Impacts of High-Protein Oral Nutritional Supplements Among Malnourished Men and Women with Sarcopenia: A Multicenter, Randomized, Double-Blinded, Controlled Trial

Joel T. Cramer, Alfonso J. Cruz-Jentoft, Francesco Landi, Mary Hickson, Mauro Zamboni, Suzette L. Pereira, Deborah S. Hustead, Vikkie A. Mustad

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108 Scopus citations


Background Recent evidence suggests that nutritional interventions may improve muscle outcomes in malnutrition and sarcopenia. Objectives We evaluated the effects of 2 high-quality oral nutritional supplements (ONS) differing in amount and type of key nutrients in older adult men and women. Design A multicenter, randomized, double-blinded, controlled clinical trial. Participants Malnourished and sarcopenic men and women, 65 years and older (n = 330). Intervention A 24-week intervention period with 2 energy-rich (330 kcal) ONS treatment groups: Control ONS (CONS, 14 g protein; 147 IU vitamin D3) versus Experimental ONS (EONS, 20 g protein; 499 IU vitamin D3; 1.5 g CaHMB) taken twice daily. Both ONS also contained other vitamins, minerals, and nutrients in varying amounts. Measurements Isokinetic peak torque (PT, Nm) leg strength, grip strength (kg), and gait speed (m·s−1) were assessed at baseline and 12 and 24 weeks. Left and right leg muscle mass (LMM, kg) were assessed by dual-energy x-ray absorptiometry (DXA). Muscle quality (MQ) was leg strength expressed relative to the tested LMM (Nm·kg−1). Subgroup analyses were performed: severe sarcopenia (low skeletal mass index, low grip strength [<30 kg men; <20 kg women], low gait speed [<0.8 m·s−1]) and mild-moderate sarcopenia (low skeletal mass index, normal gait speed, or normal grip strength). Results Both ONS groups (EONS and CONS) improved PT, MQ, grip strength, and gait speed from baseline with no treatment differences. Those with severe sarcopenia (44%) exhibited lower baseline PT and MQ, with no differences in strength improvements between treatments. However, participants with mild-moderate sarcopenia exhibited higher baseline PT and MQ, with differences in strength improvements at 12 weeks (EONS > CONS, P = .032) in those with normal grip strength. There were no treatment differences based on sarcopenic severity for either grip strength or gait speed. Conclusion ONS improved strength outcomes in malnourished older adults with sarcopenia. In those with mild-moderate sarcopenia, but not severe sarcopenia, consumption of the EONS improved leg muscle strength and quality compared with the standard CONS.

Original languageEnglish (US)
Pages (from-to)1044-1055
Number of pages12
JournalJournal of the American Medical Directors Association
Issue number11
StatePublished - Nov 1 2016


  • Elderly
  • enteral nutrition
  • gait speed
  • handgrip strength
  • isokinetic strength
  • medical nutrition therapy
  • muscle
  • nutrition-only intervention
  • performance

ASJC Scopus subject areas

  • General Nursing
  • Health Policy
  • Geriatrics and Gerontology


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