Omega-3 polyunsaturated fatty acid supplementation for muscle health in community-dwelling older adults at high risk of sarcopenia: protocol for a multicentre, randomised, double-blind, placebo-controlled trial
Abstract
Introduction: Sarcopenia imposes a substantial burden on society, while omega-3 polyunsaturated fatty acid (n-3 PUFA) supplementation holds the potential for preventing and treating this condition. This study aims to investigate the efficacy of three different n-3 PUFA supplementation regimens compared with each other and to corn oil placebo intervention on muscle health in community-dwelling older adults at high risk of sarcopenia.
Methods and analysis: A total of 400 community-dwelling older adults aged 60 years or older, with handgrip strength <28 kg (men) or <18 kg (women), will be recruited for this multicentre, randomised, double-blind, placebo-controlled trial. Participants will be randomly allocated (1:1:1:1) to one of four groups for 6 months: (1) the high eicosapentaenoic acid (EPA) group, (2) the high docosahexaenoic acid (DHA) group, (3) the high sn2-DHA group, (4) the corn oil control group. All intervention products will be packaged as capsules and administered at a daily dose of 2.5 g. The primary outcome is the change in handgrip strength. Secondary outcomes include changes in skeletal muscle mass, physical function, inflammation- and metabolism-related blood biomarkers and gut microbiota diversity.
A ethics and dissemination: This study was approved by the Ruijin Hospital Ethics Committee. Trial findings will be disseminated via publications in international peer-reviewed journals and presentations at relevant academic conferences. Study results will be made…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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