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Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients

Sponsor
Abbott Nutrition (Industry)
Overall Status
Terminated
CT.gov ID
NCT01477723
Collaborator
(none)
17
Enrollment
14
Locations
2
Arms
13
Duration (Months)
1.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Experimental Oral Nutritional Supplement
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Nov 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Oral Nutrition Supplement

Experimental ONS orally Two 8 fl oz servings/day

Other: Experimental Oral Nutritional Supplement
Experimental ONS orally Two 8 fl oz servings/day
No Intervention: No Product

Outcome Measures

Primary Outcome Measures

  1. Leg Lean Mass [baseline to day 30]

Secondary Outcome Measures

  1. Body Weight [baseline to day 30]

  2. Body Mass Index [baseline to day 30]

  3. Activities of daily living [baseline to day 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
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:

  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Horizon Research Group Inc Mobile Alabama United States 36608
2 Northwestern University Chicago Illinois United States 60611
3 Springfield Clinic Springfield Illinois United States 62703
4 Central Maine Medical Center Lewiston Maine United States 04240
5 William Beaumont Hospital Royal Oak Michigan United States 48073
6 Wake Forest University Health Sciences Winston Salem North Carolina United States 27157
7 Mount Carmel West Hospital Columbus Ohio United States 43222
8 Medical University of South Carolina (MUSC) Charleston South Carolina United States 29425
9 Vanderbilt University Medical Center Nashville Tennessee United States 37212
10 The University of Texas Medical Branch Galveston Texas United States 77555-1144
11 Sentara Norfolk General Hospital Norfolk Virginia United States 23507
12 Salem VA Medical Center Salem Virginia United States 24153
13 Hospital HIMA San Pablo Bayamon Puerto Rico 00959
14 Manati Medical Center Manati Puerto Rico 00647

Sponsors and Collaborators

  • Abbott Nutrition

Investigators

  • Study Chair: Vikkie Mustad, PhD, Abbott Nutrition

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01477723
Other Study ID Numbers:
  • BK33
First Posted:
Nov 22, 2011
Last Update Posted:
Feb 15, 2013
Last Verified:
Feb 1, 2013
Additional relevant MeSH terms:
Pneumonia

Study Results

No Results Posted as of Feb 15, 2013