Pneumonia
Conditions
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.
Interventions
OTHERExperimental Oral Nutritional Supplement
Experimental ONS orally Two 8 fl oz servings/day
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Leg Lean Mass | baseline to day 30 |
Secondary
| Measure | Time frame |
|---|---|
| Body Weight | baseline to day 30 |
| Body Mass Index | baseline to day 30 |
| Activities of daily living | baseline to day 30 |
Countries
Puerto Rico, United States
Outcome results
None listed