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

Category Primary study
Registry of TrialsISRCTN registry
Year 2024
INTERVENTION: As this is a randomized controlled trial, a computerised software will be used to randomize the participants. Group allocation of participants will be based on gender and ethnicity by block randomisation method using an online randomiser. Participants in the intervention group will be administered with an oral nutrition supplementation enriched with HMB and UC‐II® and exercise training, whereas participants in the control group will receive routine care and exercise training. Both groups will receive the same exercise training routines. The oral nutrition supplementation enriched with HMB and UC‐II® used in the intervention group of this study is a complete nutrition sponsored by Powerlife (M) Sdn. Bhd. The name of the intervention product is known as Metabolic + Energold. As per dietitian's recommendation, participants in the intervention group will be asked to consume two servings of Metabolic + Energold daily, with each serving containing 60 g of Metabolic + Energold powder in sachet form and it is to be diluted in 200 ml of room temperature water. By taking two servings of the oral nutrition supplement daily, each participant will be getting 518 kcal and 20.8 g of protein. All participants from both the intervention group and control group will receive home‐based exercise programmes by trained physiotherapists. An exercise manual with pictorial representations and written descriptions of each exercise will be given. All participants are encouraged to perform the exercise programmes three times per week (approximately 30 minutes each time) for 12 weeks. All participants are required to attend the monthly follow‐up for 12 weeks. Depending on the outcomes of the individual assessments by the physiotherapist at each visit, the selection of exercises and the appr CONDITION: Knee osteoarthritis ; Musculoskeletal Diseases PRIMARY OUTCOME: 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 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 SECONDARY OUTCOME: 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 using Control, Autonomy, Self‐realisation and Pleasure questionnaire (CASP‐12) at baseline, week 6, week 12 and week 24; 5. Diet intake assessed using a dietary history questionnaire (DHQ) at baseline, week 6, week 12 and week 24; 6. Morphological changes of knee determined using magnetic resonance imaging (MRI) at baseline, week 12 and week 24; 7. Instrumental activities of daily living (IADL) measured using an IADL questionnaire at baseline; 8. Nutritional status assessed using Patient‐Generated Subjective Global Assessment (PG‐SGA) at baseline; 9. Disability assessed using the World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0) questionnaire at baseline, week 6, week 12 and week 24; 10. Psychological status evaluated using depression, anxiety and stress scale (DASS21) at baseline, week 6, week 12 and week 24; 11. Metabolic gene expression profile and pathway analysis analysed using Blood/Cell RNA Mini Kit with DNase (Geneaid) at baseline, week 12 and week 24
Epistemonikos ID: 9fa99ffa3b4de34a7b04f76ba4075007d9bb257d
First added on: Aug 28, 2024