Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Surgery

Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Hip Fracture Surgery

The objective of this study is to evaluate the effect of nutritional supplementation on the nutritional and clinical course of patients admitted to the hospital for hip fracture surgery.

Inclusion Criteria:

• Subject is > 45 years of age.
• Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
• Subject plans to undergo hip fracture surgery.
• Subject has anticipated length of hospital stay of at least 4 weeks. Subject is able to consume foods and beverages orally.
• Subject has admission total protein ≤ 70 g/L.
• Subject has screening serum albumin ≤ 38 g/L.

Exclusion Criteria:

• Subject is known to be allergic or intolerant to any ingredient found in the study product.
• Subject has pre-planned surgery other than hip fracture surgery during the study period.
• Subject has alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances.
• Subject has active malignancy
• Subject has chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
• Subject has diagnosis of IDDM.
• Subject has uncontrolled NIDDM determined by HbA1c > 8%.