Clinical trial NCT01626742: A Trial of an Oral Nutritional Supplement in Older Hospitalized Patients - NOURISH Study
Official title: A Randomized Double Blinded Controlled Trial of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hospitalized Elderly
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2012-06-25
Enrollment: 652
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Return to hospital or death
timeFrame: 90 days
Secondary outcomes:
measure: Return to hospital or death
timeFrame: 30 and 60 days
measure: Hospital Days
timeFrame: 90 days
measure: Activities of Daily Living
timeFrame: 90 days
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
city: Birmingham
country: United States
facility: Birmingham Heart Clinic
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Montgomery
country: United States
facility: HealthScan Research
state: Alabama
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Fresno
country: United States
facility: UCSF Fresno
state: California
city: Fullerton
country: United States
facility: St. Jude Medical Center
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: La Mesa
country: United States
facility: eStudySite, La Mesa
state: California
city: Laguna Hills
country: United States
facility: South Orange County Surgical Medical Group
state: California
city: Modesto
country: United States
facility: Novo Research dba FCPP Research
state: California
city: Oceanside
country: United States
facility: eStudySite, Oceanside
state: California
city: Orange
country: United States
facility: Pulmonary Consultant & Primary Physicians Medical Group
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institution
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates, PC
state: Colorado
city: Loveland,
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Farmington
country: United States
facility: UConn Health Center
state: Connecticut
city: Atlantis
country: United States
facility: ZASA Clinical Research
state: Florida
city: Boynton Beach
country: United States
facility: Visions Clinical Research, LLC
state: Florida
city: Brandon
country: United States
facility: Pulmonary and Sleep of Tampa Bay
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Mease HealthCare
state: Florida
city: Delray Beach
country: United States
facility: Seidman Clinical Trials
state: Florida
city: Ft. Lauderdale
country: United States
facility: Broward Health - Broward General Medical Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hialeah
country: United States
facility: In Vivo Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: River City Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Lake Mary
country: United States
facility: The Cardiovascular Center, P.A.
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Research, Inc.
state: Florida
city: Largo
country: United States
facility: Largo Medical Center
state: Florida
city: Lynn Haven
country: United States
facility: Panama Clinical Research Associates
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Miami
country: United States
facility: Cuervo Clinical Research Group, Inc
state: Florida
city: Miami
country: United States
facility: Health & Life Research Solutions Inc.
state: Florida
city: Ocala
country: United States
facility: Ocala Research Institute, Inc.
state: Florida
city: Panama City
country: United States
facility: Cardiovascular Institute of Northwest Florida
state: Florida
city: Pensacola
country: United States
facility: Cardiology Consultants
state: Florida
city: South Miami
country: United States
facility: Regenerate Clinical Trials
state: Florida
city: Stuart
country: United States
facility: Advanced Clinical Research Group
state: Florida
city: Wellington
country: United States
facility: Cardiology Partners Clinical Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Decatur
country: United States
facility: Atlanta Institute for Medical Research
state: Georgia
city: Coeur d' Alene
country: United States
facility: Kootenai Heart Clinics, LLC
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Hines
country: United States
facility: Edward Hines VA Hospital
state: Illinois
city: Indianapolis
country: United States
facility: St Vincent Medical Group
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Ashland
country: United States
facility: King's Daughters Medical Center, Kentucky Heart Foundation , Inc.
state: Kentucky
city: Hartford
country: United States
facility: Research Concierge, LLC
state: Kentucky
city: Hazard
country: United States
facility: Kentucky Lung Clinic
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital & St Mary's Healthcare
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Science Center
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: MedStar Health Research Institute - MedStar Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University Hospital
state: Maryland
city: Methuen
country: United States
facility: Activmed Practices & Research, Inc
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Flint
country: United States
facility: McLaren-Flint Research Institute
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: St John Hospital & Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Healthcare Group
state: Michigan
city: Rochester Hills
country: United States
facility: Crittenton Hospital Medical Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: St. Paul
country: United States
facility: HealthEast St Joseph's Hospital
state: Minnesota
city: Port Gibson
country: United States
facility: David M Headley
state: Mississippi
city: St. Louis
country: United States
facility: St Anthony's Medical Center
state: Missouri
city: Omaha
country: United States
facility: Alegent Creighton Health Heart & Vascular Specialists
state: Nebraska
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Las Vegas
country: United States
facility: eStudySite, Las Vegas
state: Nevada
city: Reno
country: United States
facility: VA Sierra Nevada Health Care System
state: Nevada
city: Flemington
country: United States
facility: Hunterdon Cardiovascular Associates
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Moorestown
country: United States
facility: Virtua Medical Group
state: New Jersey
city: Voorhees
country: United States
facility: Associated Cardiovascular Consultants of Lourdes
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Winston Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Clinical Research Institute
state: North Carolina
city: Fargo
country: United States
facility: Sanford Clinic North-Fargo
state: North Dakota
city: Cincinnati
country: United States
facility: The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Elyria
country: United States
facility: North Ohio Research
state: Ohio
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Ephrata
country: United States
facility: Physician Specialists of Northern Lancaster County Medical Group
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education and Research, Inc.
state: Pennsylvania
city: Sellersville
country: United States
facility: Grand View Hospital Clinical Research
state: Pennsylvania
city: West Reading
country: United States
facility: The Reading Hospital and Medical Center
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute, Inc.
state: Pennsylvania
city: Charleston
country: United States
facility: PMG research of Charleston
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Palmetto Senior Primary Care Practice
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Clinic Family Medicine
state: South Dakota
city: Nashville
country: United States
facility: STHS Heart, LLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: College Station
country: United States
facility: Texas A&M University
state: Texas
city: Plano
country: United States
facility: Advanced Clinical Research Associates
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: San Antonio
country: United States
facility: Sonterra Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Sonterra Clinical Research
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
city: Roanoke
country: United States
facility: Carilion Medical Center Geriatrics
state: Virginia
city: Salem
country: United States
facility: Salem VA Medical Center
state: Virginia
city: Bellevue
country: United States
facility: The Hope Heart Institute
state: Washington
city: Caguas
country: Puerto Rico
facility: San Juan Bautista School of Medicine
city: Mayaguez
country: Puerto Rico
facility: Western Cardiovascular Surgery of Puerto Rico
city: Ponce
country: Puerto Rico
facility: Research and Cardiovascular Corp
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System
Study officials:
affiliation: Abbott Nutrition
name: Menghua Luo, MD, PhD
role: STUDY_CHAIR
affiliation: Abbott Nutrition
name: Jeffrey Nelson, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.