Efficacy of oral nutrition supplementation enriched with hydroxymethylbutyrate (HMB) and undenatured type-II collagen (UC-II) combined with exercise training on osteoarthritis-related outcomes among adults with knee osteoarthritis in Klang Valley of Malaysia: study protocol for a randomised controlled trial

Abstract

Introduction: Knee osteoarthritis (OA) is a serious public health problem since it is linked to loss of muscular function and independence, especially in older adults. In this study, the researchers have proposed a randomised controlled trial with a three-arm study strategy to explore the effectiveness of an oral nutritional supplementation containing hydroxymethylbutyrate and undenatured type-II collagen combined with exercise training (ET) on the OA-related symptoms and biomarkers among adults with knee OA.

Methods and analysis: Adults with knee OA aged between 50 years and 75 years will be invited to participate in the study and thereafter will be randomly assigned to either one of three groups: oral nutrition supplementation+ET, ET or usual care. The primary outcomes include changes in OA-related symptoms and biomarkers. The secondary outcomes include changes in body composition, blood profiles, physical fitness, quality of life, dietary intake, disability, psychology status and morphological changes of the knee.

Ethics and dissemination: Ethics approval was granted by the Medical Research Ethics Committee of the National University of Malaysia (reference number JEP-2024-264). Findings of this study will be disseminated via peer-reviewed presentations at scientific conferences as well as open access publications.

Trial registration number: ISRCTN14284561.

Keywords: Clinical Trial; Exercise; Health; Knee; Magnetic Resonance Imaging; NUTRITION & DIETETICS.

Figure 1. Study flow chart. ET, exercise training; ONS, oral nutrition supplementation; UC, usual care.