An Observational Study of a Nutritional Supplement in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population

Study Overview
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Brief Summary
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This non-interventional, prospective, observational study is designed to observe the use of high calorie, high protein oral nutritional supplement in malnourished or at risk of malnutrition patients after hip fracture surgery, as assessed by a clinician. Subjects will be enrolled and observed for a period of 12 weeks.

Official Title
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A Prospective, Observational Study of the Effect of a High Calorie and Protein Oral Nutritional Supplement, in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population

Conditions
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Malnutrition

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study. Subject is considered malnourished, or is at risk for malnutrition Subject conforms to the requirements set forth on the study product label. Subject has an estimated, or measured, glomerular filtration rate >30ml/min/1.73m2 (MDRD equation). Subject has been elected for hip fracture surgery and is within three days since surgery. The study physician determines the subject is fit to participate. Subject is under the care of a health care professional for malnutrition, or is at risk for malnutrition, and has recently been prescribed study oral nutritional supplement by their health care professional. After surgery, the subject is free living, resides in a nursing home, or remains in hospital and has an expected length of hospital stay < 15 days. Exclusion Criteria: Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption AND does not have a caregiver who can assist them with adherence to the study protocol. Subject has active cancer and the study physician determines the subject is not suitable for the study. Subject has uncontrolled diabetes. Subject is known to be allergic or intolerant to any ingredient found in the study product. Participation in another study that has not been approved as a concomitant study.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional Status | Measured by the Mini Nutritional Assessment (MNA) 18 questions; 30 total point scale where lower number indicates risk of malnutrition | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index of Activities of Daily Living | Subject completed assessment of 10 functions; Sum of scores range from 0-100 scaled in positive direction | Baseline to Week 12 | 
| Functional Ambulation Classification Scale (FAC) | 6-level scale assesses ambulation status; scaled in the positive direction; the higher level indicates greater ambulation | Baseline to Week 12 | 
| Short Physical Performance Battery (SPPB) | Timed assessments of balance, gait speed and chair standing; Scaled in the negative direction | Week 12 | 
| Compliance with Nutritional Supplement | Subject completed consumption dairy | Baseline to Week 12 |