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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01626742
First received: June 21, 2012
Last updated: April 24, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Hospitalized Elderly
Other: Ready to Drink Flavored Beverage
Other: Ready to drink flavored beverage w/ AN 777
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double Blinded Controlled Trial of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Return to hospital or death [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Return to hospital or death [ Time Frame: 30 and 60 days ] [ Designated as safety issue: No ]
  • Hospital Days [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Activities of Daily Living [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Katz Activities of Daily Living at entry and 90 days


Enrollment: 652
Study Start Date: May 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626742

  Show 119 Study Locations
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Menghua Luo, MD, PhD Abbott Nutrition
Study Chair: Jeffrey Nelson, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01626742     History of Changes
Other Study ID Numbers: BL01
Study First Received: June 21, 2012
Last Updated: April 24, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 29, 2015