Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01477723
Recruitment Status : Terminated (Low enrollment)
First Posted : November 22, 2011
Last Update Posted : February 15, 2013
Information provided by (Responsible Party):
Abbott Nutrition

Brief Summary:
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 or disease Intervention/treatment Phase
Pneumonia Other: Experimental Oral Nutritional Supplement Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients
Study Start Date : October 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Leg Lean Mass [ Time Frame: baseline to day 30 ]

Secondary Outcome Measures :
  1. Body Weight [ Time Frame: baseline to day 30 ]
  2. Body Mass Index [ Time Frame: baseline to day 30 ]
  3. Activities of daily living [ Time Frame: baseline to day 30 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01477723

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
Study Chair: Vikkie Mustad, PhD Abbott Nutrition

Responsible Party: Abbott Nutrition Identifier: NCT01477723     History of Changes
Other Study ID Numbers: BK33
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

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