Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Pneumonia

Intervention / Treatment
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* Other: Experimental Oral Nutritional Supplement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Oral Nutrition Supplement<br>Experimental ONS orally Two 8 fl oz servings/day | Other: Experimental Oral Nutritional Supplement<br>* Experimental ONS orally Two 8 fl oz servings/day<br>|
| No Intervention: No Product<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg Lean Mass |  | baseline to day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight |  | baseline to day 30 | 
| Body Mass Index |  | baseline to day 30 | 
| Activities of daily living |  | baseline to day 30 |