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

Phase 3

Completed

• Conditions: Hospitalized Elderly

• Registration Number: NCT01626742
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-25
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-24
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 652

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Return to hospital or death	90 days

Secondary Outcome Measures

Name	Time	Method
Return to hospital or death	30 and 60 days
Hospital Days	90 days
Activities of Daily Living	90 days	Katz Activities of Daily Living at entry and 90 days

Trial Locations

Locations (118)

Auburn University; 🇺🇸 Auburn, Alabama, United States

Birmingham Heart Clinic; 🇺🇸 Birmingham, Alabama, United States

Heart Center Research, LLC; 🇺🇸 Huntsville, Alabama, United States

HealthScan Research; 🇺🇸 Montgomery, Alabama, United States

Scottsdale Healthcare; 🇺🇸 Scottsdale, Arizona, United States

Baptist Health Center for Clinical Research; 🇺🇸 Little Rock, Arkansas, United States

UCSF Fresno; 🇺🇸 Fresno, California, United States

St. Jude Medical Center; 🇺🇸 Fullerton, California, United States

Glendale Adventist Medical Center; 🇺🇸 Glendale, California, United States

eStudySite, La Mesa; 🇺🇸 La Mesa, California, United States

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