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

April 24, 2015 updated by: Abbott Nutrition

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
652

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Return to hospital or death
Time Frame: 90 days
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Return to hospital or death
Time Frame: 30 and 60 days
30 and 60 days
Hospital Days
Time Frame: 90 days
90 days
Activities of Daily Living
Time Frame: 90 days
Katz Activities of Daily Living at entry and 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jeffrey Nelson, PhD, Abbott Nutrition
  • Study Chair: Menghua Luo, MD, PhD, Abbott Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BL01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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