Comparison of Medical Nutritional Supplements

Elderly Clinical Trial

Official title:

Comparison of Medical Nutritional Supplements With or Without AN777 in Elderly Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483976
• Other study ID #: BK96
• 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

• Elderly

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