A Randomized, Double-Blinded, Controlled Trial of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients (Protocol No. BL01)

Service: Trial Number:
Principal Investigator: Conducted at:
Saddleback Medical Center
Currently enrolling additional patients:

The study objective is to observe any differences in the patient’s recovery time and chance of readmission after having been given a regimen of the investigational product as opposed to the standard nutritional beverage provided to hospitalized patients. Elderly patients (ages 65-95 for this study) often experience lean body mass loss (greater than 10% in 3 days) as well as a loss of function while hospitalized, limiting their ability to be independent after hospitalization. In addition, readmission to the hospital is a significant problem. This study proposes that a low nutrient intake during hospitalization is a leading factor in lean body mass loss in elderly patients, and that by supplementing their diet with the investigational product lean body mass loss can be prevented. Consented patients will first go through a screening visit. Once determined to be eligible, a baseline visit will occur in which the patient will be randomized, and data such as the severity of the illness, the patient’s daily activity level, and results of a handgrip strength test the patient will take will be collected. It is at this visit that the investigational product will be dispensed to those randomized to the experimental group, and the standard beverage will be provided to those in the control group. At discharge (and at 30, 60 and 90 days), the patient will be questioned on their quality of life, perform a handgrip strength test, and be informed on how to continue taking the investigational product or standard beverage at home. Weekly telephone calls will help to collect data while the patient is home in between visits. The patient may directly benefit from participation in the study if randomized to the experimental group and the investigational product is shown to help prevent lean body mass loss.