Rheumatoid ArthritisNCT06400316
Muscle Wasting and Rheumatoid Arthritis Flares
A study testing Amino Acid Supplement in people with Rheumatoid Arthritis and Muscle Atrophy, run by Leeds Beckett University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis, Muscle Atrophy
- What is being tested?
- Amino Acid Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 13 May 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of a flare of rheumatoid arthritis
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Preventing Muscle Wasting During Rheumatoid Arthritis Flares: A Randomised Controlled Trial
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.
Read more
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.
Read the detailed description
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.
RA is the most common inflammatory arthritis manifesting mainly as joint swelling and pain, limiting mobility, and eventually leading to loss of functional capacity. RA also has severe extra-articular manifestations [1], affecting several tissues in the body including skeletal muscle [2]. People living with RA often present with an adverse body composition profile compared to the general population, characterised by low muscle mass at the presence of unchanged or even increased overall weight [3]. This condition, termed Rheumatoid Cachexia, may affect up to 2 out of 3 people with RA and associates with active disease, further reductions in mobility, and low quality of life [4].
While rheumatoid cachexia has been studied extensively, the course of its development, as well as potential causes or contributors to it are poorly understood. Inflammation, [5] as well as lifestyle factors, such as energy intake and physical activity, may contribute to the observed body composition changes [6].
People living with RA often experience flares of disease activity, where high levels of inflammation, cause an acute exaggeration of symptoms, leading to very low levels of mobility. This is commonly treated with corticosteroid injections which will rapidly reduce inflammation and allow the patient to regain mobility. However, that short period of high inflammatory load and low mobility may acutely affect muscle characteristics. Indeed, critically ill patients may lose up to 2% of skeletal muscle per day during the first week of hospitalisation [7]. This rapid decline in muscle health has been recently termed Acute sarcopenia (AS) by the European working group in sarcopenia and older persons (EWGSOP) [8]. Furthermore, recent work within this research team is currently under review (Aldrich et al., 2023 under review) demonstrating the rapid decline of muscle mass and quality in people suffering with various diseases. Additionally, corticosteroids themselves may further contribute to muscle wasting in RA [9]. Yet, the acute effects of flares and their treatment on muscle health in people with RA are not known.
Acute deterioration of muscle health following a flare may point towards a stepwise development of rheumatoid cachexia, i.e., bouts of acute deterioration that accumulate over time in steps rather than a continuous slow loss - which is the current understanding for the development of sarcopenia, the age-related muscle wasting. This would allow for target and potentially short-term interventions that could limit or even reverse muscle deterioration during a flare and help people with RA better maintain their functionality.
Exercise, and particularly resistance exercise, is the most effective way to increase muscle mass, strength, and quality. However, people during and shortly after a flare may not be willing to engage in such an intervention. Additional complexities around gym or home-based delivery, familiarisation, and safe execution render this a complex intervention with potentially limited applicability.
Nutritional supplementation on the other hand, is readily available, relatively cheap, and easy to administer. Specifically, for muscle health, amino acid supplementation, and particularly with leucine, has been shown to improve muscle mass and muscle function in older men and women [10]. Moreover, previous research has shown that these amino acid supplements do not suppress appetite, are well tolerated and easy to consume. Finally, recent unpublished data from this laboratory suggest that amino acid concentrations in the blood following consumption alongside a meal remain elevated vs placebo for over 2 hours. This indicates that consuming two supplements per day would provide sufficient amino acids to induce beneficial effects on muscle health.
Therefore, the aims of this investigation are:
- To understand the effects of acute RA flares on muscle health
- To assess the efficacy of amino acid supplementation vs. standard care in maintaining muscle health
- Conditions
- Rheumatoid Arthritis, Muscle Atrophy
- Being tested
- Amino Acid Supplement
- Keywords
- Rheumatoid Arthritis, Muscle Atrophy
- Medical subject headings
- Arthritis, Rheumatoid, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid SupplementDietary supplement
Also called Amino Acid Gel
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Amino Acid Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Quadriceps lean tissue mass will be assessed by dual energy x-ray absorptiometry scans focussed in the quadriceps region. Lean tissue mass in this region will be provided in kilograms.
Measured: Scans will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Rectus Femoris Cross-sectional Area
Rectus femoris will be assessed by ultrasound scans. The muscle belly will be imaged and cross-sectional area will be calculated from this image (cm2).
Measured: Scans will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Handgrip Strength
Upper-body muscle strength will be assessed by handgrip dynamometry and the value will be recorded in kilograms.
Measured: Strength tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Knee Extensor Strength
Lower-body muscle strength will be assessed on a seated knee extension resistance machine and the highest value achieved will be recorded in kilograms.
Measured: 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 will be assessed by the Short Physical Performance Battery. This battery includes measures of gait speed, lower-limb strength/functionality and balance. The score of all tests is combined to provide a total score where a higher score indicates better muscle function.
Measured: Muscle function tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Timed Up and Go
Muscle function will be assessed by the Timed Up and Go Test. This test assesses mobility and balance. The time taken to complete standing, walking 3-metres, then returning to sit down is recorded and a shorter time indicates better functionality.
Measured: Muscle function tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
6-minute Walk Test
Muscle function will be assessed by the 6-Minute Walk Test. This test assesses endurance and aerobic capacity. The total distance walked in 6 minutes is recorded and a higher score indicates greater aerobic capacity.
Measured: Muscle function tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Plasma Amino Acid Content
Blood plasma amino acid content (μmol/L) will be assessed at all time points using liquid chromatography mass spectrometry.
Measured: Blood tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Serum Steroid Hormone Content
Blood serum steroid hormone content (ng/ml) will be assessed at all time-points using liquid chromatography mass spectrometry.
Measured: Blood tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Serum Vitamin D Content
Blood serum vitamin D content (ng/ml)will be assessed at all time-points using liquid chromatography mass spectrometry.
Measured: Blood tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Diet Recall
Participants will be asked to recall their dietary intake over the preceding 24 hours to determine calorie intake.
Measured: 24-hour diet recall tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Physical Activity
Physical activity habits will be assessed using the International Physical Activity Questionnaire (IPAQ) (short version). Time spent sitting, walking and exercising at various intensities will be recorded in days and hours.
Measured: 24-hour diet recall tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Physical Ability, Social Support and Interaction, Pain, Health & Mood (Quality of Life - Rheumatoid Arthritis-Specific)
Quality of life will be assessed using the established Rheumatoid Arthritis quality of life (RAQoL) questionnaire. This will be assessed from a series of questions which will require answers ranked from 1 (very poor) to excellent (10).
Measured: Quality of life assessments will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Interaction & Pain (Quality of Life - PROMIS-29)
Quality of life will be assessed using the Patient Reported Outcome Measures Information System (PROMIS-29) questionnaire. This will assess physical function, anxiety, depression, fatigue, sleep disturbance, ability to take part in social roles and activities, pain interference and pain intensity. All answers will be on a scale from 1 to 5 except for pain intensity which is recorded on a scale from 1 to 10. Lower scores indicate negative answers except for questions regarding physical function and pain intensity.
Measured: Quality of life assessments will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start13 May 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leeds Beckett University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theocharis Ispoglou, PhD, Study chair, Leeds Beckett UniversityOliver Wilson, PhD, Study chair, Leeds Beckett University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400316
- Sponsor's protocol ID
- 335887
- Status last verified
- May 2024
- First submitted
- 4 Jan 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be anonymised and kept within the current research group. Participant data will not be shared with other researchers.
Publications
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.
PubMed 37496102Farrow 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.
PubMed 32910153Stavropoulos-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.
PubMed 17289757Efthymiou 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.
PubMed 36531417Ollewagen 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.
PubMed 34806343Masuko 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.
PubMed 25988122Fazzini 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.
PubMed 36597123Cruz-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.
PubMed 30312372Lemmey 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.
PubMed 30071930Ispoglou 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.
PubMed 26081485
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Muscle Wasting During Rheumatoid Arthritis Flares: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06400316
- Acronym / sponsor ID
- 335887
- Conditions
- Rheumatoid Arthritis, Muscle Atrophy
- Keywords
- Rheumatoid Arthritis, Muscle Atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Leeds Beckett UniversityUniversity, hospital or other
- Study start
- 13 May 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
RA is the most common inflammatory arthritis manifesting mainly as joint swelling and pain, limiting mobility, and eventually leading to loss of functional capacity. RA also has severe extra-articular manifestations [1], affecting several tissues in the body including skeletal muscle [2]. People living with RA often present with an adverse body composition profile compared to the general population, characterised by low muscle mass at the presence of unchanged or even increased overall weight [3]. This condition, termed Rheumatoid Cachexia, may affect up to 2 out of 3 people with RA and associates with active disease, further reductions in mobility, and low quality of life [4].
While rheumatoid cachexia has been studied extensively, the course of its development, as well as potential causes or contributors to it are poorly understood. Inflammation, [5] as well as lifestyle factors, such as energy intake and physical activity, may contribute to the observed body composition changes [6].
People living with RA often experience flares of disease activity, where high levels of inflammation, cause an acute exaggeration of symptoms, leading to very low levels of mobility. This is commonly treated with corticosteroid injections which will rapidly reduce inflammation and allow the patient to regain mobility. However, that short period of high inflammatory load and low mobility may acutely affect muscle characteristics. Indeed, critically ill patients may lose up to 2% of skeletal muscle per day during the first week of hospitalisation [7]. This rapid decline in muscle health has been recently termed Acute sarcopenia (AS) by the European working group in sarcopenia and older persons (EWGSOP) [8]. Furthermore, recent work within this research team is currently under review (Aldrich et al., 2023 under review) demonstrating the rapid decline of muscle mass and quality in people suffering with various diseases. Additionally, corticosteroids themselves may further contribute to muscle wasting in RA [9]. Yet, the acute effects of flares and their treatment on muscle health in people with RA are not known.
Acute deterioration of muscle health following a flare may point towards a stepwise development of rheumatoid cachexia, i.e., bouts of acute deterioration that accumulate over time in steps rather than a continuous slow loss - which is the current understanding for the development of sarcopenia, the age-related muscle wasting. This would allow for target and potentially short-term interventions that could limit or even reverse muscle deterioration during a flare and help people with RA better maintain their functionality.
Exercise, and particularly resistance exercise, is the most effective way to increase muscle mass, strength, and quality. However, people during and shortly after a flare may not be willing to engage in such an intervention. Additional complexities around gym or home-based delivery, familiarisation, and safe execution render this a complex intervention with potentially limited applicability.
Nutritional supplementation on the other hand, is readily available, relatively cheap, and easy to administer. Specifically, for muscle health, amino acid supplementation, and particularly with leucine, has been shown to improve muscle mass and muscle function in older men and women [10]. Moreover, previous research has shown that these amino acid supplements do not suppress appetite, are well tolerated and easy to consume. Finally, recent unpublished data from this laboratory suggest that amino acid concentrations in the blood following consumption alongside a meal remain elevated vs placebo for over 2 hours. This indicates that consuming two supplements per day would provide sufficient amino acids to induce beneficial effects on muscle health.
Therefore, the aims of this investigation are:
- To understand the effects of acute RA flares on muscle health
- To assess the efficacy of amino acid supplementation vs. standard care in maintaining muscle health
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –This 'control' group will receive standard care following a flare of rheumatoid arthritis. |
| Nutritional Supplementation | Experimental | Dietary Supplement: Amino Acid SupplementThis 'intervention' group will receive a 4-week intervention involving twice daily consumption of amino acid supplements. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of a flare of rheumatoid arthritis
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amino Acid SupplementAlso: Amino Acid GelThe 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. | Dietary supplement | Nutritional Supplementation |
Primary outcome
Lean Tissue Mass
Time frame: Scans will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
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.
14 secondary outcomes
Quadriceps Lean Tissue Mass
Time frame: Scans will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Rectus Femoris Cross-sectional Area
Time frame: Scans will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Handgrip Strength
Time frame: Strength tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Knee Extensor Strength
Time frame: Strength tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Short Physical Performance Battery
Time frame: Muscle function tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Timed Up and Go
Time frame: Muscle function tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
6-minute Walk Test
Time frame: Muscle function tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Plasma Amino Acid Content
Time frame: Blood tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Serum Steroid Hormone Content
Time frame: Blood tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Serum Vitamin D Content
Time frame: Blood tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Diet Recall
Time frame: 24-hour diet recall tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Physical Activity
Time frame: 24-hour diet recall tests will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Physical Ability, Social Support and Interaction, Pain, Health & Mood (Quality of Life - Rheumatoid Arthritis-Specific)
Time frame: Quality of life assessments will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Interaction & Pain (Quality of Life - PROMIS-29)
Time frame: Quality of life assessments will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Background: PubMed 37496102Bonfiglioli 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.
- Background: PubMed 32910153Farrow 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.
- Background: PubMed 17289757Stavropoulos-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.
- Background: PubMed 36531417Efthymiou 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.
- Background: PubMed 34806343Ollewagen 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.
- Background: PubMed 25988122Masuko 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.
- Background: PubMed 36597123Fazzini 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.
- Background: PubMed 30312372Cruz-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.
- Background: PubMed 30071930Lemmey 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.
- Background: PubMed 26081485Ispoglou 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.
- Individual participant dataSharing planned: No. Participant data will be anonymised and kept within the current research group. Participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theocharis Ispoglou, PhD study chair
Leeds Beckett University
Oliver Wilson, PhD study chair
Leeds Beckett University
Questions about this trial
What is this clinical trial studying?
A study testing Amino Acid Supplement in people with Rheumatoid Arthritis and Muscle Atrophy, run by Leeds Beckett University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luke Aldrich, MSc (0113 812 5180 ext. +44, L.Aldrich@leedsbeckett.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean Tissue Mass (time frame: Scans will take place at baseline and 1-week, 2-weeks, 4-weeks and 12-weeks after baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06400316, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.