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

NCT07737119 | Completed

• 1 other identifier: DMS/SPS-I/2024/96
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

Indian patients; RA India; Protein Intake in Punjab; Household work limitiations

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Study Arms (1)

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.

Dietary Supplement: Protein Optimisation through Dietary Counselling and Supplementation

Interventions

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.

Also known as: Dietary Protein Optimisation

Protein Optimisation Improves Household Work and Functional Status in RA

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Males
• Unstable disease requiring DMARD modification during the study period
• Overlap connective tissue disease
• Chronic kidney disease stage 3 or above

Sponsors & Collaborators

• Satguru Partap Singh Hospitals: lead

Study Sites (1)

Satguru Partap Singh Hospitals

Ludhiana, Punjab, 141003, India

Location

Related Publications (34)

• 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.

  PMID: 36159786 BACKGROUND

• Roubenoff 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.

  PMID: 19439037 BACKGROUND

• Schiaffino S, Reggiani C. Fiber types in mammalian skeletal muscles. Physiol Rev. 2011 Oct;91(4):1447-531. doi: 10.1152/physrev.00031.2010.

  PMID: 22013216 BACKGROUND

• Pope 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.

  PMID: 19132791 BACKGROUND

• Bruce 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.

  PMID: 12831398 BACKGROUND

• 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.

  PMID: 18484697 BACKGROUND

• Wells 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.

  PMID: 18490431 BACKGROUND

• Wells 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.

  PMID: 8478873 BACKGROUND

• Raad 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.

  PMID: 39112976 BACKGROUND

• Snekhalatha 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.

  PMID: 21465315 BACKGROUND

• Kumar 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.

  PMID: 12468833 BACKGROUND

• Bostan 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.

  PMID: 39786551 BACKGROUND

• Tedeschi 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.

  PMID: 28217907 BACKGROUND

• Forsyth 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.

  PMID: 29256100 BACKGROUND

• McDougall 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.

  PMID: 11890437 BACKGROUND

• Hafstrom I, Ringertz B, Spangberg A, von Zweigbergk L, Brannemark S, Nylander I, Ronnelid J, Laasonen L, Klareskog L. A vegan diet free of gluten improves the signs and symptoms of rheumatoid arthritis: the effects on arthritis correlate with a reduction in antibodies to food antigens. Rheumatology (Oxford). 2001 Oct;40(10):1175-9. doi: 10.1093/rheumatology/40.10.1175.

  PMID: 11600749 BACKGROUND

• Sharma M, Kishore A, Roy D, Joshi K. A comparison of the Indian diet with the EAT-Lancet reference diet. BMC Public Health. 2020 May 29;20(1):812. doi: 10.1186/s12889-020-08951-8.

  PMID: 32471408 BACKGROUND

• Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol. 2003 Jan;30(1):167-78.

  PMID: 12508408 BACKGROUND

• Remans PH, Sont JK, Wagenaar LW, Wouters-Wesseling W, Zuijderduin WM, Jongma A, Breedveld FC, Van Laar JM. Nutrient supplementation with polyunsaturated fatty acids and micronutrients in rheumatoid arthritis: clinical and biochemical effects. Eur J Clin Nutr. 2004 Jun;58(6):839-45. doi: 10.1038/sj.ejcn.1601883.

  PMID: 15164103 BACKGROUND

• Picchianti Diamanti A, Panebianco C, Salerno G, Di Rosa R, Salemi S, Sorgi ML, Meneguzzi G, Mariani MB, Rai A, Iacono D, Sesti G, Pazienza V, Lagana B. Impact of Mediterranean Diet on Disease Activity and Gut Microbiota Composition of Rheumatoid Arthritis Patients. Microorganisms. 2020 Dec 14;8(12):1989. doi: 10.3390/microorganisms8121989.

  PMID: 33327432 BACKGROUND

• Theis KA, Steinweg A, Helmick CG, Courtney-Long E, Bolen JA, Lee R. Which one? What kind? How many? Types, causes, and prevalence of disability among U.S. adults. Disabil Health J. 2019 Jul;12(3):411-421. doi: 10.1016/j.dhjo.2019.03.001. Epub 2019 Mar 28.

  PMID: 31000498 BACKGROUND

• Mikkelsen UR, Dideriksen K, Andersen MB, Boesen A, Malmgaard-Clausen NM, Sorensen IJ, Schjerling P, Kjaer M, Holm L. Preserved skeletal muscle protein anabolic response to acute exercise and protein intake in well-treated rheumatoid arthritis patients. Arthritis Res Ther. 2015 Sep 25;17:271. doi: 10.1186/s13075-015-0758-3.

  PMID: 26407995 BACKGROUND

• 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.

  PMID: 26287239 BACKGROUND

• 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.

  PMID: 17921376 BACKGROUND

• 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.

  PMID: 30390884 BACKGROUND

• Robinson SM, Reginster JY, Rizzoli R, Shaw SC, Kanis JA, Bautmans I, Bischoff-Ferrari H, Bruyere O, Cesari M, Dawson-Hughes B, Fielding RA, Kaufman JM, Landi F, Malafarina V, Rolland Y, van Loon LJ, Vellas B, Visser M, Cooper C; ESCEO working group. Does nutrition play a role in the prevention and management of sarcopenia? Clin Nutr. 2018 Aug;37(4):1121-1132. doi: 10.1016/j.clnu.2017.08.016. Epub 2017 Aug 24.

  PMID: 28927897 BACKGROUND

• Smolen JS, Landewe RBM, Bergstra SA, Kerschbaumer A, Sepriano A, Aletaha D, Caporali R, Edwards CJ, Hyrich KL, Pope JE, de Souza S, Stamm TA, Takeuchi T, Verschueren P, Winthrop KL, Balsa A, Bathon JM, Buch MH, Burmester GR, Buttgereit F, Cardiel MH, Chatzidionysiou K, Codreanu C, Cutolo M, den Broeder AA, El Aoufy K, Finckh A, Fonseca JE, Gottenberg JE, Haavardsholm EA, Iagnocco A, Lauper K, Li Z, McInnes IB, Mysler EF, Nash P, Poor G, Ristic GG, Rivellese F, Rubbert-Roth A, Schulze-Koops H, Stoilov N, Strangfeld A, van der Helm-van Mil A, van Duuren E, Vliet Vlieland TPM, Westhovens R, van der Heijde D. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023 Jan;82(1):3-18. doi: 10.1136/ard-2022-223356. Epub 2022 Nov 10.

  PMID: 36357155 BACKGROUND

• Bennett JL, Pratt AG, Dodds R, Sayer AA, Isaacs JD. Rheumatoid sarcopenia: loss of skeletal muscle strength and mass in rheumatoid arthritis. Nat Rev Rheumatol. 2023 Apr;19(4):239-251. doi: 10.1038/s41584-023-00921-9. Epub 2023 Feb 17.

  PMID: 36801919 BACKGROUND

• Li TH, Chang YS, Liu CW, Su CF, Tsai HC, Tsao YP, Liao HT, Chen MH, Chuang CC, Yang YY, Tsai CY. The prevalence and risk factors of sarcopenia in rheumatoid arthritis patients: A systematic review and meta-regression analysis. Semin Arthritis Rheum. 2021 Feb;51(1):236-245. doi: 10.1016/j.semarthrit.2020.10.002. Epub 2020 Dec 17.

  PMID: 33385864 BACKGROUND

• Santilli V, Bernetti A, Mangone M, Paoloni M. Clinical definition of sarcopenia. Clin Cases Miner Bone Metab. 2014 Sep;11(3):177-80.

  PMID: 25568649 BACKGROUND

• Sambrook PN. The skeleton in rheumatoid arthritis: common mechanisms for bone erosion and osteoporosis? J Rheumatol. 2000 Nov;27(11):2541-2. No abstract available.

  PMID: 11093430 BACKGROUND

• Delmonico MJ, Harris TB, Lee JS, Visser M, Nevitt M, Kritchevsky SB, Tylavsky FA, Newman AB; Health, Aging and Body Composition Study. Alternative definitions of sarcopenia, lower extremity performance, and functional impairment with aging in older men and women. J Am Geriatr Soc. 2007 May;55(5):769-74. doi: 10.1111/j.1532-5415.2007.01140.x.

  PMID: 17493199 BACKGROUND

• Malaviya AN, Kapoor SK, Singh RR, Kumar A, Pande I. Prevalence of rheumatoid arthritis in the adult Indian population. Rheumatol Int. 1993;13(4):131-4. doi: 10.1007/BF00301258.

  PMID: 8310203 BACKGROUND

• GBD 2021 Rheumatoid Arthritis Collaborators. Global, regional, and national burden of rheumatoid arthritis, 1990-2020, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Sep 25;5(10):e594-e610. doi: 10.1016/S2665-9913(23)00211-4. eCollection 2023 Oct.

  PMID: 37795020 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Manmeet Singh, MBBS

  Satguru Partal Singh Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 30, 2026
• Study Start: April 1, 2024
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 21-07-2026 to 20-07-2031
• Access Criteria: Public via OSF under CC BY 4.0; citation required.

Locations

IN (1)