Status:
COMPLETED
Evaluation of an Oral Nutritional Supplement Containing AN777
Lead Sponsor:
Abbott Nutrition
Conditions:
Malnutrition
Sarcopenia
Eligibility:
All Genders
65-90 years
Phase:
PHASE3
Brief Summary
To evaluate the effect of an experimental oral nutritional supplement containing AN777 compared to another oral nutritional supplement in a malnourished, elderly population.
Eligibility Criteria
Inclusion
- Subject (male or female) is \> or equal to 65 and \< or equal to 90 years of age
- Subject is ambulatory
- Subject has a Subjective Global Assessment of B or C
- Subject has gait speed \<0.8 m/s AND/OR low hand-grip strength
- Subject has Class 1 or Class 2 sarcopenia
- Subject agrees to refrain from starting a resistance exercise program
Exclusion
- Subject has type 1 or type 2 diabetes
- Subject has inflammatory disease with elevated high sensitivity C-reactive protein
- Subject has renal function impairment
- Subject reports gastrointestinal disorder (severe chronic diarrhea, nausea, vomiting) that would preclude ingestion of the study product; an obstruction of the gastrointestinal tract, inflammatory bowel disease; short bowel syndrome or other major gastrointestinal disease
- Subject reports of current active malignant disease or other significant medical diagnoses.
- Subject reports a history of allergy to any of the ingredients in the study products
- Subject reports currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or weight.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT01191125
Start Date
February 1 2011
End Date
September 1 2012
Last Update
March 7 2013
Active Locations (23)
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1
University of Alabama, Brimingham
Birmington, Alabama, United States, 35294
2
Radiant Research, Inc
Santa Rosa, California, United States, 95405
3
Provident Clinical Research
Addison, Illinois, United States, 60101
4
Radiant Research, Inc
Chicago, Illinois, United States, 60654