Effectiveness and sustainability of an oral nutrition supplementation enriched with HMB and UC-II® combined with exercise training in older adults with knee osteoarthritis

Not Applicable

• Conditions: Knee osteoarthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN14284561
• Lead Sponsor: Powerlife (M) Sdn. Bhd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-17
• Last Update Posted: 8 July 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 80

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2. Pain intensity measured using the visual analogue scale (VAS) at baseline, week 6, week 12 and week 24<br>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