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NCT01477723 Clinical Trial

Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients

Pneumonia Clinical Trial

Official title:
Evaluation of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01477723
Other study ID # BK33
Secondary ID
Status Terminated
Phase Phase 3
First received November 19, 2011
Last updated February 14, 2013
Start date October 2011
Est. completion date November 2012

Study information
Verified date February 2013
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 17
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 55 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Experimental Oral Nutritional Supplement
Experimental ONS orally Two 8 fl oz servings/day

Locations
Country Name City State
Puerto Rico Hospital HIMA San Pablo Bayamon
Puerto Rico Manati Medical Center Manati
United States Medical University of South Carolina (MUSC) Charleston South Carolina
United States Northwestern University Chicago Illinois
United States Mount Carmel West Hospital Columbus Ohio
United States The University of Texas Medical Branch Galveston Texas
United States Central Maine Medical Center Lewiston Maine
United States Horizon Research Group Inc Mobile Alabama
United States Vanderbilt University Medical Center Nashville Tennessee
United States Sentara Norfolk General Hospital Norfolk Virginia
United States William Beaumont Hospital Royal Oak Michigan
United States Salem VA Medical Center Salem Virginia
United States Springfield Clinic Springfield Illinois
United States Wake Forest University Health Sciences Winston Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Abbott Nutrition

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Leg Lean Mass baseline to day 30 No
Secondary Body Weight baseline to day 30 No
Secondary Body Mass Index baseline to day 30 No
Secondary Activities of daily living baseline to day 30 No
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