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

J Am Med Dir Assoc. 2016 Nov 1;17(11):1044-1055. doi: 10.1016/j.jamda.2016.08.009.


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.

Trial registration: NCT01191125.

Keywords: Elderly; enteral nutrition; gait speed; handgrip strength; isokinetic strength; medical nutrition therapy; muscle; nutrition-only intervention; performance.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Dietary Proteins / administration & dosage*
  • Dietary Supplements*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Malnutrition*
  • Muscle, Skeletal / physiology
  • Sarcopenia*


  • Dietary Proteins

Associated data