The clinical trial backed by specialists nutrition firm Abbott did not achieve significant results for combined endpoints of hospital readmission rates and mortality, but did show improvements in body weight, nutritional status and vitamin D levels compared to placebo.
"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," lead author Nicolaas Deutz from Texas A&M University said in a release.
The participants were given a ready-to-drink oral nutritional supplements (ONS) produced by Abbott, which provided 350 kcal, 20 g protein, 11 g fat, 44 g carbohydrate, 1.5 g calcium-Beta-hydroxybeta-methylbutyrate (HMB), 160 IU (International Units) vitamin D and other essential micronutrients.
The researchers said beta-hydroxybeta-methylbutyrate (HMB) in a high protein supplement may help prevent protein degradation during catabolic illness.
Malnutrition in older adults
Malnutrition in older hospitalised adults is a risk factor for hospital readmission, and is associated with higher mortality after discharge. Even short times in hospital can result in loss of lean body mass, which can affect health outcomes.
ONS have been extensively studied in older patients and can increase body weight and improve nutritional status. The effect of such products on hospital readmission and mortality rates has previously been unclear due to research methods and inconsistent results.
Refaat Hegazi, Abbott global medical director and study author, said: "While the prevalence of malnutrition is high, research shows that less than 2% of malnourished patients in the hospital receive an oral nutrition supplement. Nutrition must be one of our critical tools to help adults live longer, better lives."
The NOURISH (Nutrition effect On Unplanned Readmissions and Survival in Hospitalized patients) study - one of the largest nutrition clinical studies of its kind - was a prospective, randomized, double-blind, placebo-controlled trial to assess the effects of a high protein oral supplement on hospital readmission and mortality in older adults.
Researchers from institutions including Texas A&M University, Medical University of South Carolina, East Carolina University, University of Illinois at Urbana-Champaign, and Emory University School of Medicine evaluated 652 malnourished adults, aged 65 or older who were admitted to hospital with heart or lung disease.
Participants were randomised to receive either the high protein beta-hydroxybeta-methylbutyrate (HP-HMB) supplement or placebo twice daily during hospitalisation and 90 days after discharge.
Results showed no significant differences between the two groups for the primary composite (i.e. combined) endpoint of hospital readmissions or death, but health outcomes were improved and there was a 50% lower death rate 90 days post discharge.
Although the results were significant, lack of data on additional intake other than HP-HMB was a study limitation, and the specific components in HP-HMB responsible for the reduced mortality could not be determined, said the authors.
The commercially available version of the specialised nutrition supplement evaluated in the study is 'Ensure Plus Advance' in Europe, developed and marketed by Abbott.
Asked about the products’ clinical use Carole Glencorse, medical director for Abbott’s nutrition business in Europe, Middle East and Africa, told NutraIngredients: “Ensure Plus Advance is intended for use under the care of a healthcare professional. It's suitable for adults aged over 65 years with, or at risk of, malnutrition in both the hospital and community setting. Suitability should be determined by the recommending healthcare professional based on the person’s underlying clinical condition.”
Source: Clinical Nutrition
Published online ahead of print, http://dx.doi.org/10.1016/j.clnu.2015.12.010
“Readmission and mortality in malnourished, older, hospitalized adults treated with a specialized oral nutritional supplement: A randomized clinical trial”
Authors: N.E. Deutz et al.