: From pathogenesis to novel therapeutic opportunities. Front Immunol. 2022 Sep 8;13:1007165. doi: 10.3389/fimmu.2022.1007165. eCollection 2022.
PubMed 36159786Roubenoff R. Rheumatoid cachexia: a complication of rheumatoid arthritis moves into the 21st century. Arthritis Res Ther. 2009;11(2):108. doi: 10.1186/ar2658. Epub 2009 Apr 27.
PubMed 19439037Schiaffino S, Reggiani C. Fiber types in mammalian skeletal muscles. Physiol Rev. 2011 Oct;91(4):1447-531. doi: 10.1152/physrev.00031.2010.
PubMed 22013216Pope JE, Khanna D, Norrie D, Ouimet JM. The minimally important difference for the health assessment questionnaire in rheumatoid arthritis clinical practice is smaller than in randomized controlled trials. J Rheumatol. 2009 Feb;36(2):254-9. doi: 10.3899/jrheum.080479.
PubMed 19132791Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: dimensions and practical applications. Health Qual Life Outcomes. 2003 Jun 9;1:20. doi: 10.1186/1477-7525-1-20.
PubMed 12831398Linde 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.
PubMed 18484697Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, Aletaha D, van Riel PL. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009 Jun;68(6):954-60. doi: 10.1136/ard.2007.084459. Epub 2008 May 19.
PubMed 18490431Wells GA, Tugwell P, Kraag GR, Baker PR, Groh J, Redelmeier DA. Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. J Rheumatol. 1993 Mar;20(3):557-60.
PubMed 8478873Raad T, George E, Griffin A, Larkin L, Fraser A, Kennedy N, Tierney A. Effects of a telehealth-delivered Mediterranean diet intervention in adults with Rheumatoid Arthritis (MEDRA): a randomised controlled trial. BMC Musculoskelet Disord. 2024 Aug 7;25(1):631. doi: 10.1186/s12891-024-07742-1.
PubMed 39112976Snekhalatha U, Anburajan M. Evaluation of functional ability of rheumatoid arthritis based on HAQ score and BMD among South Indian patients. Rheumatol Int. 2012 Jul;32(7):1997-2004. doi: 10.1007/s00296-011-1906-y. Epub 2011 Apr 5.
PubMed 21465315Kumar A, Malaviya AN, Pandhi A, Singh R. Validation of an Indian version of the Health Assessment Questionnaire in patients with rheumatoid arthritis. Rheumatology (Oxford). 2002 Dec;41(12):1457-9. doi: 10.1093/rheumatology/41.12.1457. No abstract available.
PubMed 12468833Bostan ZZ, Sare Bulut M, Ozen Unaldi B, Albayrak Buhurcu C, Akbulut G. Effect of Plant-Based Diets on Rheumatoid Arthritis: A Systematic Review. Nutr Rev. 2025 Jul 1;83(7):e1798-e1814. doi: 10.1093/nutrit/nuae181.
PubMed 39786551Tedeschi SK, Frits M, Cui J, Zhang ZZ, Mahmoud T, Iannaccone C, Lin TC, Yoshida K, Weinblatt ME, Shadick NA, Solomon DH. Diet and Rheumatoid Arthritis Symptoms: Survey Results From a Rheumatoid Arthritis Registry. Arthritis Care Res (Hoboken). 2017 Dec;69(12):1920-1925. doi: 10.1002/acr.23225.
PubMed 28217907Forsyth C, Kouvari M, D'Cunha NM, Georgousopoulou EN, Panagiotakos DB, Mellor DD, Kellett J, Naumovski N. The effects of the Mediterranean diet on rheumatoid arthritis prevention and treatment: a systematic review of human prospective studies. Rheumatol Int. 2018 May;38(5):737-747. doi: 10.1007/s00296-017-3912-1. Epub 2017 Dec 18.
PubMed 29256100McDougall J, Bruce B, Spiller G, Westerdahl J, McDougall M. Effects of a very low-fat, vegan diet in subjects with rheumatoid arthritis. J Altern Complement Med. 2002 Feb;8(1):71-5. doi: 10.1089/107555302753507195.
PubMed 11890437