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Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients

Primary Purpose

Pneumonia

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Experimental Oral Nutritional Supplement
Sponsored by
Abbott Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Horizon Research Group Inc
  • Northwestern University
  • Springfield Clinic
  • Central Maine Medical Center
  • William Beaumont Hospital
  • Wake Forest University Health Sciences
  • Mount Carmel West Hospital
  • Medical University of South Carolina (MUSC)
  • Vanderbilt University Medical Center
  • The University of Texas Medical Branch
  • Sentara Norfolk General Hospital
  • Salem VA Medical Center
  • Hospital HIMA San Pablo
  • Manati Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Oral Nutrition Supplement

No Product

Arm Description

Experimental ONS orally Two 8 fl oz servings/day

Outcomes

Primary Outcome Measures

Leg Lean Mass

Secondary Outcome Measures

Body Weight
Body Mass Index
Activities of daily living

Full Information

First Posted
November 19, 2011
Last Updated
February 14, 2013
Sponsor
Abbott Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT01477723
Brief Title
Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients
Official Title
Evaluation of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Oral Nutrition Supplement
Arm Type
Experimental
Arm Description
Experimental ONS orally Two 8 fl oz servings/day
Arm Title
No Product
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Experimental Oral Nutritional Supplement
Intervention Description
Experimental ONS orally Two 8 fl oz servings/day
Primary Outcome Measure Information:
Title
Leg Lean Mass
Time Frame
baseline to day 30
Secondary Outcome Measure Information:
Title
Body Weight
Time Frame
baseline to day 30
Title
Body Mass Index
Time Frame
baseline to day 30
Title
Activities of daily living
Time Frame
baseline to day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 55 years of age. Admitted to hospital with a disease of respiratory system including acute respiratory diseases (e.g., pneumonia, acute bronchitis) or exacerbation of existing respiratory diseases. Anticipated length of hospital stay of at least 3 days. Ability to climb a flight of 10 stairs or walk a city block without the help of another person prior to hospitalization. Able to consume foods and beverages orally. Exclusion Criteria: Unstable heart failure which requires ICU admission. Severe respiratory disease requiring long-term, continuous oxygen therapy. Diabetes. Impaired renal function. Impaired liver function. Cancer. Hospitalized for two or more days in past 4 weeks. Requires intubation or tube feeding. Expected to be transferred to an advanced care unit. Body mass index of ≥ 40 kg/m2. Active tuberculosis. Ascites or severe edema. Acute Hepatitis or HIV. Disorder of gastrointestinal tract. Dementia;brain metastases, eating disorder, significant neurological, psychiatric disorder, other psychological condition. Medication/dietary supplements/substances that could modulate metabolism or weight. Partial or full artificial lower limb. Allergy or intolerance to any of the ingredients in the study products. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vikkie Mustad, PhD
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
Horizon Research Group Inc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Central Maine Medical Center
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Mount Carmel West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
The University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-1144
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Salem VA Medical Center
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Hospital HIMA San Pablo
City
Bayamon
ZIP/Postal Code
00959
Country
Puerto Rico
Facility Name
Manati Medical Center
City
Manati
ZIP/Postal Code
00647
Country
Puerto Rico

12. IPD Sharing Statement

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Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients

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