Elderly Clinical Trial
Official title:
Comparison of Medical Nutritional Supplements With or Without AN777 in Elderly Men
Verified date | January 2013 |
Source | Abbott Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The objective of this study is to verify changes in protein metabolism after ingesting a oral medical nutritional supplement.
Status | Completed |
Enrollment | 27 |
Est. completion date | May 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 60 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
Abbott Nutrition |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in protein metabolism | Via amino acid tracers | Between baseline and 8 hours later | No |
Secondary | Intracellular signaling pathway metabolism | Via Amino acid tracers and protein phosphorylation measurements | Between Baseline and 8 hours later | No |
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