Impact of Optimised Protein Intake on Household Work Limitations and Disability in Rheumatoid Arthritis
27 juli 2026 bijgewerkt door: Satguru Partap Singh Hospitals
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
120
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Punjab
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Ludhiana, Punjab, Indië, 141003
- Satguru Partap Singh Hospitals
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Protein Optimisation Improves Household Work and Functional Status in RA
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.
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Household Work Limitations measured by Household Work Limitations Questionnaire (HOWL-Q)
Tijdsspanne: 12 weeks
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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.
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12 weeks
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Change in Overall Functional Disability measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)
Tijdsspanne: 12 weeks
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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.
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12 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Manmeet Singh, MBBS, Satguru Partal Singh Hospitals
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
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- 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.
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- 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.
- 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.
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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- 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.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 april 2024
Primaire voltooiing (Werkelijk)
15 september 2025
Studie voltooiing (Werkelijk)
15 september 2025
Studieregistratiedata
Eerst ingediend
21 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
27 juli 2026
Eerst geplaatst (Werkelijk)
30 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
30 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
27 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DMS/SPS-I/2024/96
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
De-identified participant-level data (PDF) with HAQ-DI, HOWL-Q, DAS28 category, protein intake, adherence.
IPD-tijdsbestek voor delen
21-07-2026 to 20-07-2031
IPD-toegangscriteria voor delen
Public via OSF under CC BY 4.0; citation required.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- MVO
Bestudeer gegevens/documenten
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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