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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01483976
Other study ID # BK96
Secondary ID
Status Completed
Phase Phase 3
First received November 23, 2011
Last updated January 30, 2013
Start date October 2011
Est. completion date May 2012

Study information

Verified date January 2013
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The objective of this study is to verify changes in protein metabolism after ingesting a oral medical nutritional supplement.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Oral medical nutritional supplement
orally over a three hour period
Experimental oral medical nutritional supplement with AN777
orally over a three hour period

Locations

Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

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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