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Hospitalized ElderlyPhase 3NCT01626742

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

A Phase 3 study testing Ready to Drink Flavored Beverage and Ready to drink flavored beverage w/ AN 777 in people with Hospitalized Elderly, run by Abbott Nutrition at 119 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Hospitalized Elderly
What is being tested?
Ready to Drink Flavored Beverage and Ready to drink flavored beverage w/ AN 777
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
652 participants
Where
119 sitesin 2 countries
Study dates
May 2012to Oct 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Male or female ≥ 65 years of age.
  • Admitted to hospital with diagnosis of heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease.
  • Subjective Global Assessment rating of B or C.
  • Length of hospital stay anticipated to be > 3 days and < 12 days
  • Able to consume foods and beverages orally.
  • Functionally ambulatory during the 30 days prior to admission.

Who cannot join

  • Uncontrolled hypertension
  • Diagnosis of diabetes
  • Current active cancer or recently treated cancer
  • Impaired renal function
  • Liver failure, acute Hepatitis, or hepatic encephalopathy
  • Active tuberculosis.
Show all 15Show fewer
  • HIV
  • Disorder of gastrointestinal tract
  • Autoimmune disorder
  • Intubation, and/or tube or parenteral feeding.
  • 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
  • Allergy or intolerance to any of the ingredients in the study products.
  • Body mass index of ≥ 40 kg/m2.
  • Resident in a nursing home or other residential facility.
  • Planned surgery during course of the study.

Trial locations and contacts

119 sites in 2 countries.

119 sites in 2 countries

United States115 sites

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87131

  • Mission Hospital

    Asheville, North Carolina, 28801

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

    Ashland, Kentucky, 41101

  • Emory University

    Atlanta, Georgia, 30303

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • ZASA Clinical Research

    Atlantis, Florida, 33462

  • Auburn University

    Auburn, Alabama, 36849

  • Maine Research Associates

    Auburn, Maine, 04210

  • Aurora Denver Cardiology Associates, PC

    Aurora, Colorado, 80012

  • MedStar Health Research Institute - MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Johns Hopkins University Hospital

    Baltimore, Maryland, 21287

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • The Hope Heart Institute

    Bellevue, Washington, 98004

  • Birmingham Heart Clinic

    Birmingham, Alabama, 35235

  • Visions Clinical Research, LLC

    Boynton Beach, Florida, 33472

  • Pulmonary and Sleep of Tampa Bay

    Brandon, Florida, 33511

  • Erie County Medical Center

    Buffalo, New York, 14215

  • PMG research of Charleston

    Charleston, South Carolina, 29407

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Illinois at Chicago

    Chicago, Illinois, 60641

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

    Cincinnati, Ohio, 45219

  • Morton Plant Mease HealthCare

    Clearwater, Florida, 33756

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Kootenai Heart Clinics, LLC

    Coeur d'Alene, Idaho, 83814

  • Texas A&M University

    College Station, Texas, 77843

  • Palmetto Senior Primary Care Practice

    Columbia, South Carolina, 29203

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Atlanta Institute for Medical Research

    Decatur, Georgia, 30030

  • Seidman Clinical Trials

    Delray Beach, Florida, 33484

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • North Ohio Research

    Elyria, Ohio, 44035

  • Physician Specialists of Northern Lancaster County Medical Group

    Ephrata, Pennsylvania, 17522

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58122

  • UConn Health Center

    Farmington, Connecticut, 06030

  • Hunterdon Cardiovascular Associates

    Flemington, New Jersey, 08822

  • McLaren-Flint Research Institute

    Flint, Michigan, 48532

  • Broward Health - Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • UCSF Fresno

    Fresno, California, 93701

  • St. Jude Medical Center

    Fullerton, California, 92835

  • University of Florida

    Gainesville, Florida, 32611

  • Glendale Adventist Medical Center

    Glendale, California, 91206

  • East Carolina University

    Greenville, North Carolina, 27834

  • St John Hospital & Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Research Concierge, LLC

    Hartford, Kentucky, 42347

  • Kentucky Lung Clinic

    Hazard, Kentucky, 41701

  • In Vivo Clinical Research

    Hialeah, Florida, 33010

  • Edward Hines VA Hospital

    Hines, Illinois, 60141

  • Heart Center Research, LLC

    Huntsville, Alabama, 35801

  • St Vincent Medical Group

    Indianapolis, Indiana, 46290

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • River City Clinical Research

    Jacksonville, Florida, 32207

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Bronson Healthcare Group

    Kalamazoo, Michigan, 49007

  • eStudySite, La Mesa

    La Mesa, California, 91942

  • South Orange County Surgical Medical Group

    Laguna Hills, California, 92653

  • The Cardiovascular Center, P.A.

    Lake Mary, Florida, 32746

  • Watson Clinic Center for Research, Inc.

    Lakeland, Florida, 33805

  • Largo Medical Center

    Largo, Florida, 33770

  • eStudySite, Las Vegas

    Las Vegas, Nevada, 89109

  • Tanner Clinic

    Layton, Utah, 84041

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205

  • Jewish Hospital & St Mary's Healthcare

    Louisville, Kentucky, 40202

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Panama Clinical Research Associates

    Lynn Haven, Florida, 32444

  • Activmed Practices & Research, Inc

    Methuen, Massachusetts, 01844

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • Cuervo Clinical Research Group, Inc

    Miami, Florida, 33143

  • Health & Life Research Solutions Inc.

    Miami, Florida, 33173

  • Novo Research dba FCPP Research

    Modesto, California, 95350

  • HealthScan Research

    Montgomery, Alabama, 36106

  • Virtua Medical Group

    Moorestown, New Jersey, 08057

  • STHS Heart, LLC

    Nashville, Tennessee, 37205

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10032

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507

  • Ocala Research Institute, Inc.

    Ocala, Florida, 34471

  • eStudySite, Oceanside

    Oceanside, California, 92056

  • Alegent Creighton Health Heart & Vascular Specialists

    Omaha, Nebraska, 68124

  • Creighton University

    Omaha, Nebraska, 68178

  • Pulmonary Consultant & Primary Physicians Medical Group

    Orange, California, 92868

  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida, 32401

  • Cardiology Consultants

    Pensacola, Florida, 32501

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Advanced Clinical Research Associates

    Plano, Texas, 75093

  • David M Headley

    Port Gibson, Mississippi, 39150

  • VA Sierra Nevada Health Care System

    Reno, Nevada, 89502

  • Carilion Medical Center Geriatrics

    Roanoke, Virginia, 24014

  • Rochester General Hospital

    Rochester, New York, 14621

  • Crittenton Hospital Medical Center

    Rochester Hills, Michigan, 48307

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • HealthEast St Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • Salem VA Medical Center

    Salem, Virginia, 24153

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78201

  • Sonterra Clinical Research

    San Antonio, Texas, 78205

  • Sonterra Clinical Research

    San Antonio, Texas, 78258

  • Donald Guthrie Foundation for Education and Research, Inc.

    Sayre, Pennsylvania, 18840

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85260

  • Grand View Hospital Clinical Research

    Sellersville, Pennsylvania, 18960

  • Louisiana State University Health Science Center

    Shreveport, Louisiana, 71103

  • Sanford Clinic Family Medicine

    Sioux Falls, South Dakota, 57106

  • Regenerate Clinical Trials

    South Miami, Florida, 33143

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • St Anthony's Medical Center

    St Louis, Missouri, 63128

  • Advanced Clinical Research Group

    Stuart, Florida, 34996

  • Los Angeles Biomedical Research Institution

    Torrance, California, 90502

  • Associated Cardiovascular Consultants of Lourdes

    Voorhees Township, New Jersey, 08043

  • Cardiology Partners Clinical Research Institute

    Wellington, Florida, 33449

  • The Reading Hospital and Medical Center

    West Reading, Pennsylvania, 19611

  • Novant Clinical Research Institute

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Pinnacle Health Cardiovascular Institute, Inc.

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

Puerto Rico4 sites

  • San Juan Bautista School of Medicine

    Caguas, 00725

  • Western Cardiovascular Surgery of Puerto Rico

    Mayagüez, 00680

  • Research and Cardiovascular Corp

    Ponce, 00717

  • VA Caribbean Healthcare System

    San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Ready to Drink Flavored Beverage, Ready to drink flavored beverage w/ AN 777

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ready to Drink Flavored BeverageOther

    2 servings a day

  • Ready to drink flavored beverage w/ AN 777Other

    2 servings a day

Study groups in NCT01626742
Study groupRoleWhat they receive
Ready to drink flavored beveragePlacebo comparatorNot described
Receives: Other: Ready to Drink Flavored Beverage
Ready to drink flavored beverage w/ AN 777ExperimentalNot described
Receives: Other: Ready to drink flavored beverage w/ AN 777

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Return to hospital or death

    Measured: 90 days

Secondary outcomes (3)

  1. Return to hospital or death

    Measured: 30 and 60 days

  2. Hospital Days

    Measured: 90 days

  3. Activities of Daily Living

    Katz Activities of Daily Living at entry and 90 days

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
652 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01626742
Sponsor's protocol ID
BL01
Status last verified
Apr 2015
First submitted
21 Jun 2012
Last updated
28 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37757502

  • 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.

    PubMed 32943241

  • 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.

    PubMed 26797412

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ready to Drink Flavored Beverage and Ready to drink flavored beverage w/ AN 777 in people with Hospitalized Elderly, run by Abbott Nutrition at 119 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Return to hospital or death (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01626742, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.

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