Nicolaas E Deutz1, Eric M Matheson2, Laura E Matarese3, Menghua Luo4, Geraldine E Baggs5, Jeffrey L Nelson6, Refaat A Hegazi7, Kelly A Tappenden8, Thomas R Ziegler9. 1. 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. 2. Department of Family Medicine, Medical University of South Carolina, 5 Charleston Center Dr, Charleston, SC, USA. Electronic address: matheson@musc.edu. 3. Brody School of Medicine, East Carolina University, 600 Moye Blvd, Greenville, NC, USA. Electronic address: mataresel@ecu.edu. 4. Abbott Nutrition, Research and Development, 3300 Stelzer Rd, Columbus, OH, USA. Electronic address: Menghua.Luo@abbott.com. 5. Abbott Nutrition, Research and Development, 3300 Stelzer Rd, Columbus, OH, USA. Electronic address: geraldine.baggs@abbott.com. 6. Abbott Nutrition, Research and Development, 3300 Stelzer Rd, Columbus, OH, USA. Electronic address: jeffrey.l.nelson@abbott.com. 7. Abbott Nutrition, Research and Development, 3300 Stelzer Rd, Columbus, OH, USA; Faculty of Medicine, Mansoura University, Egypt. Electronic address: Refaat.Hegazi@abbott.com. 8. 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. 9. Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, 1648 Pierce Dr NE, Atlanta, GA, USA. Electronic address: tzieg01@emory.edu.
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. DESIGN: Multicenter, randomized, placebo-controlled, double-blind trial. SETTING: Inpatient and posthospital discharge. PATIENTS: 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. INTERVENTIONS:Standard-of-care plus HP-HMB (n = 328) or a placebo supplement (n = 324), 2 servings/day. MEASUREMENTS: 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. LIMITATIONS: 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. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.govNCT01626742.
RCT Entities:
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. DESIGN: Multicenter, randomized, placebo-controlled, double-blind trial. SETTING: Inpatient and posthospital discharge. PATIENTS: 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. INTERVENTIONS: Standard-of-care plus HP-HMB (n = 328) or a placebo supplement (n = 324), 2 servings/day. MEASUREMENTS: 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. LIMITATIONS: 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. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.govNCT01626742.
Authors: Dillon K Walker; John J Thaden; Agata Wierzchowska-McNew; Marielle P K J Engelen; Nicolaas E P Deutz Journal: J Chromatogr B Analyt Technol Biomed Life Sci Date: 2016-11-09 Impact factor: 3.205
Authors: Mariëlle P K J Engelen; Renate Jonker; John J Thaden; Gabriella A M Ten Have; Moon Sun Jeon; Srinivasan Dasarathy; Nicolaas E P Deutz Journal: Clin Nutr Date: 2020-01-29 Impact factor: 7.324
Authors: H Keller; M Laporte; H Payette; J Allard; P Bernier; D Duerksen; L Gramlich; K Jeejeebhoy Journal: Eur J Clin Nutr Date: 2017-02-22 Impact factor: 4.016