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

NCT ID: NCT01626742

Last Updated: 2015-04-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-10-31

Brief Summary

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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

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Conditions

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Hospitalized Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ready to drink flavored beverage

Group Type PLACEBO_COMPARATOR

Ready to Drink Flavored Beverage

Intervention Type OTHER

2 servings a day

Ready to drink flavored beverage w/ AN 777

Group Type EXPERIMENTAL

Ready to drink flavored beverage w/ AN 777

Intervention Type OTHER

2 servings a day

Interventions

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Ready to Drink Flavored Beverage

2 servings a day

Intervention Type OTHER

Ready to drink flavored beverage w/ AN 777

2 servings a day

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Birmingham Heart Clinic

Birmingham, Alabama, United States

Site Status

Heart Center Research, LLC

Huntsville, Alabama, United States

Site Status

HealthScan Research

Montgomery, Alabama, United States

Site Status

Scottsdale Healthcare

Scottsdale, Arizona, United States

Site Status

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

Site Status

UCSF Fresno

Fresno, California, United States

Site Status

St. Jude Medical Center

Fullerton, California, United States

Site Status

Glendale Adventist Medical Center

Glendale, California, United States

Site Status

eStudySite, La Mesa

La Mesa, California, United States

Site Status

South Orange County Surgical Medical Group

Laguna Hills, California, United States

Site Status

Novo Research dba FCPP Research

Modesto, California, United States

Site Status

eStudySite, Oceanside

Oceanside, California, United States

Site Status

Pulmonary Consultant & Primary Physicians Medical Group

Orange, California, United States

Site Status

Los Angeles Biomedical Research Institution

Torrance, California, United States

Site Status

Aurora Denver Cardiology Associates, PC

Aurora, Colorado, United States

Site Status

Medical Center of the Rockies

Loveland, Colorado, United States

Site Status

UConn Health Center

Farmington, Connecticut, United States

Site Status

ZASA Clinical Research

Atlantis, Florida, United States

Site Status

Visions Clinical Research, LLC

Boynton Beach, Florida, United States

Site Status

Pulmonary and Sleep of Tampa Bay

Brandon, Florida, United States

Site Status

Morton Plant Mease HealthCare

Clearwater, Florida, United States

Site Status

Seidman Clinical Trials

Delray Beach, Florida, United States

Site Status

Broward Health - Broward General Medical Center

Fort Lauderdale, Florida, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

In Vivo Clinical Research

Hialeah, Florida, United States

Site Status

River City Clinical Research

Jacksonville, Florida, United States

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

The Cardiovascular Center, P.A.

Lake Mary, Florida, United States

Site Status

Watson Clinic Center for Research, Inc.

Lakeland, Florida, United States

Site Status

Largo Medical Center

Largo, Florida, United States

Site Status

Panama Clinical Research Associates

Lynn Haven, Florida, United States

Site Status

University of Miami Miller School of Medicine

Miami, Florida, United States

Site Status

Cuervo Clinical Research Group, Inc

Miami, Florida, United States

Site Status

Health & Life Research Solutions Inc.

Miami, Florida, United States

Site Status

Ocala Research Institute, Inc.

Ocala, Florida, United States

Site Status

Cardiovascular Institute of Northwest Florida

Panama City, Florida, United States

Site Status

Cardiology Consultants

Pensacola, Florida, United States

Site Status

Regenerate Clinical Trials

South Miami, Florida, United States

Site Status

Advanced Clinical Research Group

Stuart, Florida, United States

Site Status

Cardiology Partners Clinical Research Institute

Wellington, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Columbus Regional Research Institute

Columbus, Georgia, United States

Site Status

Atlanta Institute for Medical Research

Decatur, Georgia, United States

Site Status

Kootenai Heart Clinics, LLC

Coeur d'Alene, Idaho, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Edward Hines VA Hospital

Hines, Illinois, United States

Site Status

St Vincent Medical Group

Indianapolis, Indiana, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

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

Ashland, Kentucky, United States

Site Status

Research Concierge, LLC

Hartford, Kentucky, United States

Site Status

Kentucky Lung Clinic

Hazard, Kentucky, United States

Site Status

Jewish Hospital & St Mary's Healthcare

Louisville, Kentucky, United States

Site Status

Ochsner Medical Center

New Orleans, Louisiana, United States

Site Status

Louisiana State University Health Science Center

Shreveport, Louisiana, United States

Site Status

Maine Research Associates

Auburn, Maine, United States

Site Status

Eastern Maine Medical Center

Bangor, Maine, United States

Site Status

MedStar Health Research Institute - MedStar Union Memorial Hospital

Baltimore, Maryland, United States

Site Status

Johns Hopkins University Hospital

Baltimore, Maryland, United States

Site Status

Activmed Practices & Research, Inc

Methuen, Massachusetts, United States

Site Status

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status

McLaren-Flint Research Institute

Flint, Michigan, United States

Site Status

St John Hospital & Medical Center

Grosse Pointe Woods, Michigan, United States

Site Status

Bronson Healthcare Group

Kalamazoo, Michigan, United States

Site Status

Crittenton Hospital Medical Center

Rochester Hills, Michigan, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

HealthEast St Joseph's Hospital

Saint Paul, Minnesota, United States

Site Status

David M Headley

Port Gibson, Mississippi, United States

Site Status

St Anthony's Medical Center

St Louis, Missouri, United States

Site Status

Alegent Creighton Health Heart & Vascular Specialists

Omaha, Nebraska, United States

Site Status

Creighton University

Omaha, Nebraska, United States

Site Status

eStudySite, Las Vegas

Las Vegas, Nevada, United States

Site Status

VA Sierra Nevada Health Care System

Reno, Nevada, United States

Site Status

Hunterdon Cardiovascular Associates

Flemington, New Jersey, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Virtua Medical Group

Moorestown, New Jersey, United States

Site Status

Associated Cardiovascular Consultants of Lourdes

Voorhees Township, New Jersey, United States

Site Status

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

Site Status

Erie County Medical Center

Buffalo, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Rochester General Hospital

Rochester, New York, United States

Site Status

Mission Hospital

Asheville, North Carolina, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

Novant Clinical Research Institute

Winston-Salem, North Carolina, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Sanford Clinic North-Fargo

Fargo, North Dakota, United States

Site Status

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

Cincinnati, Ohio, United States

Site Status

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

North Ohio Research

Elyria, Ohio, United States

Site Status

Doylestown Hospital

Doylestown, Pennsylvania, United States

Site Status

Physician Specialists of Northern Lancaster County Medical Group

Ephrata, Pennsylvania, United States

Site Status

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Donald Guthrie Foundation for Education and Research, Inc.

Sayre, Pennsylvania, United States

Site Status

Grand View Hospital Clinical Research

Sellersville, Pennsylvania, United States

Site Status

The Reading Hospital and Medical Center

West Reading, Pennsylvania, United States

Site Status

Pinnacle Health Cardiovascular Institute, Inc.

Wormleysburg, Pennsylvania, United States

Site Status

PMG research of Charleston

Charleston, South Carolina, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Palmetto Senior Primary Care Practice

Columbia, South Carolina, United States

Site Status

Sanford Clinic Family Medicine

Sioux Falls, South Dakota, United States

Site Status

STHS Heart, LLC

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Texas A&M University

College Station, Texas, United States

Site Status

Advanced Clinical Research Associates

Plano, Texas, United States

Site Status

South Texas Cardiovascular Consultants

San Antonio, Texas, United States

Site Status

Sonterra Clinical Research

San Antonio, Texas, United States

Site Status

Sonterra Clinical Research

San Antonio, Texas, United States

Site Status

Tanner Clinic

Layton, Utah, United States

Site Status

Sentara Cardiovascular Research Institute

Norfolk, Virginia, United States

Site Status

Carilion Medical Center Geriatrics

Roanoke, Virginia, United States

Site Status

Salem VA Medical Center

Salem, Virginia, United States

Site Status

The Hope Heart Institute

Bellevue, Washington, United States

Site Status

San Juan Bautista School of Medicine

Caguas, , Puerto Rico

Site Status

Western Cardiovascular Surgery of Puerto Rico

Mayagüez, , Puerto Rico

Site Status

Research and Cardiovascular Corp

Ponce, , Puerto Rico

Site Status

VA Caribbean Healthcare System

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

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.

Reference Type DERIVED
PMID: 37757502 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32943241 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26797412 (View on PubMed)

Other Identifiers

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BL01

Identifier Type: -

Identifier Source: org_study_id

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