A study protocol to investigate if acipimox improves muscle function and sarcopenia: an open-label, uncontrolled, before-and-after experimental medicine feasibility study in community-dwelling older adults

Introduction
Sarcopenia is the age-associated loss of muscle mass and strength. Nicotinamide adenine dinucleotide (NAD) plays a central role in both mitochondrial function and cellular ageing processes implicated in sarcopenia. NAD concentrations are low in older people with sarcopenia, and increasing skeletal muscle NAD concentrations may offer a novel therapy for this condition. Acipimox is a licensed lipid-lowering agent known to act as an NAD precursor. This open-label, uncontrolled, before-and-after proof-of-concept experimental medicine study will test whether daily supplementation with acipimox improves skeletal muscle NAD concentrations.

Methods and analysis
Sixteen participants aged 65 and over with probable sarcopenia will receive acipimox 250 mg and aspirin 75 mg orally daily for 4 weeks, with the frequency of acipimox administration being dependent on renal function. Muscle biopsy of the vastus lateralis and MRI scanning of the lower leg will be performed at baseline before starting acipimox and after 3 weeks of treatment. Adverse events will be recorded for the duration of the trial. The primary outcome, analysed in a per-protocol population, is the change in skeletal muscle NAD concentration between baseline and follow-up. Secondary outcomes include changes in phosphocreatine recovery rate by 31P magnetic resonance spectroscopy, changes in physical performance and daily activity (handgrip strength, 4 m walk and 7-day accelerometry), changes in skeletal muscle mitochondrial respiratory function, changes in skeletal muscle mitochondrial DNA copy number and changes in NAD concentrations in whole blood as a putative biomarker for future participant selection.

Ethics and dissemination
The trial is approved by the UK Medicines and Healthcare Products Regulatory Agency (EuDRACT 2021-000993-28) and UK Health Research Authority and Northeast – Tyne and Wear South Research Ethics Committee (IRAS 293565). Results will be made available to participants, their families, patients with sarcopenia, the public, regional and national clinical teams, and the international scientific community.

Protocol
Acipimox feasibility study Clinical Trial Protocol V.2 2/11/21.

Trial registration number
The ISRCTN trial database (ISRCTN87404878).

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Febbraio 2024

Association between sarcopenia grade and fall history among older adults in West China: A retrospective study

Objectives
The association between sarcopenia severity and fall history remains under-researched at present. Accordingly, this study was developed to evaluate the relationship between sarcopenic status and prior fall events in a multiethnic group of older community-dwelling adults in Western China.

Design
A retrospective survey study, the data comes from the West China Health and Aging Trend study.

Setting
The study was based in Western China.

Participants
In total, this retrospective analysis incorporated data from 2719 older adults (59.2% women).

Primary and secondary outcome measures
Grip strength, gait speed and skeletal muscle mass index values were analysed for all participants, and the Asian Working Group for Sarcopenia (AWGS) 2014 and 2019 consensus criteria were leveraged to assess sarcopenia status in these individuals. Prior fall history was defined by any incidents in which an individual unintentionally came to rest on the floor within the past year. The association between sarcopenia status and fall history was examined through a binary logistic regression approach, with p

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Febbraio 2024