Clinical trial NCT01477723: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pneumonia
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 17
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Leg Lean Mass
timeFrame: baseline to day 30
Secondary outcomes:
measure: Body Weight
timeFrame: baseline to day 30
measure: Body Mass Index
timeFrame: baseline to day 30
measure: Activities of daily living
timeFrame: baseline to day 30
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Horizon Research Group Inc
state: Alabama
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Lewiston
country: United States
facility: Central Maine Medical Center
state: Maine
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Winston Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Columbus
country: United States
facility: Mount Carmel West Hospital
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Salem
country: United States
facility: Salem VA Medical Center
state: Virginia
city: Bayamon
country: Puerto Rico
facility: Hospital HIMA San Pablo
city: Manati
country: Puerto Rico
facility: Manati Medical Center
Study officials:
affiliation: Abbott Nutrition
name: Vikkie Mustad, PhD
role: STUDY_CHAIR
References: