title: Readmission and mortality in malnourished, older, hospitalized adults treated with a specialized oral nutritional supplement: A randomized clinical trial.
abstract: BACKGROUND
  Hospitalized, malnourished older adults have a high risk of readmission and mortality.
  
  
  OBJECTIVE
  Evaluation of a high-protein oral nutritional supplement (HP-HMB) containing beta-hydroxy-beta-methylbutyrate on postdischarge outcomes of nonelective readmission and mortality in malnourished, hospitalized older adults.
  
  
  METHODS
  Multicenter, randomized, placebo-controlled, double-blind trial.
  
  
  METHODS
  Inpatient and posthospital discharge.
  
  
  METHODS
  Older (≥65 years), malnourished (Subjective Global Assessment [SGA] class B or C) adults hospitalized for congestive heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease.
  
  
  METHODS
  Standard-of-care plus HP-HMB (n = 328) or a placebo supplement (n = 324), 2 servings/day.
  
  
  METHODS
  Primary composite endpoint was 90-day postdischarge incidence of death or nonelective readmission. Other endpoints included 30- and 60-day postdischarge incidence of death or readmission, length of stay (LOS), SGA class, body weight, and activities of daily living (ADL).
  
  
  RESULTS
  The primary composite endpoint was similar between HP-HMB (26.8%) and placebo (31.1%). No between-group differences were observed for 90-day readmission rate, but 90-day mortality was significantly lower with HP-HMB relative to placebo (4.8% vs. 9.7%; relative risk 0.49, 95% confidence interval [CI], 0.27 to 0.90; p = 0.018). The number-needed-to-treat to prevent 1 death was 20.3 (95% CI: 10.9, 121.4). Compared with placebo, HP-HMB resulted in improved odds of better nutritional status (SGA class, OR, 2.04, 95% CI: 1.28, 3.25, p = 0.009) at day 90, and an increase in body weight at day 30 (p = 0.035). LOS and ADL were similar between treatments.
  
  
  CONCLUSIONS
  Limited generalizability; patients represent a selected hospitalized population.
  
  
  CONCLUSIONS
  Although no effects were observed for the primary composite endpoint, compared with placebo HP-HMB decreased mortality and improved indices of nutritional status during the 90-day observation period.
  
  
  BACKGROUND
  www.ClinicalTrials.govNCT01626742.
authors.affiliation: Center for Translational Research in Aging & Longevity, Department of Health & Kinesiology, Texas A&M University, 1700 Research Parkway, College Station, TX 77845, USA. Electronic address: nep.deutz@ctral.org.
authors.forename: Nicolaas E
authors.initials: NE
authors.lastname: Deutz
authors.affiliation: Department of Family Medicine, Medical University of South Carolina, 5 Charleston Center Dr, Charleston, SC, USA. Electronic address: matheson@musc.edu.
authors.forename: Eric M
authors.initials: EM
authors.lastname: Matheson
authors.affiliation: Brody School of Medicine, East Carolina University, 600 Moye Blvd, Greenville, NC, USA. Electronic address: mataresel@ecu.edu.
authors.forename: Laura E
authors.initials: LE
authors.lastname: Matarese
authors.affiliation: Abbott Nutrition, Research and Development, 3300 Stelzer Rd, Columbus, OH, USA. Electronic address: Menghua.Luo@abbott.com.
authors.forename: Menghua
authors.initials: M
authors.lastname: Luo
authors.affiliation: Abbott Nutrition, Research and Development, 3300 Stelzer Rd, Columbus, OH, USA. Electronic address: geraldine.baggs@abbott.com.
authors.forename: Geraldine E
authors.initials: GE
authors.lastname: Baggs
authors.affiliation: Abbott Nutrition, Research and Development, 3300 Stelzer Rd, Columbus, OH, USA. Electronic address: jeffrey.l.nelson@abbott.com.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Nelson
authors.affiliation: Abbott Nutrition, Research and Development, 3300 Stelzer Rd, Columbus, OH, USA; Faculty of Medicine, Mansoura University, Egypt. Electronic address: Refaat.Hegazi@abbott.com.
authors.forename: Refaat A
authors.initials: RA
authors.lastname: Hegazi
authors.affiliation: Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign, 905 S. Goodwin Ave, Urbana, IL, USA. Electronic address: tappende@illinois.edu.
authors.forename: Kelly A
authors.initials: KA
authors.lastname: Tappenden
authors.affiliation: Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, 1648 Pierce Dr NE, Atlanta, GA, USA. Electronic address: tzieg01@emory.edu.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Ziegler
mesh_terms: D000203:Activities of Daily Living; D000208:Acute Disease; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D001835:Body Weight; D004044:Dietary Proteins / Q000008:administration & dosage* / Q000032:analysis; D019587:Dietary Supplements; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006333:Heart Failure / Q000150:complications / Q000401:mortality; D006760:Hospitalization; D006801:Humans; D007902:Length of Stay; D008297:Male; D044342:Malnutrition / Q000150:complications / Q000178:diet therapy*; D009203:Myocardial Infarction / Q000150:complications / Q000401:mortality; D009752:Nutritional Status; D010359:Patient Readmission; D011014:Pneumonia / Q000150:complications / Q000401:mortality; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000401:mortality; D016896:Treatment Outcome; D014631:Valerates / Q000008:administration & dosage
chemical_list: D004044:Dietary Proteins; D014631:Valerates; C004961:beta-hydroxyisovaleric acid
keywords: High-protein beta-hydroxy-beta-methylbutyrate; Hospitalization; Lean body mass; Malnourished; NOURISH study; Oral nutritional supplement