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OpenTrials
Completed

NCT Number: NCT01626742

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

San Juan Bautista School of Medicine, Caguas, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Uncontrolled hypertension
  • Diagnosis of diabetes
  • Current active cancer or recently treated cancer
  • Impaired renal function
  • Liver failure, acute Hepatitis, or hepatic encephalopathy
  • Active tuberculosis.
  • 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.

Treatment and study plan

Ready to Drink Flavored Beverage

Other

2 servings a day

Ready to drink flavored beverage w/ AN 777

Other

2 servings a day

Primary outcomes

  1. Return to hospital or death

    Time frame: 90 days

Secondary outcomes

  1. Return to hospital or death

    Time frame: 30 and 60 days

  2. Hospital Days

    Time frame: 90 days

  3. Activities of Daily Living

    Time frame: 90 days

    Katz Activities of Daily Living at entry and 90 days

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 25, 2012
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.