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

Phase 3
Completed
Conditions
Hospitalized Elderly
Interventions
Other: Ready to drink flavored beverage w/ AN 777
Other: Ready to Drink Flavored Beverage
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

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
Arm && Interventions
GroupInterventionDescription
Ready to drink flavored beverage w/ AN 777Ready to drink flavored beverage w/ AN 777-
Ready to drink flavored beverageReady to Drink Flavored Beverage-
Primary Outcome Measures
NameTimeMethod
Return to hospital or death90 days
Secondary Outcome Measures
NameTimeMethod
Return to hospital or death30 and 60 days
Hospital Days90 days
Activities of Daily Living90 days

Katz Activities of Daily Living at entry and 90 days

Trial Locations

Locations (118)

MetroHealth Medical Center

🇺🇸

Cleveland, Ohio, United States

University of Miami Miller School of Medicine

🇺🇸

Miami, Florida, United States

Cuervo Clinical Research Group, Inc

🇺🇸

Miami, Florida, United States

Health & Life Research Solutions Inc.

🇺🇸

Miami, Florida, United States

HealthScan Research

🇺🇸

Montgomery, Alabama, United States

Auburn University

🇺🇸

Auburn, Alabama, United States

Heart Center Research, LLC

🇺🇸

Huntsville, 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

eStudySite, Oceanside

🇺🇸

Oceanside, California, United States

South Orange County Surgical Medical Group

🇺🇸

Laguna Hills, California, United States

Novo Research dba FCPP Research

🇺🇸

Modesto, California, United States

Pulmonary Consultant & Primary Physicians Medical Group

🇺🇸

Orange, California, United States

Los Angeles Biomedical Research Institution

🇺🇸

Torrance, California, United States

Medical Center of the Rockies

🇺🇸

Loveland,, Colorado, United States

UConn Health Center

🇺🇸

Farmington, Connecticut, United States

ZASA Clinical Research

🇺🇸

Atlantis, Florida, United States

Visions Clinical Research, LLC

🇺🇸

Boynton Beach, Florida, United States

Pulmonary and Sleep of Tampa Bay

🇺🇸

Brandon, Florida, United States

Seidman Clinical Trials

🇺🇸

Delray Beach, Florida, United States

Morton Plant Mease HealthCare

🇺🇸

Clearwater, Florida, United States

Broward Health - Broward General Medical Center

🇺🇸

Ft. Lauderdale, Florida, United States

In Vivo Clinical Research

🇺🇸

Hialeah, Florida, United States

Jacksonville Center for Clinical Research

🇺🇸

Jacksonville, Florida, United States

River City Clinical Research

🇺🇸

Jacksonville, Florida, United States

The Cardiovascular Center, P.A.

🇺🇸

Lake Mary, Florida, United States

Watson Clinic Center for Research, Inc.

🇺🇸

Lakeland, Florida, United States

Largo Medical Center

🇺🇸

Largo, Florida, United States

Panama Clinical Research Associates

🇺🇸

Lynn Haven, Florida, United States

Ocala Research Institute, Inc.

🇺🇸

Ocala, Florida, United States

Cardiovascular Institute of Northwest Florida

🇺🇸

Panama City, Florida, United States

Regenerate Clinical Trials

🇺🇸

South Miami, Florida, United States

Advanced Clinical Research Group

🇺🇸

Stuart, Florida, United States

Emory University

🇺🇸

Atlanta, Georgia, United States

Emory University Hospital

🇺🇸

Atlanta, Georgia, United States

Columbus Regional Research Institute

🇺🇸

Columbus, Georgia, United States

Northwestern University

🇺🇸

Chicago, Illinois, United States

Atlanta Institute for Medical Research

🇺🇸

Decatur, Georgia, United States

Kootenai Heart Clinics, LLC

🇺🇸

Coeur d' Alene, Idaho, United States

Edward Hines VA Hospital

🇺🇸

Hines, Illinois, United States

University of Illinois at Chicago

🇺🇸

Chicago, Illinois, United States

University of Iowa Hospitals and Clinics

🇺🇸

Iowa City, Iowa, United States

King's Daughters Medical Center, Kentucky Heart Foundation , Inc.

🇺🇸

Ashland, Kentucky, United States

St Vincent Medical Group

🇺🇸

Indianapolis, Indiana, United States

Research Concierge, LLC

🇺🇸

Hartford, Kentucky, United States

Kentucky Lung Clinic

🇺🇸

Hazard, Kentucky, United States

Louisiana State University Health Science Center

🇺🇸

Shreveport, Louisiana, United States

Johns Hopkins University Hospital

🇺🇸

Baltimore, Maryland, United States

Maine Research Associates

🇺🇸

Auburn, Maine, United States

Eastern Maine Medical Center

🇺🇸

Bangor, Maine, United States

MedStar Health Research Institute - MedStar Union Memorial Hospital

🇺🇸

Baltimore, Maryland, United States

McLaren-Flint Research Institute

🇺🇸

Flint, Michigan, United States

William Beaumont Hospital

🇺🇸

Royal Oak, Michigan, United States

Activmed Practices & Research, Inc

🇺🇸

Methuen, Massachusetts, United States

Baystate Medical Center

🇺🇸

Springfield, Massachusetts, United States

St John Hospital & Medical Center

🇺🇸

Grosse Pointe Woods, Michigan, United States

Bronson Healthcare Group

🇺🇸

Kalamazoo, Michigan, United States

HealthEast St Joseph's Hospital

🇺🇸

St. Paul, Minnesota, United States

St Anthony's Medical Center

🇺🇸

St. Louis, Missouri, United States

David M Headley

🇺🇸

Port Gibson, Mississippi, United States

VA Sierra Nevada Health Care System

🇺🇸

Reno, Nevada, United States

Hackensack University Medical Center

🇺🇸

Hackensack, New Jersey, United States

Hunterdon Cardiovascular Associates

🇺🇸

Flemington, New Jersey, United States

Virtua Medical Group

🇺🇸

Moorestown, New Jersey, United States

Erie County Medical Center

🇺🇸

Buffalo, New York, United States

Associated Cardiovascular Consultants of Lourdes

🇺🇸

Voorhees, New Jersey, United States

Columbia University Medical Center

🇺🇸

New York, New York, United States

Rochester General Hospital

🇺🇸

Rochester, New York, United States

Mission Hospital

🇺🇸

Asheville, North Carolina, United States

East Carolina University

🇺🇸

Greenville, North Carolina, United States

Wake Forest University Health Sciences

🇺🇸

Winston Salem, North Carolina, United States

Sanford Clinic North-Fargo

🇺🇸

Fargo, North Dakota, United States

Riverside Methodist Hospital

🇺🇸

Columbus, Ohio, United States

North Ohio Research

🇺🇸

Elyria, Ohio, United States

Doylestown Hospital

🇺🇸

Doylestown, Pennsylvania, United States

Physician Specialists of Northern Lancaster County Medical Group

🇺🇸

Ephrata, Pennsylvania, United States

Drexel University College of Medicine

🇺🇸

Philadelphia, Pennsylvania, United States

Donald Guthrie Foundation for Education and Research, Inc.

🇺🇸

Sayre, Pennsylvania, United States

Grand View Hospital Clinical Research

🇺🇸

Sellersville, Pennsylvania, United States

Pinnacle Health Cardiovascular Institute, Inc.

🇺🇸

Wormleysburg, Pennsylvania, United States

Palmetto Senior Primary Care Practice

🇺🇸

Columbia, South Carolina, United States

Sanford Clinic Family Medicine

🇺🇸

Sioux Falls, South Dakota, United States

Texas A&M University

🇺🇸

College Station, Texas, United States

Advanced Clinical Research Associates

🇺🇸

Plano, Texas, United States

Tanner Clinic

🇺🇸

Layton, Utah, United States

Carilion Medical Center Geriatrics

🇺🇸

Roanoke, Virginia, United States

The Hope Heart Institute

🇺🇸

Bellevue, Washington, United States

San Juan Bautista School of Medicine

🇵🇷

Caguas, Puerto Rico

Western Cardiovascular Surgery of Puerto Rico

🇵🇷

Mayaguez, Puerto Rico

VA Caribbean Healthcare System

🇵🇷

San Juan, Puerto Rico

Research and Cardiovascular Corp

🇵🇷

Ponce, Puerto Rico

eStudySite, Las Vegas

🇺🇸

Las Vegas, Nevada, United States

The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital

🇺🇸

Cincinnati, Ohio, United States

South Texas Cardiovascular Consultants

🇺🇸

San Antonio, Texas, United States

Sonterra Clinical Research

🇺🇸

San Antonio, Texas, United States

STHS Heart, LLC

🇺🇸

Nashville, Tennessee, United States

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

Birmingham Heart Clinic

🇺🇸

Birmingham, Alabama, United States

Alegent Creighton Health Heart & Vascular Specialists

🇺🇸

Omaha, Nebraska, United States

Creighton University

🇺🇸

Omaha, Nebraska, United States

Aurora Denver Cardiology Associates, PC

🇺🇸

Aurora, Colorado, United States

Cardiology Consultants

🇺🇸

Pensacola, Florida, United States

Jewish Hospital & St Mary's Healthcare

🇺🇸

Louisville, Kentucky, United States

Novant Clinical Research Institute

🇺🇸

Winston-Salem, North Carolina, United States

PMG research of Charleston

🇺🇸

Charleston, South Carolina, United States

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

University of Florida

🇺🇸

Gainesville, Florida, United States

Ochsner Medical Center

🇺🇸

New Orleans, Louisiana, United States

University of New Mexico Health Sciences Center

🇺🇸

Albuquerque, New Mexico, United States

Sentara Cardiovascular Research Institute

🇺🇸

Norfolk, Virginia, United States

The Reading Hospital and Medical Center

🇺🇸

West Reading, Pennsylvania, United States

Cardiology Partners Clinical Research Institute

🇺🇸

Wellington, Florida, United States

Crittenton Hospital Medical Center

🇺🇸

Rochester Hills, Michigan, United States

Salem VA Medical Center

🇺🇸

Salem, Virginia, United States

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