Impact of Optimised Protein Intake on Household Work Limitations and Disability in Rheumatoid Arthritis
27. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
120
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Punjab
-
Ludhiana, Punjab, Indie, 141003
- Satguru Partap Singh Hospitals
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Household Work Limitations measured by Household Work Limitations Questionnaire (HOWL-Q)
Časové okno: 12 weeks
|
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)
Časové okno: 12 weeks
|
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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Manmeet Singh, MBBS, Satguru Partal Singh Hospitals
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Santilli V, Bernetti A, Mangone M, Paoloni M. Clinical definition of sarcopenia. Clin Cases Miner Bone Metab. 2014 Sep;11(3):177-80.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Schiaffino S, Reggiani C. Fiber types in mammalian skeletal muscles. Physiol Rev. 2011 Oct;91(4):1447-531. doi: 10.1152/physrev.00031.2010.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. dubna 2024
Primární dokončení (Aktuální)
15. září 2025
Dokončení studie (Aktuální)
15. září 2025
Termíny zápisu do studia
První předloženo
21. července 2026
První předloženo, které splnilo kritéria kontroly kvality
27. července 2026
První zveřejněno (Aktuální)
30. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
30. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
27. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- DMS/SPS-I/2024/96
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
De-identified participant-level data (PDF) with HAQ-DI, HOWL-Q, DAS28 category, protein intake, adherence.
Časový rámec sdílení IPD
21-07-2026 to 20-07-2031
Kritéria přístupu pro sdílení IPD
Public via OSF under CC BY 4.0; citation required.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Studijní data/dokumenty
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .