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Readmission and mortality in malnourished, older, hospitalized adults treated with a specialized oral nutritional supplement: A randomized clinical trial
Open accessAbstract
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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“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measured
The cited source says what the claim attributes to it.
In the citing paper
“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 cited source says what the claim attributes to it.
In the citing paper
“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 cited source says what the claim attributes to it.
In the citing paper
“One of the largest RCTs to date (NOURISH study; n ¼ 652 patients aged 65 years or more with medical conditions) on in-and post hospital (¼continued) nutritional support reported lower 90-day mortality in the IG receiving ONS twice a day (one drink providing 350 kcal, 20 g protein, 1.5 g calcium-bHMB), 160 IU vitamin D and other essential micronutrients) for three months compared to the CG patients”
From ESPEN guideline on nutritional support for polymorbid medical inpatients (2023) · cites this paper as [9]
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“While readmission rates as an indicator of clinical course e.g. were not reduced after three months in one of the largest trials to date (level of evidence: 1þþ) [9] in geriatric patients (level of evidence: 1þ) [131] or in older patients (level of evidence: 1-) [132]”
From ESPEN guideline on nutritional support for polymorbid medical inpatients (2023) · cites this paper as [9]
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“Similar results were also found within the NOURISH study with a significant survival benefit associated with nutritional support [9] (Level of evidence: 1þþ).”
From ESPEN guideline on nutritional support for polymorbid medical inpatients (2023) · cites this paper as [9]
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“…rates as an indicator of clinical course e.g. were not reduced after three months in one of the largest trials to date (level of evidence: 1 þþ ) [9] in geriatric patients ( level of evidence: 1 þ ) [131 ] or in older patients ( level of evidence: 1) [132], it was signi fi cantly reduced after…”
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Metadata
- 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)
- 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
- hybrid
- doi.org
- 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 (medical) › 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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