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

A Randomized Double Blinded Controlled Trial of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients

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.

Study Overview

• Status: Completed
• Conditions: Hospitalized Elderly
• Intervention / Treatment: Other: Ready to Drink Flavored Beverage; Other: Ready to drink flavored beverage w/ AN 777

• Study Type: Interventional
• Enrollment (Actual): 652
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Caguas, Puerto Rico, 00725
    • San Juan Bautista School of Medicine
  • Mayaguez, Puerto Rico, 00680
    • Western Cardiovascular Surgery of Puerto Rico
  • Ponce, Puerto Rico, 00717
    • Research and Cardiovascular Corp
  • San Juan, Puerto Rico, 00921
    • VA Caribbean Healthcare System
• United States
  • Alabama
    • Auburn, Alabama, United States, 36849
      • Auburn University
    • Birmingham, Alabama, United States, 35235
      • Birmingham Heart Clinic
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research, LLC
    • Montgomery, Alabama, United States, 36106
      • Healthscan Research
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Scottsdale Healthcare
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research
  • California
    • Fresno, California, United States, 93701
      • UCSF Fresno
    • Fullerton, California, United States, 92835
      • St. Jude Medical Center
    • Glendale, California, United States, 91206
      • Glendale Adventist Medical Center
    • La Mesa, California, United States, 91942
      • eStudySite, La Mesa
    • Laguna Hills, California, United States, 92653
      • South Orange County Surgical Medical Group
    • Modesto, California, United States, 95350
      • Novo Research dba FCPP Research
    • Oceanside, California, United States, 92056
      • eStudySite, Oceanside
    • Orange, California, United States, 92868
      • Pulmonary Consultant & Primary Physicians Medical Group
    • Torrance, California, United States, 90502
      • Los Angeles Biomedical Research Institution
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Aurora Denver Cardiology Associates, PC
    • Loveland,, Colorado, United States, 80538
      • Medical Center of the Rockies
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • UCONN Health Center
  • Florida
    • Atlantis, Florida, United States, 33462
      • Zasa Clinical Research
    • Boynton Beach, Florida, United States, 33472
      • Visions Clinical Research, LLC
    • Brandon, Florida, United States, 33511
      • Pulmonary and Sleep of Tampa Bay
    • Clearwater, Florida, United States, 33756
      • Morton Plant Mease Healthcare
    • Delray Beach, Florida, United States, 33484
      • Seidman Clinical Trials
    • Ft. Lauderdale, Florida, United States, 33316
      • Broward Health - Broward General Medical Center
    • Gainesville, Florida, United States, 32611
      • University of Florida
    • Hialeah, Florida, United States, 33010
      • In Vivo Clinical Research
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Jacksonville, Florida, United States, 32207
      • River City Clinical Research
    • Lake Mary, Florida, United States, 32746
      • The Cardiovascular Center, P.A.
    • Lakeland, Florida, United States, 33805
      • Watson Clinic Center for Research, Inc.
    • Largo, Florida, United States, 33770
      • Largo Medical Center
    • Lynn Haven, Florida, United States, 32444
      • Panama Clinical Research Associates
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine
    • Miami, Florida, United States, 33173
      • Health & Life Research Solutions Inc.
    • Miami, Florida, United States, 33143
      • Cuervo Clinical Research Group, Inc
    • Ocala, Florida, United States, 34471
      • Ocala Research Institute, Inc.
    • Panama City, Florida, United States, 32401
      • Cardiovascular Institute of Northwest Florida
    • Pensacola, Florida, United States, 32501
      • Cardiology Consultants
    • South Miami, Florida, United States, 33143
      • Regenerate Clinical Trials
    • Stuart, Florida, United States, 34996
      • Advanced Clinical Research Group
    • Wellington, Florida, United States, 33449
      • Cardiology Partners Clinical Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30303
      • Emory University
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
    • Decatur, Georgia, United States, 30030
      • Atlanta Institute for Medical Research
  • Idaho
    • Coeur d' Alene, Idaho, United States, 83814
      • Kootenai Heart Clinics, LLC
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60641
      • University of Illinois at Chicago
    • Hines, Illinois, United States, 60141
      • Edward Hines VA Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St Vincent Medical Group
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • King's Daughters Medical Center, Kentucky Heart Foundation , Inc.
    • Hartford, Kentucky, United States, 42347
      • Research Concierge, LLC
    • Hazard, Kentucky, United States, 41701
      • Kentucky Lung Clinic
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital & St Mary's Healthcare
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
    • Shreveport, Louisiana, United States, 71103
      • Louisiana State University Health Science Center
  • Maine
    • Auburn, Maine, United States, 04210
      • Maine Research Associates
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University Hospital
    • Baltimore, Maryland, United States, 21218
      • MedStar Health Research Institute - MedStar Union Memorial Hospital
  • Massachusetts
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices & Research, Inc
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Flint, Michigan, United States, 48532
      • McLaren-Flint Research Institute
    • Grosse Pointe Woods, Michigan, United States, 48236
      • St John Hospital & Medical Center
    • Kalamazoo, Michigan, United States, 49007
      • Bronson Healthcare Group
    • Rochester Hills, Michigan, United States, 48307
      • Crittenton Hospital Medical Center
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • St. Paul, Minnesota, United States, 55102
      • HealthEast St Joseph's Hospital
  • Mississippi
    • Port Gibson, Mississippi, United States, 39150
      • David M Headley
  • Missouri
    • St. Louis, Missouri, United States, 63128
      • St Anthony's Medical Center
  • Nebraska
    • Omaha, Nebraska, United States, 68178
      • Creighton University
    • Omaha, Nebraska, United States, 68124
      • Alegent Creighton Health Heart & Vascular Specialists
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • eStudySite, Las Vegas
    • Reno, Nevada, United States, 89502
      • VA Sierra Nevada Health Care System
  • New Jersey
    • Flemington, New Jersey, United States, 08822
      • Hunterdon Cardiovascular Associates
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Moorestown, New Jersey, United States, 08057
      • Virtua Medical Group
    • Voorhees, New Jersey, United States, 08043
      • Associated Cardiovascular Consultants of Lourdes
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Health Sciences Center
  • New York
    • Buffalo, New York, United States, 14215
      • Erie County Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
    • Winston Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Clinical Research Institute
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Sanford Clinic North-Fargo
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Elyria, Ohio, United States, 44035
      • North Ohio Research
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Hospital
    • Ephrata, Pennsylvania, United States, 17522
      • Physician Specialists of Northern Lancaster County Medical Group
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine
    • Sayre, Pennsylvania, United States, 18840
      • Donald Guthrie Foundation for Education and Research, Inc.
    • Sellersville, Pennsylvania, United States, 18960
      • Grand View Hospital Clinical Research
    • West Reading, Pennsylvania, United States, 19611
      • The Reading Hospital and Medical Center
    • Wormleysburg, Pennsylvania, United States, 17043
      • Pinnacle Health Cardiovascular Institute, INC.
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29407
      • PMG Research of Charleston
    • Columbia, South Carolina, United States, 29203
      • Palmetto Senior Primary Care Practice
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57106
      • Sanford Clinic Family Medicine
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37205
      • STHS Heart, LLC
  • Texas
    • College Station, Texas, United States, 77843
      • Texas A&M University
    • Plano, Texas, United States, 75093
      • Advanced Clinical Research Associates
    • San Antonio, Texas, United States, 78201
      • South Texas Cardiovascular Consultants
    • San Antonio, Texas, United States, 78258
      • Sonterra Clinical Research
    • San Antonio, Texas, United States, 78205
      • Sonterra Clinical Research
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Clinic
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Cardiovascular Research Institute
    • Roanoke, Virginia, United States, 24014
      • Carilion Medical Center Geriatrics
    • Salem, Virginia, United States, 24153
      • Salem VA Medical Center
  • Washington
    • Bellevue, Washington, United States, 98004
      • The Hope Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Ready to drink flavored beverage	Other: Ready to Drink Flavored Beverage; 2 servings a day
Experimental: Ready to drink flavored beverage w/ AN 777	Other: Ready to drink flavored beverage w/ AN 777; 2 servings a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Return to hospital or death	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to hospital or death		30 and 60 days
Hospital Days		90 days
Activities of Daily Living	Katz Activities of Daily Living at entry and 90 days	90 days

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Jeffrey Nelson, PhD, Abbott Nutrition; Study Chair: Menghua Luo, MD, PhD, Abbott Nutrition

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: June 21, 2012
• First Submitted That Met QC Criteria: June 21, 2012
• First Posted (Estimate): June 25, 2012

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 24, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: BL01