Status:
COMPLETED
Comparison of Medical Nutritional Supplements
Lead Sponsor:
Abbott Nutrition
Conditions:
Elderly
Eligibility:
MALE
60-90 years
Phase:
PHASE3
Brief Summary
The objective of this study is to verify changes in protein metabolism after ingesting a oral medical nutritional supplement.
Eligibility Criteria
Inclusion
- Male and is ≥ 60 and ≤ 90 years of age.
- Body Mass Index (BMI) \> 20.0, but \< 35.0.
- Ability to climb a flight of 10 stairs or walk an equivalent of city block without help within the 3 months prior to enrollment.
- Refrain from taking any dose of NSAIDs or acetaminophen on the day of and 24 hours prior to Visit 2 and Visit 3.
- Refrain from using any pulmonary maintenance medications on the days of Visit 2 and Visit
- Refrain from intense physical activity between visits.
Exclusion
- Systemic corticosteroids within the 3 months prior to enrollment.
- Blood thinner or anticoagulant medication within 1 week prior to enrollment.
- Glomerular filtration rate (eGFR) of \< 40 mL/min/1.73m2.
- Antibiotics within 1 week prior to enrollment.
- Major surgery less than 3 months prior to enrollment in the study.
- Active malignant disease or treated within the last 6 months for cancer.
- Immunodeficiency disorder.
- Diabetes
- Myocardial infarction 3 months prior to enrollment.
- Chronic obstructive pulmonary disease
- History of allergy to any of the ingredients in the study products.
- Conditions precluding ingestion or absorption of the study product, inflammatory bowel disease, short bowel syndrome, or other major gastrointestinal disease.
- Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition.
- Pursuing weight loss or weight gain.
- Medications/dietary supplements/substances that could modulate metabolism or weight.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01483976
Start Date
October 1 2011
End Date
May 1 2012
Last Update
January 31 2013
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205