A Randomized, Double-Blind, Placebo-Controlled Trial of Nutritional Supplementation During Acute Illness
Open accessAbstract
Purpose The study tested whether nutritional support of older patients during acute illness leads to a clinical benefit. Methods In this randomized, double-blind, placebo-controlled study, we randomly assigned 445 hospitalized patients aged 65 to 92 years to receive either a normal hospital diet plus 400 mL oral nutritional supplements (223 subjects) or a normal hospital diet plus a placebo (222 subjects) daily for 6 weeks. The composition of the supplement was such as to provide 995 kcal of energy and 100% of the Reference Nutrient Intakes for vitamins and minerals for a healthy older person. Patients had three assessments: at baseline, at 6 weeks, and at 6 months post-randomization. Outcome measures were 6 months of disability, non-elective readmission and length of hospital stay, discharge destination, morbidity, and mortality. Results Randomization to the supplement group led to a significant improvement in nutritional status. Over 6 months, 65 patients (29%) in the supplements group were readmitted to the hospital compared with 89 patients (40%) in the placebo group (adjusted hazard ratio 0.68 [95% confidence interval 0.49-0.94]). The mean length of hospital stay was 9.4 days in the supplements group compared with 10.1 days in the placebo group. Thirty-two people (14%) died in the supplement group compared with 19 people (9%) in the placebo group at 6 months (adjusted hazard ratio 1.65 [95% confidence interval, 0.93-2.92]). Conclusion Oral nutritional supplementation of acutely ill patients improved nutritional status and led to a statistically significant reduction in the number of non-elective readmissions.
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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 [43]
The Abstract reports improved nutritional status and fewer non-elective readmissions after supplementation in hospitalized patients aged 65–92. The Clinical Outcomes section reports no clinically important difference in infections or length of hospital stay, so this trial does not support the claimed reduction in complications during the hospital stay. It studied supplementation, not early detection of malnutrition. (LLM, conf=0.91)
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Bjelakovic, G., Nikolova, D., Gluud, L. L., Simonetti, R. G., & Gluud, C. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007176.pub2 · Cited by 924 · see citing works
Protein and energy supplementation in elderly people at risk from malnutrition
Milne, A. C., Potter, J., Vivanti, A., & Avenell, A. (2009) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003288.pub3 · Cited by 849 · see citing works
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. (2016) · Clinical Nutrition · doi:10.1016/j.clnu.2015.12.010 · Cited by 472 · see citing works
ESPEN guidelines on nutritional support for polymorbid internal medicine patients
Gomes, F., Schuetz, P., Bounoure, L., Austin, P., Ballesteros-Pomar, M., Cederholm, T., Fletcher, J., Laviano, A., Norman, K., Poulia, K.-A., et al. (2018) · Clinical Nutrition · doi:10.1016/j.clnu.2017.06.025 · Cited by 363 · see citing works
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Current Concepts and Unresolved Questions in Dietary Protein Requirements and Supplements in Adults
Phillips, S. M. (2017) · Frontiers in Nutrition · doi:10.3389/fnut.2017.00013 · Cited by 145 · see citing works
ESPEN guideline on nutritional support for polymorbid medical inpatients
Wunderle, C., Gomes, F., Schuetz, P., Stumpf, F., Austin, P., Ballesteros-Pomar, M. D., Cederholm, T., Fletcher, J., Laviano, A., Norman, K., et al. (2023) · Clinical Nutrition · doi:10.1016/j.clnu.2023.06.023 · Cited by 105 · see citing works
“Commentary 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 1 þþ for both).”
Loss of appetite in acutely ill medical inpatients: physiological response or therapeutic target?
Schütz, P., Bally, M., Stanga, Z., & Keller, U. (2014) · Swiss Medical Weekly · doi:10.4414/smw.2014.13957 · Cited by 78 · see citing works
Nutritional follow-Up after discharge prevents readmission to hospital – a randomized clinical trial
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- Authors
- Gariballa, S., Forster, S., Walters, S., & Powers, H.
- Affiliations
- United Arab Emirates University (AE)
- University of Sheffield (GB)
- Corresponding author
- Gariballa, Salah
- Venue
- The American Journal of Medicine
- Publisher
- Elsevier BV
- Published
- 2006-08
- Volume
- 119
- Issue
- 8
- Pages
- 693-699
- ISSN
- 0002-9343 (ISSN-L)
- OpenAlex
- W2075563350
- Cited by
- 144
- References
- 1
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 5 · 2023: 5 · 2022: 2 · 2021: 6 · 2020: 4 · 2019: 13 · 2018: 3 · 2017: 12 · 2016: 9 · 2015: 8 · 2014: 17 · 2013: 14 · 2012: 9
- FWCI
- 4.99
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The American Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Clinical Nutrition and Gastroenterology
- Health Sciences › Medicine › Physiology › Nutrition and Health in Aging
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutrition and Health Studies
- Keywords
- oral nutritional supplementation, older adults, acute illness, hospitalized patients, nutritional status, length of hospital stay, mortality, disability, discharge disposition, hospital food
- MeSH terms
- Acute Disease, Aged, Aged, 80 and over, Aging, Diet, Double-Blind Method, Erythrocytes, Female, Folic Acid, Humans, Male, Nutritional Physiological Phenomena, Nutritional Status, Placebos, Vitamin B 12, Dietary Supplements
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