A Trial of an Oral Nutritional Supplement in Older Hospitalized Patients - NOURISH Study

Study Overview
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Brief Summary
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Evaluate effects of an oral nutritional supplement on healthcare outcomes in older hospitalized adults. Also referred to as the NOURISH Study - Nutrition effect On Unplanned Readmissions and Survival in Hospitalized patients.

Official Title
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A Randomized Double Blinded Controlled Trial of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients

Conditions
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Hospitalized Elderly

Intervention / Treatment
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* Other: Ready to Drink Flavored Beverage
* Other: Ready to drink flavored beverage w/ AN 777


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥ 65 years of age. Admitted to hospital with diagnosis of heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease. Subjective Global Assessment rating of B or C. Length of hospital stay anticipated to be > 3 days and < 12 days Able to consume foods and beverages orally. Functionally ambulatory during the 30 days prior to admission. Exclusion Criteria: Uncontrolled hypertension Diagnosis of diabetes Current active cancer or recently treated cancer Impaired renal function Liver failure, acute Hepatitis, or hepatic encephalopathy Active tuberculosis. HIV Disorder of gastrointestinal tract Autoimmune disorder Intubation, and/or tube or parenteral feeding. Severe dementia or delirium, brain metastases, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures Allergy or intolerance to any of the ingredients in the study products. Body mass index of ≥ 40 kg/m2. Resident in a nursing home or other residential facility. Planned surgery during course of the study.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Ready to drink flavored beverage<br> | Other: Ready to Drink Flavored Beverage<br>* 2 servings a day<br>|
| Experimental: Ready to drink flavored beverage w/ AN 777<br> | Other: Ready to drink flavored beverage w/ AN 777<br>* 2 servings a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to hospital or death |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to hospital or death |  | 30 and 60 days | 
| Hospital Days |  | 90 days | 
| Activities of Daily Living | Katz Activities of Daily Living at entry and 90 days | 90 days |