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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01011608

Enrollment

127

Registered

2009-11-11

Start date

2009-11-30

Completion date

2010-09-30

Last updated

2011-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fracture

Brief summary

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.

Interventions

OTHERMedical Food Supplement

Medical Food Supplement to be given in divided portions in morning, afternoon and evening

OTHERstandard hospital food

standard hospital diet ad. lib.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

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%.

Design outcomes

Primary

Measure	Time frame
Blood chemistry	28 days

Secondary

Measure	Time frame
Product intake	28 days
Functionality (pain, mobility, strength)	28 days
Surgical site status	28 days

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026