NCT01626742CompletedPhase 3
A Randomized Double Blinded Controlled Trial of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Abbott Nutrition
- Enrollment
- 652
- Locations
- 119
- Primary Endpoint
- Return to hospital or death
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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/m
- •Resident in a nursing home or other residential facility.
- •Planned surgery during course of the study.
Arms & Interventions
Ready to drink flavored beverage
Placebo Comparator
Intervention: Ready to Drink Flavored Beverage (Other)
Ready to drink flavored beverage w/ AN 777
Experimental
Intervention: Ready to drink flavored beverage w/ AN 777 (Other)
Outcomes
Primary Outcomes
Return to hospital or death
Time Frame: 90 days
Secondary Outcomes
- Return to hospital or death(30 and 60 days)
- Hospital Days(90 days)
- Activities of Daily Living(90 days)
Investigators
Study Sites (119)
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