Muscle Wasting and Rheumatoid Arthritis Flares

NCT06400316 | Not Yet Recruiting DMC

• 1 other identifier: 335887
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

People living with Rheumatoid Arthritis (RA) often present with low muscle mass compared to their healthy counterparts. This affects their mobility, overall health and quality of life. Even though low muscle mass in RA has been recognised for decades, it is still highly prevalent and very little is known about its development, progression, and potential management. The researchers hypothesise that flares of disease activity trigger acute events of muscle wasting due to high inflammation and reduced mobility. This is commonly observed in bed rest studies and people hospitalised for various reasons. If this holds true for RA, it would point towards a stepwise development of RC and potentially allow for time-targeted management of it. A potential method to manage it is through the use of nutritional supplements. Specifically, amino acid supplementation (commonly used by athletes or people wanting to increase muscle mass) during and shortly after a flare may counteract some of the muscle wasting and allow for better long-term mobility and quality of life for people living with RA. This study aims to investigate aspects of muscle health changes following a disease flare-up in people with Rheumatoid Arthritis (RA) and test potential interventions to minimise any such changes. The investigators will randomly assign participants to a standard care or a nutritional supplementation group and assess aspects of body composition, muscle health, disease activity and inflammation on five occasions over a 3-month period.

Conditions

Rheumatoid Arthritis; Muscle Atrophy

Keywords

Rheumatoid Arthritis; Muscle Atrophy

Outcome Measures

Primary Outcomes (1)

• Lean Tissue Mass

  Whole-body composition will be assessed by dual energy x-ray absorptiometry scans and this will provide a value for lean tissue (muscle mass) in kilograms.

  Scans will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.

Secondary Outcomes (14)

• Quadriceps Lean Tissue Mass

  Scans will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.

• Rectus Femoris Cross-sectional Area

  Scans will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.

• Handgrip Strength

  Strength tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.

• Knee Extensor Strength

  Strength tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.

• Short Physical Performance Battery

  Muscle function tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.

Study Arms (2)

Standard Care

NO INTERVENTION

This 'control' group will receive standard care following a flare of rheumatoid arthritis.

Nutritional Supplementation

EXPERIMENTAL

This 'intervention' group will receive a 4-week intervention involving twice daily consumption of amino acid supplements.

Dietary Supplement: Amino Acid Supplement

Interventions

Amino Acid Supplement DIETARY_SUPPLEMENT

The intervention lasts 4-week following the rheumatoid arthritis flare. It requires twice daily consumption of amino acid supplements alongside the breakfast and lunch time meals.

Also known as: Amino Acid Gel

Nutritional Supplementation

Eligibility Criteria

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

You may qualify if:

• Diagnosis of a flare of rheumatoid arthritis

You may not qualify if:

• Consultation with RA physician greater than 7 days before
• Allergic to supplement ingredients
• Other health conditions that affect muscle wasting; such as cancer and fibromyalgia
• Previous joint replacement surgery within the last 6 months
• Anyone with underlying kidney conditions
• Currently partaking in other research projects involving treatments, exercise or nutritional interventions for rheumatoid arthritis
• Patients who may be pregnant
• Patients who are unable to provide their own informed consent
• Patients who are unable to speak or understand English
• Participants who have a diagnosis of dementia or Alzheimer's disease
• Disabled participants who require wheelchair access

Sponsors & Collaborators

• Leeds Beckett University: lead

Related Publications (10)

• Bonfiglioli KR, de Medeiros Ribeiro AC, Carnieletto AP, Pereira I, Domiciano DS, da Silva HC, Pugliesi A, Pereira LR, Guimaraes MFR, Giorgi RDN, Reis APMG, Brenol CV, Louzada-Junior P, da Cunha Sauma MFL, Radominski SC, da Mota LMH, da Rocha Castelar-Pinheiro G. Extra-articular manifestations of rheumatoid arthritis remain a major challenge: data from a large, multi-centric cohort. Adv Rheumatol. 2023 Jul 26;63(1):34. doi: 10.1186/s42358-023-00318-y.

  PMID: 37496102 BACKGROUND

• Farrow M, Biglands J, Tanner S, Hensor EMA, Buch MH, Emery P, Tan AL. Muscle deterioration due to rheumatoid arthritis: assessment by quantitative MRI and strength testing. Rheumatology (Oxford). 2021 Mar 2;60(3):1216-1225. doi: 10.1093/rheumatology/keaa364.

  PMID: 32910153 BACKGROUND

• Stavropoulos-Kalinoglou A, Metsios GS, Koutedakis Y, Nevill AM, Douglas KM, Jamurtas A, van Zanten JJ, Labib M, Kitas GD. Redefining overweight and obesity in rheumatoid arthritis patients. Ann Rheum Dis. 2007 Oct;66(10):1316-21. doi: 10.1136/ard.2006.060319. Epub 2007 Feb 8.

  PMID: 17289757 BACKGROUND

• Efthymiou E, Grammatikopoulou MG, Gkiouras K, Efthymiou G, Zafiriou E, Goulis DG, Sakkas LI, Bogdanos DP. Time to Deal with Rheumatoid Cachexia: Prevalence, Diagnostic Criteria, Treatment Effects and Evidence for Management. Mediterr J Rheumatol. 2022 Sep 30;33(3):271-290. doi: 10.31138/mjr.33.3.271. eCollection 2022 Sep.

  PMID: 36531417 BACKGROUND

• Ollewagen T, Powrie YSL, Myburgh KH, Smith C. Unresolved intramuscular inflammation, not diminished skeletal muscle regenerative capacity, is at the root of rheumatoid cachexia: insights from a rat CIA model. Physiol Rep. 2021 Nov;9(22):e15119. doi: 10.14814/phy2.15119.

  PMID: 34806343 BACKGROUND

• Masuko K. Rheumatoid cachexia revisited: a metabolic co-morbidity in rheumatoid arthritis. Front Nutr. 2014 Nov 24;1:20. doi: 10.3389/fnut.2014.00020. eCollection 2014.

  PMID: 25988122 BACKGROUND

• Fazzini B, Markl T, Costas C, Blobner M, Schaller SJ, Prowle J, Puthucheary Z, Wackerhage H. The rate and assessment of muscle wasting during critical illness: a systematic review and meta-analysis. Crit Care. 2023 Jan 3;27(1):2. doi: 10.1186/s13054-022-04253-0.

  PMID: 36597123 BACKGROUND

• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

  PMID: 30312372 BACKGROUND

• Lemmey AB, Wilkinson TJ, Perkins CM, Nixon LA, Sheikh F, Jones JG, Ahmad YA, O'brien TD. Muscle loss following a single high-dose intramuscular injection of corticosteroids to treat disease flare in patients with rheumatoid arthritis. Eur J Rheumatol. 2018 Sep;5(3):160-164. doi: 10.5152/eurjrheum.2018.17148. Epub 2018 Apr 2.

  PMID: 30071930 BACKGROUND

• Ispoglou T, White H, Preston T, McElhone S, McKenna J, Hind K. Double-blind, placebo-controlled pilot trial of L-Leucine-enriched amino-acid mixtures on body composition and physical performance in men and women aged 65-75 years. Eur J Clin Nutr. 2016 Feb;70(2):182-8. doi: 10.1038/ejcn.2015.91. Epub 2015 Jun 17.

  PMID: 26081485 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Muscular Atrophy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Theocharis Ispoglou, PhD

  Leeds Beckett University

  STUDY CHAIR

• Oliver Wilson, PhD

  Leeds Beckett University

  STUDY CHAIR

Central Study Contacts

Luke Aldrich, MSc

CONTACT

0113 812 5180; L.Aldrich@leedsbeckett.ac.uk

Antonis Stavropoulos-Kalinoglou, PhD

CONTACT

01138124298; a.stavropoulos@leedsbeckett.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One control group will receive standard care following diagnosis of a flare of rheumatoid arthritis. The parallel group will receive a 4-week intervention involving two daily amino acid supplements.

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: May 6, 2024
• Study Start: May 13, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share