A high-protein nutritional supplement halved mortality risk in older malnourished patients hospitalized because of heart or lung disease, according to a study in .
An intention-to-treat analysis showed that one life could be saved for every 20 patients who received the specialized supplement, reported lead author , of Texas A&M University in College Station, and colleagues.
The study "clearly reinforces the power of nutrition in impacting health outcomes. For the people in this study who were ill and malnourished, nutrition was critical to survival because it helps keep your body, especially your muscles, functioning properly," Deutz said in a statement.
Action Points
- Note that this randomized trial found that a nutritional supplement was associated with reduced mortality in malnourished hospitalized patients.
- Be aware that the prespecified composite primary endpoint (death or readmission) was no different between the groups.
"This is more proof that we need to change the standard and include nutrition as an integral part of care, much like flu shots or aspirin, to help older adults who already have or are at risk for malnutrition and chronic illness," he added.
The NOURISH (Nutrition Effect On Unplanned Readmissions and Survival in Hospitalized Patients) study included 652 malnourished adults 65 or older hospitalized for congestive heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease.
Half of these patients were randomized to receive the oral nutritional supplement, which came in a ready-to-drink pack and contained, among other ingredients, 20 g of protein, 160 IU of vitamin D, and high-protein beta-hydroxy-beta-methylbutyrate, a muscle-preserving ingredient. The other patients received a look-alike placebo. The patients consumed two servings per day during their hospital stay and for 90 days afterward.
The study was double blinded. The main outcome measure was a composite of nonelective readmission to the hospital and death at 90 days post discharge.
Deutz and colleagues found no significant difference between the treatment and placebo groups for the composite endpoint. However, when they looked at mortality apart from hospital readmission, they found that the 90-day mortality rate was significantly lower in the treatment group (4.8%) than the placebo group (9.7%) (relative risk 0.49; 95% CI 0.27-0.90; P=0.018).
Further analysis found the mortality rate was also lower in the treatment group at 30 days (2.9% versus 6.2%; P=0.049) and at 60 days post discharge (4.2% versus 8.7%; P=0.020). Most deaths were due to cardiorespiratory conditions.
The treatment group was also more likely to have achieved better nutritional status at day 90, as measured by the Subjective Global Assessment tool (RR 2.04; 95% CI 1.28-3.25; P=0.009).
Body weight was consistently higher in the treatment group, but this difference was statistically significant only at day 30, when the treatment group had achieved a mean weight gain of 0.55 kg and the placebo group had lost a mean of 0.26 kg (P=0.035).
The post-hoc estimate of the number of patients needing to be treated to prevent one death was 20.3 (95% CI 10.9-121.4).
"Despite efforts in preventing and treating malnutrition, the prevalence of disease-related malnutrition remains consistently high," Deutz and colleagues wrote. "The NOURISH study represents the largest randomized, controlled trial to date evaluating the effects of adding a specialized nutrient-dense oral nutritional supplement therapy to standard of care on hospital readmission and mortality in an older population ..."
"We have long known the detrimental effects of malnutrition on survival and other clinical outcomes. What is less clear is how effectively nutritional repletion alters this poor prognosis," said , of the Vanderbilt University School of Medicine in Nashville, Tenn., in an email to ѻý.
"This is one of few studies showing improved outcomes with an oral nutritional supplement for elderly malnourished hospitalized patients. This is important because it will encourage other studies to duplicate these findings, and to determine which nutritional components are most important in achieving improved clinical outcomes," said Powers, who is a Fellow of the American Geriatrics Society.
"Sources of potential bias include support by the manufacturer, and a very narrow spectrum of patients which were followed. Note also that 25% of the patients had heart failure, a group known for high readmission rates for many factors excluding nutritional status. On the other hand, the study design is sound, the population studied was large, and the statistical methodology extremely well done ..." Powers said.
The nutritional supplement in the study was manufactured by Abbott Nutrition and is commercially available as Ensure Plus Advance in Europe. It is expected to be available this year in the United States under the brand name Ensure Enlive. The ingredients are intended to help repair and rebuild muscle and increase lean body mass.
Disclosures
The study was funded by Abbott Nutrition.
Deutz reported receiving grant funding and consulting fees from Abbott Nutrition. The other study authors had financial relationships with or were employees of Abbott Nutrition.
Powers disclosed no financial relationships with industry.
Primary Source
Clinical Nutrition
Deutz N. E., et al "Readmission and mortality in malnourished, older, hospitalized adults treated with a specialized oral nutritional supplement: a randomized clinical trial" Clinical Nutrition 2016; DOI: 10.1016/j.clnu.2015.12.010.