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

Abbott

Status and phase

Completed

Phase 3

Conditions

Hip Fracture

Treatments

Other: standard hospital food

Other: Medical Food Supplement

Study type

Interventional

Funder types

Industry

Identifiers

NCT01011608

BK52

Details and patient eligibility

About

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.

Enrollment

127 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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%.