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TerminatedNCT01477723Updated Feb 15, 2013

Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients

A Phase 3 interventional study of Experimental Oral Nutritional Supplement in Pneumonia, sponsored by Abbott Nutrition. Terminated at 14 sites in 2 countries. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2013-02-15.

Sponsored by Abbott Nutrition · Phase 3, Interventional, and Treatment

Why this study was terminated
Low enrollment
Phase
Phase 3
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pneumonia

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03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 17 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Experimental Oral Nutrition Supplement

    Experimental ONS orally Two 8 fl oz servings/day

    Other: Experimental Oral Nutritional Supplement

  • No intervention
    No Product

Interventions

  • OtherExperimental Oral Nutritional Supplement

    Experimental ONS orally Two 8 fl oz servings/day

06

What researchers measure

Primary outcomes

  1. Leg Lean Mass

    Time frame: baseline to day 30

Secondary outcomes

  1. Body Weight

    Time frame: baseline to day 30

  2. Body Mass Index

    Time frame: baseline to day 30

  3. Activities of daily living

    Time frame: baseline to day 30

07

Study locations

14 sites
  • Horizon Research Group Inc
    Mobile, Alabama 36608, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Springfield Clinic
    Springfield, Illinois 62703, United States
  • Central Maine Medical Center
    Lewiston, Maine 04240, United States
  • William Beaumont Hospital
    Royal Oak, Michigan 48073, United States
  • Wake Forest University Health Sciences
    Winston Salem, North Carolina 27157, United States
  • Mount Carmel West Hospital
    Columbus, Ohio 43222, United States
  • Medical University of South Carolina (MUSC)
    Charleston, South Carolina 29425, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37212, United States
  • The University of Texas Medical Branch
    Galveston, Texas 77555-1144, United States
  • Sentara Norfolk General Hospital
    Norfolk, Virginia 23507, United States
  • Salem VA Medical Center
    Salem, Virginia 24153, United States
  • Hospital HIMA San Pablo
    Bayamon, 00959, Puerto Rico
  • Manati Medical Center
    Manati, 00647, Puerto Rico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01477723
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Nov 22, 2011
Start date
Oct 2011
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Feb 15, 2013

Study contacts

Vikkie Mustad, PhD
study chair · Abbott Nutrition

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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