NCT01477723TerminatedPhase 3
Evaluation of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Abbott Nutrition
- Enrollment
- 17
- Locations
- 14
- Primary Endpoint
- Leg Lean Mass
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Impaired renal function.
- •Impaired liver function.
- •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/m
- •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.
Arms & Interventions
No Product
No Intervention
Experimental Oral Nutrition Supplement
Experimental
Experimental ONS orally Two 8 fl oz servings/day
Intervention: Experimental Oral Nutritional Supplement (Other)
Outcomes
Primary Outcomes
Leg Lean Mass
Time Frame: baseline to day 30
Secondary Outcomes
- Body Weight(baseline to day 30)
- Body Mass Index(baseline to day 30)
- Activities of daily living(baseline to day 30)
Investigators
Study Sites (14)
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