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

Abbott

Status and phase: Completed; Phase 3

Conditions: Hospitalized Elderly

Treatments: Other: Ready to Drink Flavored Beverage; Other: Ready to drink flavored beverage w/ AN 777

Study type: Interventional

Funder types: Industry

Identifiers

NCT01626742

BL01

Details and patient eligibility

About

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.

Enrollment: 652 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female ≥ 65 years of age.
2. Admitted to hospital with diagnosis of heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease.
3. Subjective Global Assessment rating of B or C.
4. Length of hospital stay anticipated to be > 3 days and < 12 days
5. Able to consume foods and beverages orally.
6. Functionally ambulatory during the 30 days prior to admission.

Exclusion criteria

1. Uncontrolled hypertension
2. Diagnosis of diabetes
3. Current active cancer or recently treated cancer
4. Impaired renal function
5. Liver failure, acute Hepatitis, or hepatic encephalopathy
6. Active tuberculosis.
7. HIV
8. Disorder of gastrointestinal tract
9. Autoimmune disorder
10. Intubation, and/or tube or parenteral feeding.
11. 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
12. Allergy or intolerance to any of the ingredients in the study products.
13. Body mass index of ≥ 40 kg/m2.
14. Resident in a nursing home or other residential facility.
15. Planned surgery during course of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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652 participants in 2 patient groups, including a placebo group

Ready to drink flavored beverage

Placebo Comparator group

Treatment:

Other: Ready to Drink Flavored Beverage

Ready to drink flavored beverage w/ AN 777

Experimental group

Treatment:

Other: Ready to drink flavored beverage w/ AN 777