A Trial of an Oral Nutritional Supplement in Older Hospitalized Patients - NOURISH Study
NCT ID: NCT01626742
Last Updated: 2015-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
652 participants
INTERVENTIONAL
2012-05-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ready to drink flavored beverage
Ready to Drink Flavored Beverage
2 servings a day
Ready to drink flavored beverage w/ AN 777
Ready to drink flavored beverage w/ AN 777
2 servings a day
Interventions
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Ready to Drink Flavored Beverage
2 servings a day
Ready to drink flavored beverage w/ AN 777
2 servings a day
Eligibility Criteria
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Inclusion Criteria
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
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.
65 Years
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Menghua Luo, MD, PhD
Role: STUDY_CHAIR
Abbott Nutrition
Jeffrey Nelson, PhD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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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
South Orange County Surgical Medical Group
Laguna Hills, California, United States
Novo Research dba FCPP Research
Modesto, California, United States
eStudySite, Oceanside
Oceanside, California, United States
Pulmonary Consultant & Primary Physicians Medical Group
Orange, California, United States
Los Angeles Biomedical Research Institution
Torrance, California, United States
Aurora Denver Cardiology Associates, PC
Aurora, Colorado, 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
Morton Plant Mease HealthCare
Clearwater, Florida, United States
Seidman Clinical Trials
Delray Beach, Florida, United States
Broward Health - Broward General Medical Center
Fort Lauderdale, Florida, United States
University of Florida
Gainesville, Florida, United States
In Vivo Clinical Research
Hialeah, Florida, United States
River City Clinical Research
Jacksonville, Florida, United States
Jacksonville Center for 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
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
Ocala Research Institute, Inc.
Ocala, Florida, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States
Cardiology Consultants
Pensacola, Florida, United States
Regenerate Clinical Trials
South Miami, Florida, United States
Advanced Clinical Research Group
Stuart, Florida, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, United States
Emory University
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Atlanta Institute for Medical Research
Decatur, Georgia, United States
Kootenai Heart Clinics, LLC
Coeur d'Alene, Idaho, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Edward Hines VA Hospital
Hines, Illinois, United States
St Vincent Medical Group
Indianapolis, Indiana, 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
Research Concierge, LLC
Hartford, Kentucky, United States
Kentucky Lung Clinic
Hazard, Kentucky, United States
Jewish Hospital & St Mary's Healthcare
Louisville, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Louisiana State University Health Science Center
Shreveport, Louisiana, 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
Johns Hopkins University Hospital
Baltimore, Maryland, United States
Activmed Practices & Research, Inc
Methuen, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
McLaren-Flint Research Institute
Flint, Michigan, United States
St John Hospital & Medical Center
Grosse Pointe Woods, Michigan, United States
Bronson Healthcare Group
Kalamazoo, Michigan, United States
Crittenton Hospital Medical Center
Rochester Hills, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
HealthEast St Joseph's Hospital
Saint Paul, Minnesota, United States
David M Headley
Port Gibson, Mississippi, United States
St Anthony's Medical Center
St Louis, Missouri, United States
Alegent Creighton Health Heart & Vascular Specialists
Omaha, Nebraska, United States
Creighton University
Omaha, Nebraska, United States
eStudySite, Las Vegas
Las Vegas, Nevada, United States
VA Sierra Nevada Health Care System
Reno, Nevada, United States
Hunterdon Cardiovascular Associates
Flemington, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Virtua Medical Group
Moorestown, New Jersey, United States
Associated Cardiovascular Consultants of Lourdes
Voorhees Township, New Jersey, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Erie County Medical Center
Buffalo, New York, 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
Novant Clinical Research Institute
Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Sanford Clinic North-Fargo
Fargo, North Dakota, United States
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, 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
The Reading Hospital and Medical Center
West Reading, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute, Inc.
Wormleysburg, Pennsylvania, United States
PMG research of Charleston
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Palmetto Senior Primary Care Practice
Columbia, South Carolina, United States
Sanford Clinic Family Medicine
Sioux Falls, South Dakota, United States
STHS Heart, LLC
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas A&M University
College Station, Texas, United States
Advanced Clinical Research Associates
Plano, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
Sonterra Clinical Research
San Antonio, Texas, United States
Sonterra Clinical Research
San Antonio, Texas, United States
Tanner Clinic
Layton, Utah, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Carilion Medical Center Geriatrics
Roanoke, Virginia, United States
Salem VA Medical Center
Salem, 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
Mayagüez, , Puerto Rico
Research and Cardiovascular Corp
Ponce, , Puerto Rico
VA Caribbean Healthcare System
San Juan, , Puerto Rico
Countries
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References
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Baggs GE, Middleton C, Nelson JL, Pereira SL, Hegazi RM, Matarese L, Matheson E, Ziegler TR, Tappenden KA, Deutz N. Impact of a specialized oral nutritional supplement on quality of life in older adults following hospitalization: Post-hoc analysis of the NOURISH trial. Clin Nutr. 2023 Nov;42(11):2116-2123. doi: 10.1016/j.clnu.2023.09.004. Epub 2023 Sep 9.
Matheson EM, Nelson JL, Baggs GE, Luo M, Deutz NE. Specialized oral nutritional supplement (ONS) improves handgrip strength in hospitalized, malnourished older patients with cardiovascular and pulmonary disease: A randomized clinical trial. Clin Nutr. 2021 Mar;40(3):844-849. doi: 10.1016/j.clnu.2020.08.035. Epub 2020 Sep 5.
Deutz NE, Matheson EM, Matarese LE, Luo M, Baggs GE, Nelson JL, Hegazi RA, Tappenden KA, Ziegler TR; NOURISH Study Group. Readmission and mortality in malnourished, older, hospitalized adults treated with a specialized oral nutritional supplement: A randomized clinical trial. Clin Nutr. 2016 Feb;35(1):18-26. doi: 10.1016/j.clnu.2015.12.010. Epub 2016 Jan 18.
Other Identifiers
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BL01
Identifier Type: -
Identifier Source: org_study_id
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