Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01477723
First received: November 19, 2011
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

Study objectives are to verify the loss of lean mass during a hospital stay in a group of older patients; to evaluate the effects of consuming a high-calorie complete and balanced oral nutritional supplement; to collect post-discharge information.


Condition Intervention Phase
Pneumonia
Other: Experimental Oral Nutritional Supplement
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation 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:
  • Leg Lean Mass [ Time Frame: baseline to day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body Weight [ Time Frame: baseline to day 30 ] [ Designated as safety issue: No ]
  • Body Mass Index [ Time Frame: baseline to day 30 ] [ Designated as safety issue: No ]
  • Activities of daily living [ Time Frame: baseline to day 30 ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: October 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Oral Nutrition Supplement
Experimental ONS orally Two 8 fl oz servings/day
Other: Experimental Oral Nutritional Supplement
Experimental ONS orally Two 8 fl oz servings/day
No Intervention: No Product

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥ 55 years of age.
  2. Admitted to hospital with a disease of respiratory system including acute respiratory diseases (e.g., pneumonia, acute bronchitis) or exacerbation of existing respiratory diseases.
  3. Anticipated length of hospital stay of at least 3 days.
  4. Ability to climb a flight of 10 stairs or walk a city block without the help of another person prior to hospitalization.
  5. Able to consume foods and beverages orally.

Exclusion Criteria:

  1. Unstable heart failure which requires ICU admission.
  2. Severe respiratory disease requiring long-term, continuous oxygen therapy.
  3. Diabetes.
  4. Impaired renal function.
  5. Impaired liver function.
  6. Cancer.
  7. Hospitalized for two or more days in past 4 weeks.
  8. Requires intubation or tube feeding.
  9. Expected to be transferred to an advanced care unit.
  10. Body mass index of ≥ 40 kg/m2.
  11. Active tuberculosis.
  12. Ascites or severe edema.
  13. Acute Hepatitis or HIV.
  14. Disorder of gastrointestinal tract.
  15. Dementia;brain metastases, eating disorder, significant neurological, psychiatric disorder, other psychological condition.
  16. Medication/dietary supplements/substances that could modulate metabolism or weight.
  17. Partial or full artificial lower limb.
  18. Allergy or intolerance to any of the ingredients in the study products.
  19. Procedure using iodine-based contrast media within 7 days prior to hospitalization; or, anticipated to need procedure using iodine-based contrast media within 3 days after hospital admission.
  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: NCT01477723

Locations
United States, Alabama
Horizon Research Group Inc
Mobile, Alabama, United States, 36608
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Springfield Clinic
Springfield, Illinois, United States, 62703
United States, Maine
Central Maine Medical Center
Lewiston, Maine, United States, 04240
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, North Carolina
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Mount Carmel West Hospital
Columbus, Ohio, United States, 43222
United States, South Carolina
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
United States, Texas
The University of Texas Medical Branch
Galveston, Texas, United States, 77555-1144
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Salem VA Medical Center
Salem, Virginia, United States, 24153
Puerto Rico
Hospital HIMA San Pablo
Bayamon, Puerto Rico, 00959
Manati Medical Center
Manati, Puerto Rico, 00647
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Vikkie Mustad, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01477723     History of Changes
Other Study ID Numbers: BK33
Study First Received: November 19, 2011
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 28, 2014