Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients

Stopped early · Phase 3

Conditions studied: Pneumonia

In brief

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.

Key facts

Study ID

NCT01477723

Run by

Abbott Nutrition

People needed

17

Starts

2011-10-01

Expected to finish

2012-11-01

Last updated by the study team

2013-02-15

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.