Knee osteoarthritis Musculoskeletal Diseases
Conditions
Interventions
Current interventions as of 22/11/2024:
There will be two interventional groups in this study, which are the study group receiving the oral nutritional supplementation combined with exercise trainin
Sponsors
Powerlife (M) Sdn. Bhd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Malaysians aged >=50 years old with at least mild osteoarthritis as diagnosed by a physician or clinical radiologist and do not suffer from diseases as mentioned in the exclusion criteria (see participant exclusion criteria) 2. Able to communicate in Malay or English language 3. Able to eat and drink safely without modified texture diets
Exclusion criteria
Exclusion criteria: 1. Receiving enteral tube feeding (ETF), parenteral nutrition or consuming ONS (or those who had consumed ONS in the past 4 weeks prior to the study) 2. Institutionalised older adults, bedridden or having severe health problems 3. Suffering from chronic kidney disease, dementia, liver failure, malignancy, gastrointestinal diseases, thyroid disorders, palliative care for terminal disease, stroke 4. Suffering from other type of arthritis; rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, post-meniscectomy OA, femoro-patellar OA, Genuvarum/valgum 5. Suffering from major psychiatric illness 6. Consuming medications that could affect muscle mass and/or function (e.g., HMG-CoA reductase inhibitors, steroids) within 1 year before enrolling in the study 7. Physical disabilities (unable to walk even with a walking aid) 8. Currently participating in other clinical trials 9. Participants with claustrophobia (for participants selected to undergo MRI) 10. Participants with metallic implants, such as prostheses, shrapnel or aneurysm clips, or electric implants, such as cardiac pacemakers (for participants selected to undergo MRI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 22/11/2024: 1. OA-related symptoms (or the severity of OA symptoms) measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, week 6 and week 12 2. Inflammatory biomarkers (osteoarthritis-related biomarkers) such as cytokines (interleukin-1ß), tumour necrosis factor-a (TNF-a), tumour growth factor-ß (TGF-ß), matrix metalloproteinase-13 (MMP-13), C-telopeptide of crosslinked collagen type I and type II (CTX-I and CTX-II), and osteocalcin measured using conventional ELISA assay of blood serum at baseline and week 12 _____ Previous primary outcome measure: 1. OA-related symptoms (or the severity of OA symptoms) measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, week 6, week 12 and week 24 2. Pain intensity measured using the visual analogue scale (VAS) at baseline, week 6, week 12 and week 24 3. Inflammatory biomarkers (osteoarthritis-related biomarkers) such as cytokines (interleukin-1ß), tumour necrosis factor-a (TNF-a), radical oxygen species, advanced glycation end products (AGEs) and prostaglandins measured using multiplex ELISA assay of blood serum at baseline, week 12 and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/11/2024: 1. Body composition measured using bioelectric impedance analyzer (InBody 270) at baseline, week 6 and week 12 2. Blood profiles such as full blood count, blood sugar profile, lipid profile, liver function test and renal profile analysed at the medical laboratory (Innoquest Pathology Sdn. Bhd.) at baseline and week 12 3. Physical fitness assessed using the Functional Fitness MOT (FFMOT) and International Physical Activity Questionnaire (IPAQ) at baseline, week 6 and week 12 4. Quality of life measured using Control, Autonomy, Self-realisation and Pleasure questionnaire (CASP-12) at baseline, week 6 and week 12 5. Diet intake assessed using a dietary history questionnaire (DHQ) at baseline, week 6 and week 12 6. Morphological changes of knee determined using magnetic resonance imaging (MRI) at baseline and week 12 7. Nutritional status assessed using Patient-Generated Subjective Global Assessment (PG-SGA) at baseline, week 6 and week 12 8. Disability assessed using the World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0) questionnaire at baseline, week 6 and week 12 9. Psychological status evaluated using the Depression, Anxiety and Stress Scale (DASS21) at baseline, week 6 and week 12 10. Gene expression profile analysed using qPCR from total RNA extracted using Blood/Cell RNA Mini Kit with DNase (Geneaid) at baseline and week 12 _____ Previous secondary outcome measures: 1. Body composition measured using bioelectric impedance analyzer (InBody 270) at baseline, week 6, week 12 and week 24 2. Blood profiles such as full blood count, blood sugar profile, lipid profile, liver function test and renal profile analysed at the medical laboratory (Pathlab Malaysia Sdn. Bhd.) at baseline and week 12 3. Physical fitness measured using the Senior Fitness test (modified-SFT) and International Physical Activity Questionnaire (IPAQ) at baseline, week 6, week 12 and week 24 4. Quality of life measured | — |
Countries
Malaysia
Contacts
Public ContactAnastasia Xin Wei Yap
Outcome results
None listed