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Cited by 472Nutrition and Health in AgingClinical Nutrition and GastroenterologyDialysis and Renal Disease Management

Readmission and mortality in malnourished, older, hospitalized adults treated with a specialized oral nutritional supplement: A randomized clinical trial

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Deutz, Nicolaas E., Matheson, Eric M., Matarese, Laura E., Luo, Menghua, Baggs, Geraldine E., Nelson, Jeffrey L., Hegazi, Refaat A., Tappenden, Kelly A. +1 more·2016·Clinical Nutrition
DOI 10.1016/j.clnu.2015.12.010
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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.

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  • Recent large randomized controlled trials over the last five years have provided important new evidence showing that nutritional support can reduce morbidity and other complications in polymorbid patients.

    “Yet, recent large randomized controlled trials (RCT) over the last five years have provided important new evidence showing that nutritional support can reduce morbidity and other complications in polymorbid patients, which may help us to answer these question and formulate evidence-based recommendations [8,9].”

    From ESPEN guideline on nutritional support for polymorbid medical inpatients (2023) · cites this paper as [9]

    The Discussion describes NOURISH as a large randomized trial in malnourished older adults hospitalized for several conditions. The Results (§3.3; page unavailable) report lower 90-day mortality with the specialized supplement, but no significant reduction in readmissions or the primary composite outcome. The Safety results (§3.5; page unavailable) also do not show fewer adverse events, so this trial does not establish the claimed reduction in morbidity and other complications across polymorbid patients. (LLM, conf=0.88)

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  • Early detection and intervention against disease-related malnutrition has been shown to improve nutritional status and reduce complications during hospital stay and non-elective readmissions.

    “Early detection and intervention against DRM has been shown to improve nutritional status and reduce complications during hospital stay and non-elective readmissions [9,43] (Level of Evidence 1þþ for both).”

    From ESPEN guideline on nutritional support for polymorbid medical inpatients (2023) · cites this paper as [9]

    Section 3.4 (page unavailable) reports better nutritional status at day 90 with the supplement. But section 3.3 found no significant reduction in nonelective readmissions, and the paper does not show that early detection reduced complications during the hospital stay. The claim therefore extends beyond this trial’s findings. (LLM, conf=0.90)

    Experimental — accuracy not yet measured

  • According to the NOURISH study, high protein bHMB ONS may help with the maintenance of muscle mass during hospital stay.

    “According to the NOURISH study, a multicenter RCT which included 652 malnourished inpatients, high protein bHMB ONS may not yield a difference when compared with placebo on readmission rates, but may help with the maintenance of muscle mass during hospital stay and result in a significant decrease in post-discharge mortality (90-day mortality was 4.8% in the IG vs. 9.7% in the CG; RR 0.49, 95% CI”

    From ESPEN guideline on nutritional support for polymorbid medical inpatients (2023) · cites this paper as [9]

    The Introduction and Discussion say that protein and HMB may help prevent lean-body-mass loss, which supports the claim as a possibility. But the trial’s reported outcomes do not include muscle mass during hospitalization, so the NOURISH study did not establish that its supplement maintained muscle mass during the hospital stay. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

  • In a subgroup of patients with chronic obstructive pulmonary disease from the NOURISH study, the intervention group had a significant decreased mortality risk compared to the control group (1.83%, 2.75%, 2.75% vs 6.67%, 9.52% and 10.48%, p=0.0395, 0.0193, 0.0113, respectively).

    “The effects of this ONS were also positive in a subgroup of patients with chronic obstructive pulmonary disease (COPD) from the same study, where the IG had significant decreased mortality risk compared to the CG (1.83%, 2.75%, 2.75% vs. 6.67%,9.52% and 10.48%, p ¼ 0.0395, 0.0193, 0.0113, respectively).”

    From ESPEN guideline on nutritional support for polymorbid medical inpatients (2023) · cites this paper as [9]

    Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

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  • In most RCTs on intervention with ONS, sip feeds were given for at least three months, whereas individualized nutritional support was usually carried out for longer periods (e.g. four months in Persson et al., or six months in Feldblum et al., Casals et al., Bonilla-Palomas et al., and Yang et al.).

    “However, in most RCTs on intervention with ONS, the sip feeds were given for at least three months [9,120e124], whereas individualized nutritional support (which might include ONS where necessary) was usually carried out for longer periods (e.g.four months in the study by Persson et al. [119], or six months in the studies of Feldblum et al. [116], Casals et al. [118], Bonilla-Palomas et al. [126],”

    From ESPEN guideline on nutritional support for polymorbid medical inpatients (2023) · cites this paper as [9]

    Split into 2 atoms — 1 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 1 unverifiable. Expand the claim to see per-atom verdicts.

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Authors
Deutz, N. E., Matheson, E. M., Matarese, L. E., Luo, M., Baggs, G. E., Nelson, J. L., Hegazi, R. A., Tappenden, K. A., & Ziegler, T. R.
Affiliations
  • Texas A&M University (US)
  • Medical University of South Carolina (US)
  • East Carolina University (US)
  • Abbott Nutrition (United States) (US)
  • Mansoura University (EG)
  • University of Illinois Urbana-Champaign (US)
  • Emory University (US)
Corresponding author
  • Deutz, Nicolaas E.
  • Matheson, Eric M.
  • Matarese, Laura E.
  • Luo, Menghua
  • Baggs, Geraldine E.
  • Nelson, Jeffrey L.
  • Hegazi, Refaat A.
  • Tappenden, Kelly A.
  • Ziegler, Thomas R.
ORCID
Venue
Clinical Nutrition
Publisher
Elsevier BV
Published
2016-02
Volume
35
Issue
1
Pages
18-26
ISSN
0261-5614 (ISSN-L)
DOI
10.1016/j.clnu.2015.12.010
OpenAlex
W2257285672
Cited by
472
References
31
Citations by year
2026: 36 · 2025: 46 · 2024: 65 · 2023: 33 · 2022: 58 · 2021: 55 · 2020: 44 · 2019: 45 · 2018: 37 · 2017: 29 · 2016: 23
FWCI
35.92
Type
journal article
Language
en
Open access
Licence
Locations
  • Clinical Nutrition (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • The Scholarship East Carolina University's Institutional Repository (East Carolina University) (submittedVersion)
Funders
Ohio State University
Topics
  • Health Sciences › Medicine › Physiology › Nutrition and Health in Aging
  • Health Sciences › Nursing › Nutrition and Dietetics › Clinical Nutrition and Gastroenterology
  • Health Sciences › Medicine › Nephrology › Dialysis and Renal Disease Management
Keywords
oral nutritional supplements, beta-hydroxy-beta-methylbutyrate, malnutrition, older adults, hospital readmission, post-discharge mortality, nutritional status, congestive heart failure, acute myocardial infarction, pneumonia, chronic obstructive pulmonary disease, length of hospital stay, activities of daily living, body weight, post-discharge care, number needed to treat
MeSH terms
Activities of Daily Living, Acute Disease, Administration, Oral, Aged, Aged, 80 and over, Body Weight, Dietary Proteins, Double-Blind Method, Female, Heart Failure, Hospitalization, Humans, Length of Stay, Male, Myocardial Infarction, Nutritional Status, Patient Readmission, Pneumonia, Valerates, Treatment Outcome, Dietary Supplements, Endpoint Determination, Pulmonary Disease, Chronic Obstructive, Malnutrition

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