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

https://doi.org/10.1016/j.jamda.2016.08.009Get rights and content
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Abstract

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.

Keywords

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

Cited by (0)

This clinical trial was funded by Abbott Nutrition (clinicaltrials.gov identifier: NCT01191125). JTC is also supported by the US Department of Agriculture National Institute of Food and Agriculture Hatch project, Accession Number: 1009500.

JTC had a significant financial interest in Abbott Nutrition as a paid consultant whose responsibilities were to assist with clinical trial design, analysis, interpretation of data, and training key study personnel at all clinical trial sites. In accordance with its conflict of interest policy, the University of Nebraska-Lincoln's Conflict of Interest Review Committee has determined that this must be disclosed. SP, DH, and VAM are employees at and stockholders of Abbott Nutrition. AJC-J has received grants and research support from Abbott Nutrition, Novartis, Nutricia, and Regeneron and participates in speaker's bureaus sponsored by Abbott Nutrition and Nutricia. FL reported no conflicts of interests, while MH and MZ did not report any potential conflicts of interest.