Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients

Phase 3

Terminated

• Conditions: Pneumonia
• Interventions: Other: Experimental Oral Nutritional Supplement

• Registration Number: NCT01477723
• Lead Sponsor: Abbott Nutrition

Brief Summary

Study objectives are to verify the loss of lean mass during a hospital stay in a group of older patients; to evaluate the effects of consuming a high-calorie complete and balanced oral nutritional supplement; to collect post-discharge information.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-19
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-22
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-14
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. ≥ 55 years of age.
2. Admitted to hospital with a disease of respiratory system including acute respiratory diseases (e.g., pneumonia, acute bronchitis) or exacerbation of existing respiratory diseases.
3. Anticipated length of hospital stay of at least 3 days.
4. Ability to climb a flight of 10 stairs or walk a city block without the help of another person prior to hospitalization.
5. Able to consume foods and beverages orally.

Exclusion Criteria

1. Unstable heart failure which requires ICU admission.
2. Severe respiratory disease requiring long-term, continuous oxygen therapy.
3. Diabetes.
4. Impaired renal function.
5. Impaired liver function.
6. Cancer.
7. Hospitalized for two or more days in past 4 weeks.
8. Requires intubation or tube feeding.
9. Expected to be transferred to an advanced care unit.
10. Body mass index of ≥ 40 kg/m2.
11. Active tuberculosis.
12. Ascites or severe edema.
13. Acute Hepatitis or HIV.
14. Disorder of gastrointestinal tract.
15. Dementia;brain metastases, eating disorder, significant neurological, psychiatric disorder, other psychological condition.
16. Medication/dietary supplements/substances that could modulate metabolism or weight.
17. Partial or full artificial lower limb.
18. Allergy or intolerance to any of the ingredients in the study products.
19. Procedure using iodine-based contrast media within 7 days prior to hospitalization; or, anticipated to need procedure using iodine-based contrast media within 3 days after hospital admission.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Oral Nutrition Supplement	Experimental Oral Nutritional Supplement	Experimental ONS orally Two 8 fl oz servings/day

Primary Outcome Measures

Name	Time	Method
Leg Lean Mass	baseline to day 30

Secondary Outcome Measures

Name	Time	Method
Body Weight	baseline to day 30
Body Mass Index	baseline to day 30
Activities of daily living	baseline to day 30

Trial Locations

Locations (14)

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

The University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Mount Carmel West Hospital; 🇺🇸 Columbus, Ohio, United States

Horizon Research Group Inc; 🇺🇸 Mobile, Alabama, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Springfield Clinic; 🇺🇸 Springfield, Illinois, United States

Wake Forest University Health Sciences; 🇺🇸 Winston Salem, North Carolina, United States

Central Maine Medical Center; 🇺🇸 Lewiston, Maine, United States

Medical University of South Carolina (MUSC); 🇺🇸 Charleston, South Carolina, United States

Hospital HIMA San Pablo; 🇵🇷 Bayamon, Puerto Rico

Manati Medical Center; 🇵🇷 Manati, Puerto Rico

Salem VA Medical Center; 🇺🇸 Salem, Virginia, United States

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States