Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients

NCT ID: NCT01477723

Last Updated: 2013-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-11-30

Brief Summary

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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

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Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Oral Nutrition Supplement

Experimental ONS orally Two 8 fl oz servings/day

Group Type EXPERIMENTAL

Experimental Oral Nutritional Supplement

Intervention Type OTHER

Experimental ONS orally Two 8 fl oz servings/day

No Product

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental Oral Nutritional Supplement

Experimental ONS orally Two 8 fl oz servings/day

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vikkie Mustad, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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Horizon Research Group Inc

Mobile, Alabama, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Springfield Clinic

Springfield, Illinois, United States

Site Status

Central Maine Medical Center

Lewiston, Maine, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Mount Carmel West Hospital

Columbus, Ohio, United States

Site Status

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

The University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status

Salem VA Medical Center

Salem, Virginia, United States

Site Status

Hospital HIMA San Pablo

Bayamón, Puerto Rico, Puerto Rico

Site Status

Manati Medical Center

Manatí, Puerto Rico, Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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BK33

Identifier Type: -

Identifier Source: org_study_id

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